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  • Shshonee (Alley)
    ... From: Alley To: GIWorld-Hepatitis@yahoogroups.com ; Happy Heppers Sent: Sunday, May 01, 2005 6:24 PM Subject: Fw: HepC Newsletter ... From: Charles
    Message 1 of 4 , May 1, 2005
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      ----- Original Message -----
      From: Alley
      To: GIWorld-Hepatitis@yahoogroups.com ; Happy Heppers
      Sent: Sunday, May 01, 2005 6:24 PM
      Subject: Fw: HepC Newsletter



      ----- Original Message -----
      From: Charles Demastus
      To: HepC@...
      Sent: Sunday, May 01, 2005 9:34 AM
      Subject: HepC Newsletter


      HEPATITIS C NEWSLETTER
      is news & views related to hepatitis C (alternative
      treatments and advances in medical treatment)
      It is FREE and sent to you via E-mail.
      To subscribe send blank e-mail to:
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      HBV DNA (viral load) Predicts Liver Cirrhosis

      Reported by Jules Levin

      These two studies are among several presented at the 40th annual EASL meeting (April 2005, Paris) finding that HBV DNA levels (viral load) are associated with disease progression, that reducing viral load (virus replication) can reduce the risk for disease progression to cirrhosis, liver cancer & death. The incidence of liver cirrhosis in HBV increases as HBV viral load increases. The data from these studies suggest reducing viral load as low as possible to <300 copies/ml may be of benefit compared to a level of 10,000 copies/ml or perhaps to 1,000 copies/ml although this may be more debatable. Other studies at the meeting found that the incidence of liver cancer also increased as the HBV viral load increased. The strong suggestion from these studies is that reducing HBV viral load reduces risk for serious disease in HBV.

      Some questions are: when to begin HBV therapy since therapy can be ongoing & not of time limited duration as in HCV; should peginterferon be the initial attempt with therapy since peginterferon therapy is time limited; should combination therapy be used: the potential benefits of combination therapy have not yet been well characterized; the only benefit so for identified with combination therapy is that it appears to reduce the development of drug resistance. Idenix Pharmaceuticals has reported data in the woodchuck model that there two HBV drugs (LdC & LdT) in combination reduce viral load additively, but clinical studies will have to confirm this finding. Of note, the authors of the first study showed data on incidence of cirrhosis in patients with undetectable HBV DNA & concluded that “even the absence of HBV DNA does not eliminate the risk of future cirrhosis. The second study below finds that these findings apply to both HBeAg negative & positive patients.

      “SERUM HEPATITIS B VIRUS DNA LEVEL PREDICTS THE INCIDENCE OF LIVER CIRRHOSIS IN PERSONS CHRONICALLY INFECTED WITH HBV”

      U.H. Iloeje1, H.I. Yang2, J. Su1, C.L. Jen2, E. Kuo3, S.L. You2, C.J. Chen2

      1 Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT, USA
      2 National Taiwan University, Taipei, Taiwan
      3 Bristol-Myers Squibb, Taipei, Taiwan

      Chronic hepatitis B patients are at increased risk of developing liver cirrhosis. Cirrhosis develops as a result of hepatic inflammation and subsequent fibrosis. Ongoing viral replication is associated with hepatic inflammatory activity and suppression of viral replication in clinical trials is associated with improvements in liver histology. An association between elevated HBV DNA level and progression to cirrhosis has not been shown in a large epidemiological setting. This study was carried out to examine if increasing levels of HBV DNA is associated with increasing risk of cirrhosis.

      A population based prospective cohort study of 3851 HBV infected subjects was established from seven townships in Taiwan between 1991 and 1992. Cohort entry serum samples were tested for HBV DNA by PCR, and the diagnosis of cirrhosis was by ultrasonography and ascertained by medical records review. Cirrhosis incidence rate per person year of follow-up (PYFU) for each strata of HBV DNA was calculated. The multivariable adjusted relative risk (RRadj) was derived from Cox's proportional hazard models.

      Results

      Of the 3851 subjects, 77 subjects were excluded (75 diagnosed with cirrhosis and 2 dying within 6 months of enrollment) leaving 3774 subjects. During 42,114.9 person-years of follow-up, 395 cirrhosis cases were newly diagnosed.

      The incidence rate of cirrhosis ranged from 386.1/100,000 PYFU for those with HBV DNA <300 copies/ml to 2575.7/100,000 PYFU for those with HBV DNA e106 copies/ml (test of trend: p < 0.0001) in a dose dependent manner.

      With the undetectable group as reference, and adjusting for gender, age, habits of cigarette smoking, and alcohol consumption, and antibodies against hepatitis C virus, the risk of cirrhosis started increasing at HBV DNA level of 104 (10,000 copies/ml), RRadj 2.4 (95%CI: 1.6-3.5), and was 9.3 (95%CI: 6.5-13.1) for those who had serum HBV DNA level >106 copies/ml (1 million copies/ml).


      CUMULATIVE INCIDENCE OF LIVER CIRRHOSIS for the HBV DNA LEVELS (n=3,774), p value for log rank test, <0.001

      HBV DNA LEVELS Cum. Incidence Liver Cirrhosis
      <300 copies/ml 5.2%
      300-9.9x103 6.3%
      1.0-9.9x104 10.0%
      1.0-9.9x105 23%
      >106 37%

      The 1,620 (43%) subjects with HBV DNA of 10,000 copies/ml or more accounted for 289 (73%) of the cirrhosis cases.

      The incidence of cirrhosis even in the subjects with undetectable HBV DNA was 386.1 per 100,000 person-years, showing that even the absence of dectetable HBV DNA does not eliminate the risk of future cirrhosis.

      Author Conclusions
      HBV DNA level is a strong predictor of cirrhosis risk. The incidence of cirrhosis increases with HBV DNA level in a dose dependent manner. It is expected therefore that reducing the HBV DNA should conversely decrease cirrhosis risk in chronic hepatitis B patients.

      2nd Study

      “VIRAL LOAD IS A STRONG PREDICTOR OF LIVER CIRRHOSIS RISK IN PEOPLE CHRONICALLY INFECTED WITH HEPATITIS B VIRUS REGARDLESS OF HEPATITIS B e ANTIGEN STATUS”

      “….reducing the viral replication should result in lower cirrhosis risk in both HBeAg positive & negative subjects.”

      C.J. Chen1, H.I. Yang1, J. Su2, C.L. Jen1, E. Kuo3, S.L. You1, U.H. Iloeje2

      1 National Taiwan University, Taipei, Taiwan
      2 Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, USA
      3 Bristol-Myers Squibb, Taipei, Taiwan


      HBeAg is considered a marker of active viral replication often associated with high levels of viremia. This study was carried out to examine the impact of HBV DNA level on the risk of disease progression to cirrhosis stratified by HBeAg status.

      A population based prospective cohort of 3851 subjects chronically infected with HBV was established was from seven townships in Taiwan between 1991 and 1992. Subjects were prospectively followed by hepatologists by clinical examinations including ultrasonography through June 30th 2004. The diagnosis of cirrhosis was based on ultrasonographic findings. All cirrhosis cases diagnosed within 6 months of enrollment were excluded from analyses. Multivariable adjusted relative risks (RRadj) were derived using Cox proportional hazard models.

      Results

      Overall, 3774 subjects with 42,115 person years of follow up contributed data to this analysis. There were 395 cases of cirrhosis.

      Of the 3774 participants, 3214 (85%) were seronegative for HBeAg, of which 1082 (34%) had serum HBV DNA level e104 copies/ml; 560 (15%) were HBeAg positive of which 538 (96%) had serum HBV DNA e104 copies/ml at enrollment. There was a dose dependent relationship between HBV DNA and cirrhosis risk within the HBeAg strata.

      With the HBeAg negative undetectable DNA group as reference, the highest risk of progression was found in the HBeAg positive group with HBD DNA over 105 copies/ml (>100,000 copies/ml).

      Subjects with HBV DNA level of 1.0-9.9x10 to the 5th and >1 million (10 to the 6th) had very similar incidence rates of cirrhosis regardless of HBeAg status.



      Author Conclusion: Elevated serum HBV DNA is a strong predictor of cirrhosis risk in HBV infected persons regardless of HBeAg status. Effective suppression of HBV DNA to very low levels especially in HBeAg negative persons could reduce progression of CHB to cirrhosis.



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      Diabetes & Lipids Associated with Liver Disease

      Reported by Jules Levin

      These studies were reported at the 40th annual EASL liver meeting in Paris (April 2005). The studies support numerous previous studies that insulin resistance and diabetes can contribute to advancing liver disease, particularly in people with viral hepatitis C or B. As well, elevated lipids may contribute.

