Treatment of chronic hepatitis C in HIV/HCV-coinfection with interferon α-2b+ full-course vs. 16-week delayed ribavirin

✍ Scribed by Norbert Bräu; Maribel Rodriguez-Torres; Dale Prokupek; Maurizio Bonacini; Carol A. Giffen; Jeffery J. Smith; Kevin R. Frost; Jay R. Kostman

• Publisher: John Wiley and Sons
• Year: 2004
• Tongue: English
• Weight: 172 KB
• Volume: 39
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.20107

✦ Synopsis

for the amfAR DCRI 010 Study Group Human immunodeficiency virus (HIV)-infected patients increasingly experience the consequences of chronic hepatitis C virus (HCV) coinfection. This trial randomized 107 patients coinfected with HIV and HCV to receive 48 weeks of interferon alfa-2b (IFN) 3 million units three times weekly plus either a full course of ribavirin (RBV) at 800 mg/day (group A; n ‫؍‬ 53) or 16 weeks of placebo, followed by RBV (group B; n ‫؍‬ 54). The primary endpoint of sustained viral response (SVR) rate (undetectable HCV RNA at posttreatment week 24) was not different between groups A (11.3%) and B (5.6%; P ‫؍‬ .32). Within group A, the SVR rate was lower in genotype 1 (2.5%) than in genotypes 2 through 4 (41.7%; P ‫؍‬ .002). Fifty-five patients discontinued therapy prematurely, mostly because of adverse events or patient decisions. At treatment week 12, the percentage of CD4؉ cells rose in group A (؉4.1%; P < .001), but not in group B (؊0.3%). A significant proportion (22%) of patients who were HIV viremic at baseline had undetectable HIV RNA at week 12. By week 16, the hemoglobin level decreased more in group A (؊2,52 g/dL) than in group B (؊1.02 g/dL; P < .001). In group A, the hemoglobin decline was steeper in patients receiving zidovudine (azidothymidine [AZT], ؊3.64 g/dL vs. no AZT, ؊2.08 g/dL), and patients receiving zidovudine had more anemia-related RBV dose reductions (AZT, 60% vs. no AZT, 16%). In conclusion, HCV therapy with IFN plus RBV is relatively safe in patients coinfected with HIV and HCV, but frequent treatment discontinuations and anemia-related RBV dose reductions contribute to a poor SVR rate. Control of HIV infection improves rather than worsens during therapy. (HEPATOLOGY 2004;39:989 -998.) M ortality resulting from human immunodeficiency virus (HIV) has declined dramatically since the introduction of highly active antiretroviral therapy in 1996. As HIV-infected persons live longer, they increasingly have health problems from comorbidities not related to HIV, chief among them coinfection with the hepatitis C virus (HCV). Persons coinfected with HIV and HCV have a higher mortality rate and a higher rate of hospitalization than patients infected with HIV alone. 1 With declining overall mortality among patients with HIV or acquired immunodeficiency syndrome, relative mortality related to liver disease (especially from HCV infection) is increasing, reaching up to 50% in some centers. 2,3 The prevalence of HCV coinfection in HIV-infected persons depends largely on the method of transmission of HIV itself. It is high with parenteral transmission, such as injection drug use (91%) or transfusion of blood or blood products (71%), but low in sexually transmitted HIV (7.3%). 4 Accordingly, one large HIV clinical trial cohort in the United States (18% injec-