Fw: HepC Newsletter
----- Original Message -----
From: Charles Demastus
Sent: Sunday, July 31, 2005 6:04 PM
Subject: HepC Newsletter
HEPATITIS C NEWSLETTER
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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).
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 ...
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.
28-week treatment 48-wk treatment
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%
800,000 IU/mL 45% 57%
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)
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.
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
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.
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.
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 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.
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.
"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.
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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Alternative Hope for HepC
The Alternative Program that works!
Free Audio Tape & Info Packs available
dianaroars@... or Call (877) 367-9875
National Hepatitis C Coalition, Inc.
The FAIR Foundation (Fair Allocations In Research)
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
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
Also UNLIMITED INTERNET ACCESS
ONLY $14.95 a month--^^---------------------------------------------------------------
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