Common TitleAPRICOT Study
Purpose / DescriptionThe phase 3, randomized, controlled APRICOT study is one of the sentinel trials of peginterferon alfa-2a in patients coinfected with HCV and HIV. Investigators randomized 868 HCV-HIV coinfected patients to one of three treatment arms, each 48 weeks in duration: (1) peginterferon alfa-2a plus ribavirin 800 mg/day, (2) peginterferon alfa-2a plus placebo, and (3) standard interferon alfa-2a plus ribavirin 800 mg/day. Among study participants, 84% were on antiretroviral therapy and 16% had cirrhosis. The combination of peginterferon alfa-2a and ribavirin generated significantly higher sustained virologic response rates compared with peginterferon alfa-2a monotherapy (40% versus 20%, p<0.001) and standard interferon alfa-2a plus ribavirin (40% versus 12%, p<0.001). The difference in SVR rates was most notable in patients with genotype 1 infection (29% versus 14% and 7% respectively, p<0.001). In addition, patients in the standard interferon arm had higher treatment discontinuation rates than patients in the peginterferon alfa-2a arms. This study clearly established that (1) peginteferon alfa-2a and ribavirin was superior to standard interferon alfa-2a and ribavirin in persons coinfected with HIV, and (2) the addition of ribavirin to peginterferon alfa-2a significantly improves SVR rates in persons coinfected with HIV.