      Impact of Overweight & Diabetes on Liver-Related Death in Patients with Alcoholic & Viral Hepatitis C Cirrhosis

      G. N'Kontchou1, M. Tin Tin Htar1, J. Paries2, F. Kazemi1, V. Bourcier1, N. Ganne-Carrie1, P. Nahon1, V. Grando-Lemaire1, J.C. Trinchet1, M. Beaugrand1

      1 Liver Unit, Jean Verdier Hospital, Bondy, France
      2 Public Health Unit, Jean Verdier Hospital, Bondy, France


      Obesity and diabetes have been suggested to be risk factors of liver-related death in recent population-based cohort studies. This study was aimed to assess prospectively the impact of these factors on liver-related death (including liver transplantation).

      Overweight & diabetes type II are risk factors of cirrhosis in patients with alcoholic & viral HCV. They are also risk factors for liver cancer (hepatocellular carcinoma). Their influence on liver-related death in patients has not yet been evaluated.

      A large cohoht of 963 patients with compensated cirrhosis regularly followed for a screening program for HCC were included. All clinical and biological variables were collected at inclusion. Ultrasonography & alfa-feto protein were used for follow-up evaluation. Outcomes evaluated were: liver-related death, liver-related death including liver transplantation (HCC, liver failure, portal hypertension), & occurrence of HCC was also recorded.

      Predictive factors for overall and liver-related death were determined by log-rank test and Cox proportional hazards model. Survival to events was estimated by Kaplan-Meier method.

      BASELINE CHARACTERISTICS n=963:
      Age: 57
      63% male
      Etiologies: (alcohol/HCV/mixed): 484/322/157
      Diabetes: 298 (31%)
      BMI (kg/m2): 25/6 +/-4.7
      Prothrombine time: 72+/-17
      Platelet counts: 137 +/-64
      Bilirubin: 28 mmol/l
      Albumin (g/l): 39+/-6
      AST (N): 2
      ALT (N): 2
      AP (N): 1.4
      y-GT (N): 3.9

      Results
      -There were 484 alcoholic cirrhosis, 322 HCV, 157 HCV+alcohol.
      -Mean age was 57.2±11 yr and mean BMI was 25.6 kg/m2.
      -607 were male patients.
      -298 patients were diabetic.
      -After a mean follow-up of 66.7±45.2 months, 384 patients died, of which 279 were liver-related deaths (liver failure: 142; hepatocellular carcinoma: 117; portal hypertension: 20).

      In univariate analysis, factors associated with liver-related death were:
      --BMI e27.5 [OR 1.9; 1.5-2.4; p < 0.0001]
      --age >57 yr [OR 1.6; 1.3-2.0; p < 0.0001]
      --male sex [1.7; 1.3-2.1; p < 0.0001]
      --platelet count <140,000/mm3 [OR 1.9; 1.5-2.5; <0.0001]
      --serum albumin <42 g/l [2.8; 2.0-3.9; p < 0.0001]
      --prothrombin activity <82% [2.3; 1.7-3.1; p < 0.0001]
      --alkaline phosphatase >1.4 ULN [OR 1.9; 1.5-2.4; p < 0.0001]
      --total bilirubin >17 mm/ml [OR 1.9; 1.5-2.4, p < 0.0001].

      Diabetes was not significantly related.

      In multivariate analysis, independent risk factors for liver-related death were:
      --serum albumin <42 g/l [OR 2.00; 1.4-2.9; p = 0.0004]
      --BMI e27.5: [OR 1.8; 1.4-2.4; p < 0.0001]
      --age >57 yr [OR 1.7; 1.3-2.3; p = 0.0002]
      --male sex [OR 1.5; 1.1-2.1; p = 0.01]
      --prothrombin activity <82% [OR 1.6; 1.1-2.2 p = 0.02]
      --alkaline phosphatase >1.4 ULN [OR 1.4; 1.0-1.9; p = 0.03].

      These results were confirmed in different etiological subgroups.

      Conclusion: Overweight was an independent and important predictive factor of liver-related death in patients with compensated HCV and alcohol cirrhosis.

      Diabetes is Strongly Associated with Advanced Fibrosis;
      Elevated Lipids May Be Associated with Fibrosis
      --Patient Populations with High prevalence of Diabetes, like Hispanics, May Be Particularly At Risk for Advancing Liver Disease

      “ASSOCIATION BETWEEN DIABETES, OVERWEIGHT, OBESITY AND DYSLIPIDEMIA WITH FIBROSIS PROGRESSION IN CHRONIC HEPATITIS C PATIENTS”

      A. Loaeza-del Castillo, F. Vargas-Vorácková

      1 Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición, Mexico
      2 Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición, Mexico

      Fibrosis progression in chronic hepatitis C (CHC) patients is variable, factors associated with an accelerated progression have been identified, but they do not account for the heterogeneity seen between individuals.

      Aim: To determine the prevalence of diabetes, overweight, obesity and dyslipidemia in CHC patients and the association of these metabolic factors with liver fibrosis progression.

      Method: Patients with CHC seen in our institution between 1993 and 2003 were retrospectively studied (n = 1618). Patients with a known duration of infection acquired by transfusion with a liver biopsy performed before any antiviral treatment were included. Patients with overt hepatic insufficiency were excluded. The diagnoses of diabetes, overweight, obesity and dyslipidemia were investigated and liver fibrosis stage (METAVIR). Variables were tested for their association with significant fibrosis (F2, F3, F4).

      RESULTS
      --108 patients were included, 71 (66%) female and 37 (34%) male,
      --mean age was 48.7+12.2 years.
      --Age at infection was 24.7±13 years, acquired between 1944-2000.
      --78% were HCV-genotype 1.
      --Fibrosis stage was: F0 = 15 (14%), F1 = 38 (35%), F2 = 9 (8%), F3 = 8 (8%) and F4 = 38 (35%).
      --Mean fibrosis progression rate was 0.106±0.101 (0-0.44).
      --26 patients (24%) had diabetes, 10 (9%) glucose intolerance, 24 (22%) obesity [body mass index (BMI) e30 kg/m2] and 49 (45%) overweight (25 d BMI < 30 kg/m2).
      --Dyslipidemia was investigated in 75 patients and confirmed in 25 (33.3%). Association between these variables and fibrosis is depicted in the table.



      Variable Odds ratio 95%CI P


      F2-F4
      Diabetes 3.56 1.35-9.42 0.008
      Overweight 1.006 0.47-2.14 0.98
      Obesity 1.18 0.47-2.93 0.71
      Dyslipidemia 0.33 0.13-0.86 0.02
      Cirrhosis
      Diabetes 2.94 1.18-11.9 0.01
      Overweight 0.96 0.43-2.12 0.92
      Obesity 1.48 0.56-3.61 0.45
      Dyslipidemia 0.36 0.12-1.06 0.05



      Conclusions: Diabetes is a factor strongly associated with advanced fibrosis and cirrhosis. In populations with a high prevalence of diabetes, such as Hispanics, this association must be taken into account. Lipid metabolism has a specific role in the pathogenesis of CHC and the possible protector role of dyslipidemia for significant liver fibrosis should be investigated in further studies.


      “INSULIN RESISTANCE PROMOTES FIBROSIS PROGRESSION AND PREDICTS NECRO-INFLAMMATORY ACTIVITY IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE”

      D. Sánchez-Muñoz1, E. Suárez1, M.V. Galán1, L. Grande1, G. Muñoz2, M. Romero-Gómez1

      1 Hepatology Unit, Hospital Universitario de Valme, Sevilla, Spain
      2 Pathology Unit, Hospital Universitario de Valme, Sevilla, Spain


      Aims: To assess the presence of metabolic syndrome X (MSx) and insulin resistance (IR), and its relationship with histologic damage, in patients with non-alcoholic fatty liver disease (NAFLD).

      Patients and Methods: Thirty-five patients, 25 male and 10 female, with an average age of 45.7±12.7 [24-76] years, diagnosed by NAFLD, were included. Liver biopsy was carried out after persistence for, at least, six months of altered liver enzymes with appropriate diet and physical activity therapies. Histological damage was assessed according to Brunt criteria (Semin Liver Dis 2001; 21: 3-16). Body mass index (BMI) was calculated. MSx was diagnosed according to ATP III criteria. IR was calculated using the HOMA-IR index = [Glucose(mmol/l) _ Insulin(UI/ml)]/22.5.

