Interferon and ribavirin combination therapy for chronic hepatitis C in human immunodeficiency virus-infected patients with congenital coagulation disorders

We have conducted an open, prospective trial to assess the safety and effic acy of interferon alfa-2b and ribavirin in combination for the treatment of chronic hepatitis C in human immunodeficiency virus (HIV)-infected hemophi liacs. Twenty hemophiliacs coinfected with HIV and hepatitis C virus (HCV), 18 of them under highly active antiretroviral therapy (HAART), with a mean CD4(+) cell count of 490 +/- 176 cells/mm(3) and undetectable (n = 9) or l ow-level HIV RNA (< 10,000 copies/mL; n = 11), were treated with interferon -alfa2b (3 MU thrice weekly) and ribavirin (800 mg/d) for 6 or 12 months ac cording to virologic response. Patients were monitored for tolerance and re sponse at 4, 8, 12, 24, 36, and 48 weeks during treatment and every other m onth thereafter. All 20 patients enrolled completed at least 6 months of tr eatment with no major side effect requiring treatment withdrawal, dose redu ction, or modification of HAART. Overall, 8 patients (40%) achieved a susta ined virologic response at the end of the 6-month post-treatment follow-up. Sustained responders had lower baseline HCV-RNA levels (5.7 +/- 0.8 vs. 6. 3 +/- 0.4 log10 IU/mL, P = .041) but were otherwise similar to nonresponder s. All sustained responders had a decrease in HCV-RNA level of at least 1 l og per month during the first 2 months and undetectable levels at 6 months. In conclusion, our results provide evidence that combination therapy with interferon and ribavirin is safe in HIV-infected hemophiliacs with stable C D4(+) cell count and undetectable or low-level HIV replication, and leads t o eradication of HCV in 40% of these patients.