Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010
TWELVE-WEEK COURSE OF PIFN-α-2A/RIBAVIRIN IS AN OPTIMIZED REGIMEN FOR TREATMENT OF HCV GENOTYPE 2 BUT NOT GENOTYPE 3 NON-CIRRHOTIC PATIENTS WITH RVR
L.E. Adinolfi*, R. Zampino, B. Guerrera, L. Restivo, L. Rinaldi, A. Ciervo, V.R. Scialdone, M. Ferrara, G. Ruggiero
Internal Medicine & Hepatology, Second University of Naples, Naples, Italy. *email@example.com
Background & aim: Patients infected with HCV genotype 2/3 have overall SVR rate of approximately 80% with 24 weeks course peginterferon/ribavirin. A shorter course over 12 weeks seems to be as effective as a 24 weeks for patients who have a RVR (HCV RNA negative at 4 weeks) (N Engl J Med 2005:352:2609). Clinical trial results showed that patients without cirrhosis have a better SVR rate. Thus, current therapy can be optimized in subgroup of CHC patients avoiding overtreatment. We hypothesized that HCV genotype 2 and 3 infected non-cirrhotic patients who attained a RVR have a higher SVR rate with a 12-week course of pIFN/ribavirin.
Methods: Accordingly, the study was designed to have a 80% power with an α error = 0.05 to detect a difference of at least 15% (from 80% to ≥ 95%) in SVR. Based on this assumption, 42 patients for each genotype should be enrolled pending an interim analysis to verify the hypothesis accuracy. The study started in 2006 was concluded in 2009. Forty-two naive patients with HCV genotype 2 and 24 with genotype 3 were enrolled. All patients were non-cirrhotic (at liver biopsy/fibroscan), non-obese (BMI < 30) and were RVR at treatment with pIFN-α-2a (180 mg/week) plus ribavirin (1000-1200 mg/day). Treatment was administered for 12 weeks. HCV RNA was evaluated by real-time PCR (Cobas Amplicor, Roche Diagnostics) at time 0, 4, 12 weeks and at the end of 6 months untreated follow up. HCV genotype was assessed by Inno-Lipa. SVR was defined as a negative HCV RNA at the end of untreated follow up.
Results: The median age was 47 yrs (range:40-56) and 42 yrs (35-48) and, male 54% and 68% for genotype 2 and 3, respectively. Median HCV RNA levels were 480.000 and 420.000 U.I./ml for genotype 2 and 3, respectively. A SVR was achieved in 100% of patients infected with genotype 2. The interim analysis of genotype 3 showed a relapse in 4/24 patients treated invalidating the hypothesis.
Conclusions: A 12-month course of pIFN-α-2a/ribavirin is the optimized therapeutic regimen for treatment of non-cirrhotic/non-obese patients infected with HCV genotype 2 and RVR.