      RESULTS

      Only one patient (2.5%) showed normal weight; 17/35 (48.6%) patients showed overweight and 17/35 (48.6%) patients were obese.
      --MSx was present in 14/35 (42.5%) patients;
      --central obesity in 65.7%,
      --high triglyceride levels in 62.9%,
      --altered glucose metabolism in 28.6%,
      --hypertension in 31.4% and
      --low HDL-colesterol levels in 24%.
      --IR was present (HOMA-IR >2) in 23/33 (74.3%) patients.
      --The histologic diagnosis was simple hepatocyte steatosis (HS) in 8/35 (22.9%) patients and steatohepatitis (NASH) in 27/35 (77.1%) patients: Fibrosis degree was: absent in 13 patients, mild fibrosis (F1-F2) in 6 patients, bridging fibrosis (F3) in 7 patients and cirrhosis (F4) in 1 patient.

      Patients with HS showed lower triglyceride levels (99±43 vs 169±85 mg/dl; p = 0.034) and HOMA-IR (2.54±0.9 vs 4.5±2.5; p = 0.002) than patients with NASH.

      Triglycerides >180 mg/dl or HOMA IR >4.5 was associated with NASH (Specificity: 100% and Sensitivity: 54.3%.

      Fibrosis correlated with age (r = 0.37; p = 0.027), AST (r = 0.5; p = 0.002), and HOMA-IR (r = 0.45; p = 0.007).

      In multiple lineal regression, the only factor associated with fibrosis was the HOMA-IR (R = 0.60; p = 0.0001). All of the patients with advanced fibrosis (F3-F4) showed a HOMA-IR index >4.5, but only 8/26 (30%) patients with F0-F2; p < 0.001.

      Conclusions: Insulin resistance is present in the majority of the patients with non-alcoholic fatty liver disease. HOMA-IR index >4.5 or triglyceride levels >180 mg/dl are predictors of the presence of NASH. Insulin resistance may play a role in the pathogenesis of fibrosis progression in patients with NAFLD. Drugs able to decrease insulin resistance could be useful in the therapy of this disease.


      Total Calories May Contribute to Development of Fatty Liver

      “LIVER STEATOSIS (Fatty Liver) IN OPEN POPULATION: PREVALENCE AND RELATIONSHIP TO THE DIET. PRELIMINARY RESULTS OF THE ``ARSITA-ONE'' PROJECT”

      I. Petridis1, E. Lattanzi1, B. Marraccini1, I. Carderi1, E. Claar1, C. Liani1, S. Lobello1, O. Di Andrea2, M. Chiaramonte1

      1 Hepato-Gastroenterology and Nutrition Unit - Dept. of Internal Medicine and Public Health - L'Aquila University, L'Aquila, Italy
      2 Arsita Family Doctor, Italy


      Background and Aim: This study, part of a larger epidemiological study for liver and metabolic diseases carried out on Arsita (Abruzzo) (805 adult registered inhabitants), was designed: 1) to assess the prevalence of liver steatosis; 2) to evaluate the relationship with the diet.

      Materials and Methods: All subjects aged over 18 yr were invited to have liver ultrasound (US) and an alimentary questionnaire computer analyzed (Winfood 1.5). Liver steatosis was classified as none, mild, moderate and severe. Diet was classified as: diet 1, a traditional local diet, hypercaloric (3500-4500 kcal), hyperlipidic (55% of calories); diet 2, similar but with less calories (2500-3500 kcal); diet 3, classic Mediterranean (2000-2500 kcal).

      RESULTS
      --541 subjects (253 M and 288 F), completed the US and diet study.
      --Moderate/severe steatosis was found in 89/253 (35%) males and 75/288 (26%) females; in 41/164 (25%) subjects under 40 yr, in 63/119 (33%) subjects aged 40-59 yrs and in 92/196 (47%) subjects over 60 yr.
      --143/253 males (57.5%) and 86/288 females (30%) followed diet 1, which was related to obesity (BMI > 30) in 61% of males and 69% of females, while 14% of subjects having diet 2 were obese.

      --All subjects with mediterranean diet had normal BMI.
      --In diet 1 group, 71.5% of males and 64.5% of females had steatosis, while in diet 2 this was respectively 25.1% and 31.3%.
      --In subjects with steatosis, alcohol consumption was present in 82% of males and in 48% of females, while BMI > 30 was present in 61% of males and 78% of females.
      --Out of 164 subjects with steatosis 22 (13%) had altered AST and/or ALT (13 anti-HCV+).

      Conclusions: Prevalence of steatosis is increasing with age and is more frequent in males. In females severe steatosis is mainly correlated with overweight and in males with alcohol abuse. The amount of total calories instead of the proportion of fat seems to be related to liver steatosis. Elderly people had moderate/severe in 47%, however in most cases steatosis is indolent. Hepato cytolisis, without virus, seems to be very rare. Liver steatosis without ``a second hit'' seems to be a benign condition.

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    • Shshonee (Alley)
      HEPATITIS C NEWSLETTER is news & views related to hepatitis C (alternative treatments and advances in medical treatment) It is FREE and sent to you via E-mail.
      Message 2 of 4 , Jul 2, 2005
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        HEPATITIS C NEWSLETTER
        is news & views related to hepatitis C (alternative
        treatments and advances in medical treatment)
        It is FREE and sent to you via E-mail.
        To subscribe send blank e-mail to:
        HepC-subscribe@...
        http://www.topica.com/lists/HepC/prefs/info.html

        ~~~~~~~~~~~~~~~~

        Would you choose the cheapest brain surgeon?
        When it comes to your health, don't settle
        for less than the best. Get much more liver
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        Read the data. See the proof. Buy the best.

        Go to http://www.maximummilkthistle.com
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        Chuck Demastus
        Hepatitis C Newsletter
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        Kroon rebounds from liver transplant to win Inspiration Award

        By OTIS HART
        .c The Associated Press

        NEW YORK (AP) - Before Brittney Kroon could become an inspiration, she first needed a chance.

        The 6-foot-4 high school center from Wasilla, Alaska, looked like everybody's All-American on the outside - tall, talented, intelligent. But inside, Kroon was fighting a losing battle with liver disease.

        Without a transplant, her life on and off the basketball court was in constant doubt.

        ``A time of total confusion,'' her father, Larry Kroon said. ``You just have to give up and say, you can't orchestrate the future.''

        Kroon got that chance, and she's made the most of it. Kroon rebounded from surgery in 2002 to star at Seattle Pacific the past two seasons. After leading the Falcons to the Division II championship game in March, the junior was given the 2005 Inspiration Award at the Collegiate Women Sports Awards on Wednesday.

        ``It's one of those things where you're picked out of a lot of people like you, so it's an honor to be acknowledged,'' Kroon said.

        Kroon's comeback from autoimmune hepatitis didn't come without some heartbreaking drama.

        Her first shot at a cure came three years ago - and disappeared just as fast, turning what should have been one of the best nights of her life into one of the worst.

        After a tough three-point loss in the state championship game, Kroon's family returned to find three messages on the answering machine. The first one brought the news she had waited two years to hear: Doctors had located a donor.

        By the end of the third, she had already missed her chance.

        ``We got the first message saying the hospital had a match and that they needed a call back,'' Kroon said. ``The second message said they needed a call back before midnight.''

        That's when Kroon looked at the clock. She didn't need to hear the third message.

        ``We got a sinking feeling,'' Kroon said. ``To put it in words, it's hard. It's just one of those moments that you don't want to relive.''

        Kroon's beeper had gone off while she was playing in the game, and her parents never heard the cell phone ring over the roar of the crowd.

        ``That was probably the lowest point in my life at that point,'' Kroon said. ``Not only is your dream of a championship gone, but you just missed a second chance at life.''

        But the Kroons are a family of faith. Larry Kroon, a pastor, never gave up hope his daughter would get the operation she needed.

        He only had to wait five more days.

        On Good Friday, less than three weeks before Brittney Kroon's 18th birthday, she got the call. She had the transplant on March 31, 2002.

        ``Easter morning I walk in and she's got her new liver, and ... she's got a new life,'' Larry Kroon said. ``I have a hard time preaching Easter sermons now. It brings back too many memories.''

        If Kroon hadn't had the surgery before she turned 18 - when she was legally still a child - she probably would have had to wait two or three years for the operation.

        After surgery, Kroon had to rest three months before starting rehabilitation. That didn't stop Seattle Pacific coach Gordy Presnell from taking a chance on her.

        Good move.

        After spending most of her first year on the bench, Kroon led the nation in blocked shots in 2003-04 with 135. The Falcons finished the 2002-03 and 2003-04 regular seasons undefeated and reached the championship game last season before losing.

