Dear Dr. Misra:
First and foremost, thanks for your valuable contributions to this "new"
resource for HCV patients!
Secondly, there has been no mention of treatment options for
"non-responders." Can you comment on this please?
Does age (50+), sex (F), hormones (post-menopausal), HCV origin (blood
transfusion), or genotype 1(b) effect success rates?
Was naive at onset of "combo" treatment (w/daily injects); 6+ months later
found to be a non-responder; followed by 3+ months washout period.
Next, daily high dosage Infergen (injects), but at 3 months my blood counts
fell too low (esp. white) and treatment was discontinued.
Now into my second washout cycle "desperately" searching for a clinical
trial and/or a randomized study of PEG solo or PEG combo based in California
which will accept non-responders. Any suggestions please?
Thanks again, CynMor
From: Doc <gidoc@...
To: GIHepatitis <GIWorld-Hepatitis@onelist.com
Date: Monday, January 10, 2000 11:22 AM
Subject: [GIWorld-Hepatitis] Predictors of response to treatment of HCV-CH
>From: "Doc" <gidoc@...>
>Predictors of response to treatment of HCV-CH
>In clinical trials of Ch Hep C, sustained response to treatment is defined
>as absence of HCV RNA for more than 6 months following therapy.
>Responsiveness of the virus to therapy is dependent upon host and viral
>factors, including genotype, quantity of circulating HCV, presence of
>hepatic fibrosis or cirrhosis, viral titer, use of ethanol during therapy,
>patient's race, and
>perhaps the quantity of iron within liver cells. Those individuals with
>genotype 1 HCV will be the least responsive to therapy. Unfortunately, this
>is the most common form of HCV in the United States.
>Identification of those patients most likely to respond to therapy is an
>important consideration in the management of chronic HCV. Symptoms related
>to HCV infection are not predictive of disease activity. Histological liver
>disease may be present without physical signs. Virologic predictors of
>sustained response to therapy include HCV genotype, pretransplant viral
>load, early disappearance of HCV-RNA during treatment, and a negative
>HCV-RNA 6 months after treatment. Stopping interferon therapy based on
>ALT response misses about 33% of sustained responders at week 12 compared
>with 7% using HCV-RNA levels. The sensitivity/specificity of week 4 HCV-RNA
>is higher than that of ALT at weeks 4, 8, and 12. Response appears to be
>affected by genotype (lower rates for genotype 1), race, and previous
>nonresponse to interferon therapy. In addition, alcohol intake, presence of
>cirrhosis, and pretherapy viral load are important factors for predicting
>response, as well as estimating duration, dose, and pattern of
>administration for interferon.
>The titer of HCV can also be a factor in responsiveness. Data has shown
>when viral titer in type 1 HCV is > 2 million copies/mL, only 3% of
>will have a sustained response after 48 weeks of therapy (compared with a
>19% sustained response for those with < 2 million copies/mL.For non-1
>genotypes, the response is 19% and 50%, respectively, based on viral titer.
>HCV viral load by RT-PCR measured in copies/ml with a bearing on follow up
>and treatment outcome is as follows:
>Negative <100 copies
>Low < 1 million copies
>High >2 million copies
>The three interferons that are approved for the treatment of HCV in
>include recombinant interferon alfa-2b (rIFN-alpha2b, INTRON�A,
>Schering-Plough Corporation, Kenilworth, NJ), interferon alfa-2a
>(Roferon-A�, Hoffmann-La Roche Laboratories, Basle, Switzerland) and
>interferon alfacon-1 (INFERGEN�, Amgen Inc., Thousand Oaks, Calif). A
>fourth interferon, interferon alpha-1n (Wellferon�, Glaxo Wellcome Inc.,
>Research Triangle Park, NC), is also approved to treat HCV infection in a
>number of countries. These four interferons appear to be clinically
>Pegylated interferon alpha-2A (PEG) versus standard interferon alpha-2A
>(IFN) for the treatment of hepatitis C has been the subject of recent
>The serum half-life of the pegylated interferon was greater than 90 hours
>as compared to a half life of 4 to 6 hours for IFN. The addition of PEG to
>the standard interferon decreases renal clearance of interferon and reduced
>the need for injection from 3 times/week to 1 time/week whch is its major
>Daily alpha interferon therapy is also emerging as a viable treatment
>option. In a study daily interferon therapy for 1 year was associated with
>normalization of serum ALT in 58% of patients and marked improvement in
>liver inflammatory activity. Furthermore, daily high-dose alpha interferon
>therapy (10 MIU) has been associated with high success rates in terms of
>biochemical and virologic responses .
>(With inputs from AASLD meet)
>Dr Sharat C Misra MD, DM
>Consultant Gastroenterologist & Hepatologist
>Each morning is the doorway to a new world,
>A beginning of infinite possibilities.
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