Oct 08, 2008
I just learned that I'm undie at week 4 and since I'm at 1B and I started with a very low VL, I might qualify for a shorter duration??? I'll have to ask my doc about this:
March 6th, 2007
PEGASYS(R) Gets European Approval for a Shorter Treatment Duration for Some Genotype 1 and 4 Hepatitis C Patients who Show a Rapid Response to Therapy
- Shorter, Simplified Treatment Option May Encourage More Patients to Seek Treatment
Some hepatitis C patients with difficult-to-treat HCV genotype 1 who respond quickly to treatment with a combination of PEGASYS(R) (pegylated interferon alfa-2a (40KD)) plus COPEGUS(R) (ribavirin) can benefit from a shorter and simplified course of therapy, following Thursday's Commission decision. With the new approval, a subset of patients with genotypes 1 and 4 HCV who achieve rapid viral response can now receive a shortened, 24-week duration of treatment with Roche's PEGASYS plus COPEGUS. This is half the normal treatment duration.
Shorter, Simplified Treatment Shows Excellent Chance for a Cure
The EU approval is based on data from two pivotal clinical trials for PEGASYS plus COPEGUS.(1,2) Results from these trials show that among patients who achieved a rapid viral response (undetectable viral load at week 4) in the first month of treatment up to 93 per cent of patients with genotype 1 HCV with a low pre-treatment viral load and 83 per cent of patients with genotype 4 were cured following only 24 weeks of therapy - a similar cure rate to that seen following 48 weeks of therapy.(3)
"This is excellent news for patients with hepatitis C," said Dr Peter Ferenci, Professor of the Department of Internal Medicine IV, Gastroenterology and Hepatology, at the University of Vienna, Austria. "This means that patients can find out within one month of starting therapy if they have an excellent chance of being cured and can benefit from a shortened treatment duration. This is likely to encourage patients to seek treatment and motivate them to stay on therapy."
New Recommendations for Treatment
A shorter, 24-week course with PEGASYS plus COPEGUS is now an option for the following patients:(4)
Genotype 1 HCV with a low pre-treatment viral load (defined as <800,000 IU/mL) and an undetectable viral load at weeks 4 and 24;
Genotype 4 HCV regardless of pre-treatment viral load and an undetectable viral load at weeks 4 and 24.
"This licence change reflects Roche's commitment to finding better treatment solutions for patients with HCV by improving treatment with existing therapies and developing new medicines to treat hepatitis C," said Claire Steers, PEGASYS Lifecycle Leader at Roche in Basel, Switzerland. "Roche is committed to finding solutions for a broad range of hepatitis C patients by continuing to simplify treatment with PEGASYS."
24 Weeks of Pegylated Interferon plus Ribavirin May Be Sufficient for Selected Genotype 1/4 Chronic Hepatitis C Patients with Rapid Response
By Liz Highleyman
Given the side effects and cost of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers continue to explore shorter treatment durations, especially for individuals who respond rapidly after starting therapy.
The current standard of care is 24 weeks of pegylated interferon plus ribavirin for chronic hepatitis C patients with HCV genotypes 2 or 3, while those with hard-to-treat genotypes 1 or 4 are treated for 48 weeks. Many experts recommend longer therapy for individuals with HIV-HCV coinfection.
In a study described in the August 2008 issue of Gastroenterology, Peter Ferenci and colleagues from Austria aimed to determine whether 24 weeks might be adequate for patients with HCV genotype 1 or 4 who achieve rapid virological response (RVR), or undetectable after 4 weeks of therapy.
The study initially included 516 genotype 1 or 4 patients treated with 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus 1000-1200 mg/day weight-based ribavirin. Participants who did not achieve RVR (HCV RNA < 50 copies/mL) at week 4 were randomly assigned to receive 48 or 72 weeks of treatment (this part of the study was ongoing at the time of the report).
Among those who did achieve RVR, the investigators analyzed rates of sustained virological response (SVR), or continued undetectable HCV viral load 24 weeks after completion of therapy.
• 150 of the 516 patients (26%) achieved RVR.
• 143 of the 150 completed 24 weeks of treatment.
• The overall SVR rate in this subgroup was 80.4%:
• 78.8% for genotype 1;
• 86.7% for genotype 4.
• The following factors were predictive of RVR:
• younger age;
• lower body fat;
• low baseline HCV RNA (< 400,000 IU/mL);
• HCV genotype 4 rather than 1.
• However, once a person had achieved RVR, no baseline factors significantly predicted SVR.
• Treatment was well tolerated overall.
Based on these findings, the investigators concluded, "This prospective study confirms that a 24-week regimen of peginterferon alfa-2a plus ribavirin 1000-1200 mg/day is appropriate in genotype 1 and 4 patients with a low baseline HCV RNA level who achieve an RVR by week 4 of therapy."
Medical University, Vienna, Austria; Kaiser-Franz-Josef-Spital, Vienna, Austria; Wilhelminenspital, Vienna, Austria; Elisabethinen Hospital, Linz, Austria; Hospital Hietzing, Vienna, Austria; Medical University, Graz, Austria; Rudolfshospital, Vienna, Austria; LKH Hörgas-Enzenbach, Gratwein, Austria; Krankenhaus, Oberndorf, Austria; Roche Austria, Vienna, Austria.
P Ferenci, H Laferl, TM Scherzer, and others. Peginterferon alfa-2a and ribavirin for 24 weeks in hepatitis C type 1 and 4 patients with rapid virological response. Gastroenterology 135(2): 451-458. August 2008. (Abstract).