        Kroon's already in the all-time Division II top 10 in blocked shots and her next one will break the Great Northwest Athletic Conference's record.

        ``It was an absolute honor to be part of Brittney's life,'' Presnell said. ``Getting to coach her the last three years was one of my highlights in coaching.''

        Presnell moved on to Division I Boise State during the offseason after 18 years at Seattle Pacific, a promotion no doubt aided by Kroon's strong play in the middle.

        Kroon, of course, still has one more year as a Falcon. After that, she's hesitant to guess where she'll end up. Maybe basketball, maybe teaching. With a 3.74 GPA, she could probably do what ever she chooses.

        ``Brittney meets everything that comes at here without even stopping to think, 'Can I get through this?'' her father said. ``You get to the point where you think, 'I'd go anywhere with this kid.''


        ************************


        HCV Advocate E-blast

        The following items have been recently posted to www.hcvadvocate.org

        **July 2005 HCV Advocate

        *Report from DDW 2005 – Part 2 by Alan Franciscus, Editor-in-Chief

        *Seafood Safety: Avoiding Vibrio by Liz Highleyman

        *HealthWise: Medication: Reading the Fine Print by Lucinda K. Porter, RN, CCRC

        *Donor Registry

        *HCV Advocate Launches CME Site

        html: http://www.hcvadvocate.org/news/newsLetter/2005/advocate0705.html
        pdf: http://www.hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2005/advocate0705.pdf

        **Announcing a new series of HCSP Fact Sheets – Women and HCV

        Html: http://www.hcvadvocate.org/hepatitis/factsheets.asp#Women

        **Weekly News Review – for week ending July 25, 2005
        Html: http://www.hcvadvocate.org/news/newsRev/2005/NewsRev-106.html
        PDF: http://www.hcvadvocate.org/news/NewsUpdates_pdf/News_Review%202005/NewsRev-106.pdf

        **Top 10 English and Spanish Downloads
        Html: http://www.hcvadvocate.org/hepatitis/Top_Dwnloads.asp

        **Russian Easy C – Guide to HCV
        Pdf: http://www.hcvadvocate.org/Russian/EASY_Guide_rus.pdf

        Thanks!
        Alan

        Alan Franciscus
        Executive Director, Hepatitis C Support Project
        Editor-in-Chief, HCV Advocate Web site


        ***********************


        AVI BioPharma Submits IND for NEUGENE Antisense Drug Targeting Hepatitis C Virus


        PORTLAND, Ore.--(BUSINESS WIRE)----AVI BioPharma, Inc. (Nasdaq:AVII), today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its NEUGENE(R) antisense drug AVI-4065 targeting hepatitis C virus (HCV). The application provides the FDA with preclinical safety, toxicology and manufacturing data in support of clinical evaluation of AVI-4065 in humans who are chronically infected with HCV.

        "With a response rate of less than 50 percent for patients receiving existing treatments for the most common type of HCV infection, there remains a large unmet medical need for new and effective treatments," said Denis R. Burger, Ph.D., chief executive officer at AVI. "Our previous work in other viral research, including West Nile virus, has given us valuable insights on dosing, administration and pharmacokinetic data with which to begin this clinical program. That data, combined with the strong safety results we have seen in over 250 patients treated with NEUGENE drugs to date, greatly increases our confidence in the potential success of AVI-4065 for treating HCV."

        As proposed in the IND application, the initial multicenter Phase IB clinical trial will include up to 50 patients in three treatment groups: normal subjects and two groups of patients with chronic, active HCV, including patients who are newly diagnosed, and those who have failed the current standard of care, which is interferon and ribavirin. The study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 at two dosage levels for a specific period of time.

        Mark Holodniy, M.D., F.A.C.P., C.I.C., associate professor of medicine at Stanford University School of Medicine and director of the HIV Clinical Program and AIDS Research Center at Veterans Affairs Medical Center in Palo Alto, Calif., will serve as the principal investigator for this intended multicenter study.

        HCV is a single-stranded RNA virus known to undergo a high rate of mutation, which may help the virus develop resistance to many current and development-stage antiviral medications. Because HCV and other single-stranded RNA viruses have relatively simple genetic structures, they are attractive targets for AVI's NEUGENE antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time, after drug exposure.

        Another NEUGENE drug, AVI-4020, is currently being studied in a clinical trial of patients exhibiting presumptive neuroinvasive disease caused by West Nile virus. In addition, NEUGENE drugs are being tested against a variety of hemorrhagic, infectious and toxin-producing agents in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Walter Reed Army Institute of Research (WRAIR), and the Centers for Disease Control and Prevention (CDC).

        About Hepatitis C

        Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. According to the World Health Organization, approximately 170 million people worldwide are chronically infected with HCV. It is the most common chronic blood-borne infection in the developed world and the leading cause of liver transplants in the United States. The CDC estimates that approximately 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected. The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually in the United States from HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to 48 weeks of therapy with PEG-interferon alpha and ribavirin, is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S. In addition, this treatment has numerous side effects, some of them severe, which make it difficult for many patients to tolerate the recommended dosages and duration of treatment.

        About AVI BioPharma

        AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis and cancer. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, and Ebola virus. More information about AVI is available on the company's Web site at http://www.avibio.com

        "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.

        AVI BioPharma, Inc. Michael Hubbard, 503-227-0554 hubbard@... or Lippert/Heilshorn & Associates Inc. Investor Contacts Bruce Voss, 310-691-7100 bvoss@... or Jody Cain, 310-691-7100 jcain@... or Waggener Edstrom Bioscience Press Contact Wendy Carhart, 503-443-7000 wendyc@...


        ***********************


        Don't believe the childhood vaccine fearmongers
        http://www.townhall.com/columnists/GuestColumns/Fumento20050630.shtml



        Your free subscription is supported by today's sponsor:
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        http://alternativehopeforhepc.com
        The Alternative Program that works!
        Free Audio Tape & Info Packs available
        dianaroars@... or Call (877) 367-9875

        ********

        National Hepatitis C Coalition, Inc.
        http://nationalhepatitis-c.org

        ********

        The FAIR Foundation (Fair Allocations In Research)
        http://www.fairfoundation.org/

        ********

        To my subscribers:

        Here is a phone service I have been using for over 5 years.
        You can have this rate (3.9 cents per min.) for outbound
        long distance or get an 800 number (or both). The 800
        number is perfect for those with kids away at college and
        for truckers, salesmen, etc. International rates are VERY
        cheap, also. There is no monthly fee, all you pay is time
        used; if you make no calls, you get no bill. I get a
        commission if you sign up. If you already have a cheaper
        phone rate, please disregard. If not, what are you waiting
        for? Thanks.

        Chuck Demastus


        LONG DISTANCE - HOME OR BUSINESS!
        ONLY 3.9 cents per minute!
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        This email was sent to: alleypat@...

        EASY UNSUBSCRIBE click here: http://topica.com/u/?bUrH4z.bOtdZm.YWxsZXlw
        Or send an email to: HepC-unsubscribe@...

        For Topica's complete suite of email marketing solutions visit:
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        [Non-text portions of this message have been removed]
      • avansi7465
        Thanks for the info. Hope the job situation is going well. Anne ... From: Shshonee (Alley) Sent: Jul 2, 2005 11:04 AM To:
        Message 3 of 4 , Jul 2, 2005
        • 0 Attachment
          Thanks for the info. Hope the job situation is going well. Anne
          -----Original Message-----
          From: "Shshonee (Alley)" <shshonee@...>
          Sent: Jul 2, 2005 11:04 AM
          To: GIWorld-Hepatitis@yahoogroups.com,
          Happy Heppers <happyheppers@yahoogroups.com>
          Subject: [GIWorld-Hepatitis] Fw: HepC Newsletter


          HEPATITIS C NEWSLETTER
          is news & views related to hepatitis C (alternative
          treatments and advances in medical treatment)
          It is FREE and sent to you via E-mail.
          To subscribe send blank e-mail to:
          HepC-subscribe@...
          http://www.topica.com/lists/HepC/prefs/info.html

          ~~~~~~~~~~~~~~~~

          Would you choose the cheapest brain surgeon?
          When it comes to your health, don't settle
          for less than the best. Get much more liver
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          Read the data. See the proof. Buy the best.

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          Chuck Demastus
          Hepatitis C Newsletter
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          Kroon rebounds from liver transplant to win Inspiration Award

          By OTIS HART
          .c The Associated Press

          NEW YORK (AP) - Before Brittney Kroon could become an inspiration, she first needed a chance.

