In clinical trials, PEGASYSalone or in combination with COPEGUS® (Ribavirin, USP)provided predictable and reproducible sustained virologic response (SVR) rates regardless of patient type.
Sustained Virologic Response (SVR) Rates in PEGASYS + COPEGUS Trials
PEGASYS + COPEGUS combination therapy was evaluated in patients with hepatitis C monoinfection in two separate clinical trials:
- In a study conducted by Fried et al, patients were randomized to receive either PEGASYS 180 µg qw with placebo, PEGASYS 180 µg qw with COPEGUS 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg), or Rebetron® (interferon alfa-2b 3 MIU tiw plus 1000 mg or 1200 mg ribavirin) for 48 weeks of therapy followed by 24 weeks of treatment-free follow-up.1,2
- In a double-blind clinical trial, all patients received PEGASYS 180 µg qw and were randomized to treatment for either 24 or 48 weeks and to a COPEGUS dose of either 800 mg or 1000 mg/1200 mg (for body weight <75 kg/≥75 kg).3
- In both trials, SVR was defined as undetectable HCV RNA value at the end of the 24-week treatment-free follow-up period (week 72).1-3
SVR Regardless of Patient Type
In two clinical trials, more than half of all patients on PEGASYS + COPEGUS combination therapy achieved an SVR. Response rates for patients with genotype 1 were 44% and 51% in the 2 studies.1-3
Patients With High Viral Load (>800,000 IU/mL)
In two clinical studies, 53% and 59% of all patients on PEGASYS + COPEGUS combination therapy achieved an SVR. Patients with genotype 1 had an SVR rate of 41% and 47%, respectively, in the same studies.1,3
Patients With Cirrhosis
Patients with cirrhosis at the start of combination therapy with PEGASYS + COPEGUS responded at an overall rate (for all genotypes) of 49%. Patients with genotype 1 had a 37% SVR rate.4
Coinfected Patients
Among all patients with both HCV and HIV on PEGASYS + COPEGUS combination therapy, 40% (116 of 289) achieved an SVR. The rate was 29% (51 of 176) among coinfected patients with HCV genotype 1.5
Patients With HBV Monoinfection
Patients with HBeAg-positive HBV on PEGASYS monotherapy demonstrated seroconversion in 32% of cases (87 of 271).6 Among patients with HBeAg-negative HBV, 43% (76 of 177) showed an HBV DNA response and 59% (105 of 177) had evidence of ALT normalization.7
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