Treatment with interferon-alpha2a alone or interferon-alpha2a plus ribavirin in patients with chronic hepatitis C previously treated with interferon-alpha2a

Background: Preliminary results from combination therapy with interferon-al pha and ribavirin (IFN/Rib) in patients with chronic hepatitis C have been promising, with up to 50% sustained hepatitis C virus (HCV) RNA response. T he aim of this study was to investigate whether a sustained HCV RNA respons e could be obtained with combination therapy in patients who were non-repon ders or relapsers after IFN treatment. Methods: In a multicenter study we r andomized 53 HCV RNA-positive patients into 2 treatment groups. They all ha d biopsy-confirmed chronic hepatitis C, and all were recruited from a previ ous IFN study: 26 were previous non-responders and 27 responders with relap se. Group A received interferon-alpha2a. 4.5 MIU thrice weekly for 6 months , and group B received ribavirin, 1000-1200 mg/day, in combination with the same dose of interferon-alpha2a for 6 months. Median Knodell index was 5.0 in both groups. Genotype 1 was found in 24 (45%), type 2 in 3 (6%), and ty pe 3 in 26 (49%). Results: Sustained clearance of HCV viremia 6 months afte r interferon-alpha2a treatment stop was obtained in 12 of 53 patients (23%) : 6 of 27 in the IFN group (22%) and 6 of 26 (23%) in the IFN/Rib group (NS ). Nine of 27 (33%) former responders with relapse, compared with 3 of 26 ( 12%) non-responders, obtained a sustained HCV RNA response (P = 0.054). In previous relapse patients sustained loss of viremia was more frequent in ge notype 3 (50%) than in genotype 1 (11%) patients (P = 0.022). Conclusions: In a group of previous IFN-alpha2a-treated chronic HCV patients we obtained a similar sustained clearance of viremia when retreated either with IFN-al pha2a alone or with a combination of IFN-alpha2a and ribavirin for 6 months . Previous relapse patients with HCV genotype 3 obtained sustained loss of viremia significantly more often (50%) than type-1 patients (11%). Previous IFN responders with relapse responded better than previous non-responders.