          The 6-foot-4 high school center from Wasilla, Alaska, looked like everybody's All-American on the outside - tall, talented, intelligent. But inside, Kroon was fighting a losing battle with liver disease.

          Without a transplant, her life on and off the basketball court was in constant doubt.

          ``A time of total confusion,'' her father, Larry Kroon said. ``You just have to give up and say, you can't orchestrate the future.''

          Kroon got that chance, and she's made the most of it. Kroon rebounded from surgery in 2002 to star at Seattle Pacific the past two seasons. After leading the Falcons to the Division II championship game in March, the junior was given the 2005 Inspiration Award at the Collegiate Women Sports Awards on Wednesday.

          ``It's one of those things where you're picked out of a lot of people like you, so it's an honor to be acknowledged,'' Kroon said.

          Kroon's comeback from autoimmune hepatitis didn't come without some heartbreaking drama.

          Her first shot at a cure came three years ago - and disappeared just as fast, turning what should have been one of the best nights of her life into one of the worst.

          After a tough three-point loss in the state championship game, Kroon's family returned to find three messages on the answering machine. The first one brought the news she had waited two years to hear: Doctors had located a donor.

          By the end of the third, she had already missed her chance.

          ``We got the first message saying the hospital had a match and that they needed a call back,'' Kroon said. ``The second message said they needed a call back before midnight.''

          That's when Kroon looked at the clock. She didn't need to hear the third message.

          ``We got a sinking feeling,'' Kroon said. ``To put it in words, it's hard. It's just one of those moments that you don't want to relive.''

          Kroon's beeper had gone off while she was playing in the game, and her parents never heard the cell phone ring over the roar of the crowd.

          ``That was probably the lowest point in my life at that point,'' Kroon said. ``Not only is your dream of a championship gone, but you just missed a second chance at life.''

          But the Kroons are a family of faith. Larry Kroon, a pastor, never gave up hope his daughter would get the operation she needed.

          He only had to wait five more days.

          On Good Friday, less than three weeks before Brittney Kroon's 18th birthday, she got the call. She had the transplant on March 31, 2002.

          ``Easter morning I walk in and she's got her new liver, and ... she's got a new life,'' Larry Kroon said. ``I have a hard time preaching Easter sermons now. It brings back too many memories.''

          If Kroon hadn't had the surgery before she turned 18 - when she was legally still a child - she probably would have had to wait two or three years for the operation.

          After surgery, Kroon had to rest three months before starting rehabilitation. That didn't stop Seattle Pacific coach Gordy Presnell from taking a chance on her.

          Good move.

          After spending most of her first year on the bench, Kroon led the nation in blocked shots in 2003-04 with 135. The Falcons finished the 2002-03 and 2003-04 regular seasons undefeated and reached the championship game last season before losing.

          Kroon's already in the all-time Division II top 10 in blocked shots and her next one will break the Great Northwest Athletic Conference's record.

          ``It was an absolute honor to be part of Brittney's life,'' Presnell said. ``Getting to coach her the last three years was one of my highlights in coaching.''

          Presnell moved on to Division I Boise State during the offseason after 18 years at Seattle Pacific, a promotion no doubt aided by Kroon's strong play in the middle.

          Kroon, of course, still has one more year as a Falcon. After that, she's hesitant to guess where she'll end up. Maybe basketball, maybe teaching. With a 3.74 GPA, she could probably do what ever she chooses.

          ``Brittney meets everything that comes at here without even stopping to think, 'Can I get through this?'' her father said. ``You get to the point where you think, 'I'd go anywhere with this kid.''


          ************************


          HCV Advocate E-blast

          The following items have been recently posted to www.hcvadvocate.org

          **July 2005 HCV Advocate

          *Report from DDW 2005 ? Part 2 by Alan Franciscus, Editor-in-Chief

          *Seafood Safety: Avoiding Vibrio by Liz Highleyman

          *HealthWise: Medication: Reading the Fine Print by Lucinda K. Porter, RN, CCRC

          *Donor Registry

          *HCV Advocate Launches CME Site

          html: http://www.hcvadvocate.org/news/newsLetter/2005/advocate0705.html
          pdf: http://www.hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2005/advocate0705.pdf

          **Announcing a new series of HCSP Fact Sheets ? Women and HCV

          Html: http://www.hcvadvocate.org/hepatitis/factsheets.asp#Women

          **Weekly News Review ? for week ending July 25, 2005
          Html: http://www.hcvadvocate.org/news/newsRev/2005/NewsRev-106.html
          PDF: http://www.hcvadvocate.org/news/NewsUpdates_pdf/News_Review%202005/NewsRev-106.pdf

          **Top 10 English and Spanish Downloads
          Html: http://www.hcvadvocate.org/hepatitis/Top_Dwnloads.asp

          **Russian Easy C ? Guide to HCV
          Pdf: http://www.hcvadvocate.org/Russian/EASY_Guide_rus.pdf

          Thanks!
          Alan

          Alan Franciscus
          Executive Director, Hepatitis C Support Project
          Editor-in-Chief, HCV Advocate Web site


          ***********************


          AVI BioPharma Submits IND for NEUGENE Antisense Drug Targeting Hepatitis C Virus


          PORTLAND, Ore.--(BUSINESS WIRE)----AVI BioPharma, Inc. (Nasdaq:AVII), today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its NEUGENE(R) antisense drug AVI-4065 targeting hepatitis C virus (HCV). The application provides the FDA with preclinical safety, toxicology and manufacturing data in support of clinical evaluation of AVI-4065 in humans who are chronically infected with HCV.

          "With a response rate of less than 50 percent for patients receiving existing treatments for the most common type of HCV infection, there remains a large unmet medical need for new and effective treatments," said Denis R. Burger, Ph.D., chief executive officer at AVI. "Our previous work in other viral research, including West Nile virus, has given us valuable insights on dosing, administration and pharmacokinetic data with which to begin this clinical program. That data, combined with the strong safety results we have seen in over 250 patients treated with NEUGENE drugs to date, greatly increases our confidence in the potential success of AVI-4065 for treating HCV."

          As proposed in the IND application, the initial multicenter Phase IB clinical trial will include up to 50 patients in three treatment groups: normal subjects and two groups of patients with chronic, active HCV, including patients who are newly diagnosed, and those who have failed the current standard of care, which is interferon and ribavirin. The study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 at two dosage levels for a specific period of time.

          Mark Holodniy, M.D., F.A.C.P., C.I.C., associate professor of medicine at Stanford University School of Medicine and director of the HIV Clinical Program and AIDS Research Center at Veterans Affairs Medical Center in Palo Alto, Calif., will serve as the principal investigator for this intended multicenter study.

          HCV is a single-stranded RNA virus known to undergo a high rate of mutation, which may help the virus develop resistance to many current and development-stage antiviral medications. Because HCV and other single-stranded RNA viruses have relatively simple genetic structures, they are attractive targets for AVI's NEUGENE antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time, after drug exposure.

          Another NEUGENE drug, AVI-4020, is currently being studied in a clinical trial of patients exhibiting presumptive neuroinvasive disease caused by West Nile virus. In addition, NEUGENE drugs are being tested against a variety of hemorrhagic, infectious and toxin-producing agents in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Walter Reed Army Institute of Research (WRAIR), and the Centers for Disease Control and Prevention (CDC).

          About Hepatitis C

          Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. According to the World Health Organization, approximately 170 million people worldwide are chronically infected with HCV. It is the most common chronic blood-borne infection in the developed world and the leading cause of liver transplants in the United States. The CDC estimates that approximately 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected. The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually in the United States from HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to 48 weeks of therapy with PEG-interferon alpha and ribavirin, is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S. In addition, this treatment has numerous side effects, some of them severe, which make it difficult for many patients to tolerate the recommended dosages and duration of treatment.

          About AVI BioPharma

          AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis and cancer. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, and Ebola virus. More information about AVI is available on the company's Web site at http://www.avibio.com

          "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.

          AVI BioPharma, Inc. Michael Hubbard, 503-227-0554 hubbard@... or Lippert/Heilshorn & Associates Inc. Investor Contacts Bruce Voss, 310-691-7100 bvoss@... or Jody Cain, 310-691-7100 jcain@... or Waggener Edstrom Bioscience Press Contact Wendy Carhart, 503-443-7000 wendyc@...


          ***********************


          Don't believe the childhood vaccine fearmongers
          http://www.townhall.com/columnists/GuestColumns/Fumento20050630.shtml



          Your free subscription is supported by today's sponsor:
          -------------------------------------------------------------------
          Get $1000.00 Overnight! Fast and Easy!
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          -------------------------------------------------------------------
          Alternative Hope for HepC
          http://alternativehopeforhepc.com
          The Alternative Program that works!
          Free Audio Tape & Info Packs available
          dianaroars@... or Call (877) 367-9875

          ********

          National Hepatitis C Coalition, Inc.
          http://nationalhepatitis-c.org

          ********

          The FAIR Foundation (Fair Allocations In Research)
          http://www.fairfoundation.org/

          ********

          To my subscribers:

          Here is a phone service I have been using for over 5 years.
          You can have this rate (3.9 cents per min.) for outbound
          long distance or get an 800 number (or both). The 800
          number is perfect for those with kids away at college and
          for truckers, salesmen, etc. International rates are VERY
          cheap, also. There is no monthly fee, all you pay is time
          used; if you make no calls, you get no bill. I get a
          commission if you sign up. If you already have a cheaper
          phone rate, please disregard. If not, what are you waiting
          for? Thanks.

          Chuck Demastus


          LONG DISTANCE - HOME OR BUSINESS!
          ONLY 3.9 cents per minute!
          HAVE YOUR OWN 800# - HOME OR BUSINESS
          NO SET-UP FEES - NO MONTHLY FEES - NO SURCHARGES
          FOR SERVICE 1-800-360-8918 - RD# 205
          http://www.800ld.com/205/
          Also UNLIMITED INTERNET ACCESS
          ONLY $14.95 a month--^^---------------------------------------------------------------
          This email was sent to: alleypat@...

          EASY UNSUBSCRIBE click here: http://topica.com/u/?bUrH4z.bOtdZm.YWxsZXlw
          Or send an email to: HepC-unsubscribe@...

          For Topica's complete suite of email marketing solutions visit:
          http://www.topica.com/?p=TEXFOOTER
          --^^---------------------------------------------------------------

          [Non-text portions of this message have been removed]



          Welcome to GIHepWorld

          Post message: GIWorld-Hepatitis@yahoogroups.com
          Subscribe: GIWorld-Hepatitis-subscribe@yahoogroups.com
          Unsubscribe: GIWorld-Hepatitis-unsubscribe@yahoogroups.com
          List owner: GIWorld-Hepatitis-owner@yahoogroups.com
          URL to this page: http://groups.yahoo.com/group/GIWorld-Hepatitis

          Yahoo! Groups Links
        • Shshonee (Alley)
          ... From: Charles Demastus To: HepC@topica.com Sent: Sunday, July 31, 2005 6:04 PM Subject: HepC Newsletter HEPATITIS C NEWSLETTER is news & views related to
          Message 4 of 4 , Aug 3, 2005
          • 0 Attachment
            ----- Original Message -----
            From: Charles Demastus
            To: HepC@...
            Sent: Sunday, July 31, 2005 6:04 PM
            Subject: HepC Newsletter


            HEPATITIS C NEWSLETTER
            is news & views related to hepatitis C (alternative
            treatments and advances in medical treatment)
            It is FREE and sent to you via E-mail.
            To subscribe send blank e-mail to:
            HepC-subscribe@...
            http://www.topica.com/lists/HepC/prefs/info.html

            ~~~~~~~~~~~~~~~~

            Would you choose the cheapest brain surgeon?
            When it comes to your health, don't settle
            for less than the best. Get much more liver
            protection with MAXIMUM MILK THISTLE?

            Clinically proven far superior to
            any other milk thistle product.

            Read the data. See the proof. Buy the best.

            Go to http://www.maximummilkthistle.com
            I personally use and recommend it.

            Chuck Demastus
            Hepatitis C Newsletter
            Your free subscription is supported by today's sponsor:
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            NATAP http://natap.org/
            _______________________________________________

            Roche Launches New Campaign to Educate Consumers About Hepatitis C

            This is press release issued by Roche. --Effort Encourages Patients to Speak with Physicians About Available Therapies--

            NUTLEY, New Jersey (July 26, 2005) - Roche announced today the launch of a major new campaign to motivate hepatitis C patients who have been diagnosed with the disease to take the critical step of discussing prescription treatment with a liver specialist or hepatitis C-treating physician.

            Often called a “silent disease,” hepatitis C usually reveals no specific signs or symptoms and remains rarely diagnosed until its chronic stages when it has already caused severe liver disease. In fact, when left untreated, hepatitis C may lead to cirrhosis, liver cancer and even death. According to the Centers for Disease Control and Prevention (CDC), there are approximately four million Americans currently infected with hepatitis C, yet less than 30 percent, or about one million people, have actually been diagnosed with the disease. Additionally, almost 60 percent of those one million diagnosed patients have never been treated.

            “It is critical for hepatitis C patients to be educated about the potential harmful effects of allowing the disease to go untreated,” said Dr. Paul Pockros, Scripps Clinic, San Diego, Calif. “Anyone who has been diagnosed with hepatitis C should speak to a physician to determine whether treatment is medically appropriate.” The centerpiece of the campaign is a print advertisement featuring a man with a severely bruised face and a tagline that reads, “If Hep C was attacking your face instead of your liver, you'd do something about it.” The ad, which debuts in major national and local daily newspapers today, will begin to appear in national newsmagazines in August and in transit media in September.
            There are three versions of the ad, depicting a Caucasian, an African-American, and a Latino.

            “As an advocate for those living with hepatitis C, I have seen firsthand the need for increased awareness of the disease. This campaign is an important addition to our own outreach efforts,” said Andi Thomas, Executive Director, Hep-C Alert. “Patients should know their options and be proactive in the management of their disease, and this campaign helps achieve those patient education objectives.”

            The campaign directs consumers to a new Web site,www.hepCfight.com, and to a telephone information line (866-HepCSource), which both serve as patient resources for information about the disease. “As the market leader in the treatment of hepatitis C, Roche is undertaking this new disease awareness campaign to communicate the potential harmful effects of hepatitis C on the liver in a way that consumers can easily recognize and understand,” said Gary Ziezula, Vice President, Commercial Operations, Roche.

            “Our hope is that the ad will motivate those diagnosed with hepatitis C to make an appointment and speak to their physicians to determine if treatment is the next best step.”

            More About Chronic Hepatitis C

            Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants.

            An estimated 2.7 million Americans are chronically infected with the hepatitis C virus (HCV), with 35,000 to 180,000 new infections each year. The CDC estimates that hepatitis C is responsible for eight to ten thousand deaths per year and could increase to 38,000 by the year 2010, surpassing annual HIV/AIDS deaths.

            Treatment of Hepatitis C

            The combination therapy of pegylated interferon and ribavirin is the current standard of care for hepatitis C. Clinical trials have shown that this combination treatment makes the hepatitis C virus undetectable in more than half of the patients who are treated. Response to treatment may vary based on individual factors, genotype, viral load and race. There is no vaccine available for hepatitis C. Combination therapy results in better treatment responses than monotherapy, but the highest response rates have been achieved with pegylated interferon in combination with ribavirin. Currently, the best indicator of effective treatment is an SVR, defined by the absence of detectable HCV RNA in the serum as shown by a qualitative HCV RNA assay with lower limit of detection of 50 IU/mL or less at 24 weeks after the end of treatment. The following are some of the most common side effects associated with pegylated interferon plus ribavirin therapy: flu-like symptoms, including fever, chills, and muscle aches; fatigue; upset stomach, nausea/vomiting; loss of appetite; difficulty in controlling blood sugar

            levels (which may lead to diabetes); skin reactions (such as rash, dry or itchy skin, temporary hair loss, or redness and swelling at the site of injection); temporary hair thinning; and trouble sleeping. Possible serious side effects include mental health problems such as depression, blood problems, infections, and problems with the lungs, eyes, immune system, and heart. Healthcare providers may treat these side effects, change the amount of medication, or stop treatment.

            About Roche - More Than a Century in the U.S. and the World

            Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

            Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January toFortunemagazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global:www.roche.com and U.S.:www.roche.us).


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            NATAP http://natap.org/
            _______________________________________________


            24 vs 48 weeks Pegasys/RBV in HCV Genotype 2/3 Coinfection: does this study answer the question

            Reported by Jules Levin
            Intl AIDS Society Conference
            Rio de Janeiro
            July 24-27, 2005

            An Italian research group (Puoti, Zanini et al, Master coinfection study group; Poster MoPpLB0103, Rio) studied whether 24 or 48 weeks therapy (Pegays+ribavirin) showed better viral outcomes for HCV/HIV patients with genotype 2/3. As it turned out 92-100% of study patients had genotype 3. The incidence of relapses in patients who were HCV RNA negative at end of treatment was the main outcome compared between the two groups.

            The authors concluded that these study results “suggest that the optimal duration of therapy in coinfected patients with genotypes 2/3 is at least 48 weeks”, because the study observed a higher relapse rate among patients who were HCV negative after 24 weeks therapy compared to those who were HCV negative after 48 weeks therapy.

            Does this study answer the question?
            I don't think this study was conducted in a manner to provide a conclusive answer to the question. To better address the question therapy and patients should be stratified by baseline viral load, the presence of cirrhosis, and perhaps other characteristics. That is, if you select patients with all the characteristics that would lend themselves to achieving an SVR with only 24 weeks therapy, that would be a better patient population in which to study this question. Such characteristics would include: patients with >500 CD4s and <50 copies/ml, with reconstituted immune systems; no fatty liver; no cirrhosis, early stage HCV disease; low HCV viral load; full adherence; use of EPO; undetectable HCV RNA by week 4 or 8. Perhaps these patients could achieve better outcomes with shorter than 48 weeks therapy. Even with these considerations it is reasonable to think that in HIV at least 48 weeks therapy is necessary to optimize response rates.

            BACKGROUND: In HCV monoinfection, study results show the 24 weeks therapy with peginterferon plus ribavirin may be adequate duration of therapy for patients with genotype 2/3. The Hadziyannis study of Pegasys plus 800mg daily ribavirin found 73-78% SVR rates for genotype 2/3 for 24 or 48 weeks therapy regardless of viral load levels at baseline of weight. This study set a standard for 24 weeks therapy with peginterferon plus RBV in genotypes 2/3 who are HCV monoinfected. However, this study did not examine the effects of adherence on outcomes of 24 vs 48 weeks therapy. It is possible that high adherence levels (80-100%) would have resulted in a better SVR rate with 48 weeks therapy. Dose reductions of peginterferon or ribavirin were likely to have occurred more often for patients receiving 48 weeks therapy. So, you could make a case that a patients with 100% adherence and no dose reductions would achieve better SVR rates with 48 weeks therapy. But, perhaps 24 weeks might be adequate for most patients.

            A study published in the NEJM (June 2005) found that for HCV monoinfected genotype 2/3 patients with undetectable HCV RNA after 4 weeks of peginterferon alfa-2b plus ribavirin , 12 weeks of therapy was as effective as 24 weeks of therapy in terms of SVR rates. But there was a slight suggestion that the risk for relapse could be a bit higher in the 12-week group. Here is link to study article:
            Peginterferon Alfa-2b and Ribavirin for 12 vs. 24 Weeks in HCV ...
            www.natap.org/2005/HCV/062305_01.htm

            Another consideration is long-term outcomes over the course of many years. Although SVR rates appear the same with 24 or 48 weeks duration of therapy for patients in certain categories, will this hold up 10-20 years in the future?

            BACK TO ITALIAN COINFECTION STUDY
            36 patients received 48 weeks of Pegasys + ribavirin therapy (800-1200 mg/daily dosed by weight). Only 2 (11%) of the 19 patients concluding the 48-week treatment period relapsed. Per-protocol analysis showed a significantly lower relapse rate in the patient group receiving 48 weeks therapy compared to those receiving only 24 weeks therapy (11% vs 40%, p=0.04), “that was not observed in the ITT analysis 53% vs 40%” (stated in the program book).

            STUDY AIM: to optimize duration of treatment for chronic hepatitis C in persons infected by HIV and HCV genotype 2 or 3.
            STUDY DESIGN: Randomized prospective, open, controlled trial,
            METHODS: The study enrolled patients on stable ART >6 weeks, CD4 count >200 & HIV RNA <10,000 c/ml, or ART naïve with CD4 count >300. All patients received Pegasys at 180 mcg once a week by subcutaneous injection in combination with ribavirin 10.6-13 mg/kg/day for 28 weeks. Ribavirin dose was based on weight: <65 kg, 800 mg daily; 66-85 kg, 1000 mg daily; >85 kg, 1200 mg daily.

            All patients showing negative HCV RNA at 24 weeks were randomized at the 28th week to: stop treatment or continue treatment for an additional 20 weeks for a total of 48 weeks therapy. Of the128 coinfected patients who were enrolled in the study 74 were HCV PCR negative after 24 weeks of therapy.

            The incidence of relapses in patients who were HCV RNA negative at end of treatment was the main outcome compared between the two groups. 128 patients were enrolled. 46 patients (36%) stopped treatment before 24 weeks: 20 (16%) because of adverse events and 26 (20%) for intolerance. 30 of these 46 (65%) showed HCV RNA negativity during treatment, but 14 out of 30 (47%) relapsed after stopping treatment. 8 out of 82 patients (10%) did not show negative HCV RNA at the end of the first 24 weeks of treatment. THEN, 74 patients were randomized: 38 to stop treatment and 36 to continue treatment for a total of 48 weeks. 15 (40%) of the patients who stopped at 24 weeks relapsed after treatment withdrawal.

            17 patients from the group that continued treatment prematurely stopped therapy: 4 for serious adverse event (2 relapsed) and 13 for intolerance (11 relapsed). Only 2 (11%) of the 19 patients concluding the 48-week treatment period relapsed.

            BASELINE CHARACTERISTICS
            28-week treatment 48-wk treatment
            n=38 n=36
            males 79% 83%
            Age 38 yrs 39.5 yrs
            Median CD4 count 529 460
            HIV <50 c/ml 55% 50%
            On ART 68% 67%
            HCV geno 3 100% 92%
            HCV RNA>
            800,000 IU/mL 45% 57%
            HCV negative
            at wk 4 53% 52%
            1-log drop in
            HCV RNA at Wk 4 97% 84%
            HCV RNA neg
            at wk 12 94% 89%
            Mean ALT 112 136
            Cirrhosis 53% 42%
            (Metavir fibrosis score 3-4)

            ADVERSE EVENTS

            Serious adverse events were reported in 40 (31%) of the 128 patients in weeks 0-24, and 8 (22%) of patients in weeks 28-48 of treatment. The overall SAE-related treatment withdrawal rate was 18%: 12% (n=16) of the 128 patients during weeks 0-24, and 8% (n=3) in the 36 patients during weeks 28-48. This shows patients probably got used to the side effects or were better able to tolerate them after a while. Or the patients continuing therapy had more incentive to continue.

            During weeks 0-24 (n=128) there were 8 grade 3 neuropsyciatric events (7/8) cases resolved with peginterferon and/or RBV dose reduction, and 5 grade 4 cases. During weeks 28-48 there was 1 grade 3 and 1 grade 4 neuropsychiatric event. The grade 3 event resolved with peginterferon and/or RBV dose reduction.

            ANEMIA: There were 6 cases of grade 3 anemia (all resolved with peginterferon and/orRBV dose reduction) and 1 case of grade 4 anemia during weeks 0-24. During weeks 28-48 there were 2 cases of grade 2 anemia (resolves with peginterferon and/or RBV dose reduction) and 1 case of grade 4 anemia.

            NEUTROPENIA: there were 10 cases of grade 3 neutropenia (all resoleved with peginterferon and/or RBV dose reduction) and 1 case of grade 4 during weeks 0-24. During weeks 28-48 there were 2 cases of grade 3 neuropenia (all resolved with peg and/or RBV dose reduction) and no grade 4 cases.

            THROMBOCYTOPENIA: there was 1 case of grade 3 (resolved with peg and/or RBV dose reduction) and 2 cases of grade 4. There were no cases during weeks 28-48.

            There was 1 case of neuropathy reported, grade 4 during weeks 28-48.

            This study apparently did not use adjunctive therapy such as EPO for anemia or neutropenia.


            ************************


            NATAP - http://www.natap.org

            European Union's CHMP Adopts Positive Opinion for Shorter Course of PEGINTRON(R) and REBETOL(R) Combination Therapy for Certain Hepatitis C Patients with Genotype 1 and Low Viral Load (NOT FOR COINFECTION)

            This press release was issued by Schering-Plough.

            KENILWORTH, N.J., July 29 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of revised dosing instructions which allow a shorter, 24-week course of weight-based PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800 - 1,200 mg) daily combination therapy among a subgroup of patients with hepatitis C virus (HCV) genotype 1 infection and low viral load (< 600,000 IU/ml). A shorter 24-week course of therapy can be considered for these patients who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week 4 of treatment that is maintained through week 24. A 92 percent sustained virologic response was achieved with 24 weeks of treatment among the 41 percent of patients who met the criteria for early response.

            PEGINTRON and REBETOL combination therapy was previously approved in the EU for a 48-week course of therapy for all patients with genotype 1 who exhibit virological response at week 12. Approval of this shorter PEGINTRON and REBETOL combination treatment regimen cuts by half the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load. This is the only treatment regimen approved in the European Union (EU) for a 24-week course of therapy in certain genotype 1 patients.

            The CHMP recommendation serves as the basis for a European Commission approval of this labeling change. A Commission Decision will result in Marketing Authorization with unified labeling that will be valid in the current EU 25 member states as well as in Iceland and Norway.

            "The important results of this clinical study with PEGINTRON and REBETOL reflect the ongoing efforts of Schering-Plough to define optimal dose and treatment schedules for specific HCV patient groups," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.

            Study Results

            The recommended labeling change for PEGINTRON and REBETOL is based on results of a clinical study involving 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with weight-based PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800 - 1,400 mg daily); only two patients weighing >105 kg received the 1,400 mg dose). In the study, 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week 4 and week 24 of therapy. Patients in this subgroup achieved a 92 percent (89/97) rate of sustained virological response (SVR). The high sustained response rate in this group of patients was identified in an interim analysis and prospectively confirmed.

            Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall, varying by geography. For patients with HCV genotypes 2 or 3, the EU labeling for PEGINTRON recommends that all patients be treated for 24 weeks. Patients infected with HCV genotype 4 are considered harder to treat and generally 48 weeks of therapy is recommended.

            About PEGINTRON and REBETOL Combination Therapy

            PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the European Union (EU) in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg/once weekly plus REBETOL 800-1,200 mg daily, adjusted to body weight. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.

            PEGINTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity.

            Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.

            Important Information Regarding U.S. Labeling for PEG-INTRON and REBETOL

            WARNING

            Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life- threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.

            Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.

            REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.

            PEG-INTRON
            There are no new adverse events specific to PEG-INTRON as compared to INTRONÂ A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.

            Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.

            PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).

            The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEG-INTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

            In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.

            REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

            Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is www.schering-plough.com.


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            NATAP http://natap.org/
            _______________________________________________


            Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in HBV

            This press release was issued by Idenix.

            * Idenix and Novartis anticipate first regulatory filing by the end of 2005

            * Complete GLOBE results to be submitted for presentation at American Association for the Study of Liver Diseases meeting in November 2005

            CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) and Novartis Pharma AG announced today that the phase III GLOBE registration trial for telbivudine successfully reached its primary, composite efficacy endpoint of therapeutic response at one year in chronic hepatitis B patients. This endpoint, which was designed to assess if telbivudine was at least as effective as lamivudine, evaluated the combination of viral suppression (serum HBV DNA suppression below 100,000 copies/mL) coupled with either improved liver function (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg).

            The largest hepatitis B registration trial to date, GLOBE enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: telbivudine 600 mg or lamivudine 100 mg.

            The one-year analysis of this trial will be the primary data used for preparing the marketing registration applications. Idenix and Novartis plan to file with the U.S. Food and Drug Administration (FDA) by the end of 2005 for marketing approval of telbivudine for the treatment of chronic hepatitis B. Worldwide marketing filings, including the filing that will be submitted to the European Medicines Agency (EMEA), are expected in the first quarter of 2006. Idenix and Novartis are co-developing telbivudine.

            The World Health Organization (WHO) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus (HBV). Current treatment options are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating chronic hepatitis B.

            "We are very pleased that telbivudine met the primary endpoint in the phase III GLOBE study and may provide an important new therapeutic option for patients with chronic hepatitis B," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "Bringing our first clinical candidate through this stage of development is a major milestone for Idenix, particularly given the large international scope of the GLOBE study."

            The companies anticipate that complete data from the GLOBE study will be submitted for presentation to the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, California, November 11-15, 2005.

            More About Telbivudine

            Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis. This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with telbivudine treatment.

            The GLOBE study results continue to support a favorable overall safety profile for telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date. The most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were equally common for telbivudine (14% and 12 %, respectively) and lamivudine (13% and 10% respectively).

            An additional phase III trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.

            About Hepatitis B

            Chronic Hepatitis B is caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The WHO estimates that annually over 50 million people become infected with HBV and that more than one million individuals die from HBV-related chronic liver disease.

            Idenix/Novartis Collaboration

            Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003. The collaboration arrangement further provides that Novartis and Idenix will co- promote in the United States, France, Germany, Italy, Spain and the UK those product candidates Novartis has licensed, including telbivudine and valtorcitabine, that are approved for marketing. Novartis holds the exclusive license to telbivudine and valtorcitabine in the rest of the world.

            The collaboration also provides Novartis with an exclusive option to license and collaborate with Idenix in the development and commercialization of other product candidates in Idenix's portfolio, including valopicitabine (NM283), a direct antiviral hepatitis C product candidate.

            About Idenix

            Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com

            Idenix Pharmaceuticals Reports Second Quarter and Six Month Financial Results

            CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2005.

            For the second quarter ended June 30, 2005, Idenix reported total revenues of $16.1 million, compared with total revenues of $42.8 million in the second quarter of 2004. Total revenues include reimbursement by Novartis of expenses incurred by Idenix in connection with the development of telbivudine and valtorcitabine, Idenix's drug candidates for the treatment of hepatitis B, and amortization of the up-front fees paid to Idenix in May 2003 when Novartis licensed Idenix's hepatitis B drug candidates. In the 2004 quarter, total revenues also included a $25 million milestone payment received from Novartis related to the successful completion by Idenix of a phase I clinical trial of valopicitabine, or NM283, Idenix's lead drug candidate for the treatment of hepatitis C. Idenix reported a net loss of $13.4 million or a loss of $0.28 per diluted share for the second quarter ended June 30, 2005, compared to net income of $21.0 million, or $0.53 per diluted share for the second quarter ended June 30, 2004.

            For the six months ended June 30, 2005, Idenix reported total revenues of $31.0 million, compared with total revenues of $59.5 million for the six months ended June 30, 2004. The company reported a net loss of $22.7 million, or a loss of $0.47 per diluted share for the six months ended June 30, 2005, compared with net income of $15.1 million, or $0.39 per diluted share for the six months ended June 30, 2004.

            The profitability experienced by the company for the quarter ended and six months ended June 30, 2004 was due to the recognition of the $25 million milestone payment received from Novartis during the second quarter of 2004. At June 30, 2005, Idenix's cash, cash equivalents and marketable securities totaled $129.1 million.

            Business Highlights

            "We have achieved significant milestones in our hepatitis B and hepatitis C development programs over the last three months," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "Most significantly, as we reported in a separate press release today, the initial data indicate that telbivudine has met the primary efficacy endpoint in the 1,370 patient phase III GLOBE study. We anticipate finalizing the GLOBE data set shortly and plan to submit the complete data as a late-breaker abstract to the American Association for the Study of Liver Diseases for presentation at its annual meeting in November."

            Additionally, the following accomplishments were realized by Idenix over the last three months:

            * The company presented 2-year phase IIb telbivudine data at the 2005 Digestive Disease Week annual meeting that further demonstrated the correlation between early and profound viral suppression and markers of improved clinical outcomes. YOU CAN READ TELBIVUDINE STUDY RESULTS ON NATAP WEBSITE.

            * The company completed enrollment (with 190 patients) of the phase IIb clinical trial of valopicitabine in treatment refractory patients. This clinical trial, which has been extended to 48 weeks, is a head-to-head trial comparing the combination of valopicitabine plus Pegasys® to ribavirin plus Pegasys® in hepatitis C genotype 1 patients who have previously failed at least 3 months of treatment with pegylated interferon plus ribavirin, the current standard therapy. Idenix expects to report preliminary clinical data from this phase IIb trial in the fall of 2005 and currently anticipates initiating a phase III clinical trial in this patient population in the first half of 2006.

            * The company initiated the phase IIb trial of valopicitabine in treatment-naive hepatitis C genotype 1 patients at clinical sites in late July. This trial is designed to quantitatively assess the antiviral dose-response relationship for valopicitabine in treatment regimens comprising combinations of Pegasys® with various valopicitabine dosing regimens. The goal of this study is to identify the optimal combination regimen (valopicitabine plus pegylated interferon) for further study in phase III trials in treatment naïve patients.

            2005 Expectations

            Based on the expected timing and cost of current and anticipated clinical trials and the planned growth of Idenix's commercial operations, the company currently expects its net use of cash to be between $70 million and $80 million in 2005, which would result in 2005 year-end cash, cash equivalents and marketable securities of between $77 million and $87 million.



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