861 
Efficacy of Pegylated Interferon + Ribavirin in HIV/HCV Co-infection uutside of Well-circumscribed Clinical Trials: The Andalusian Multicenter Study
J Mira1, J Torre-Cisneros2, D Merino3, M Ríos4, A Collado5, S Vergara1, A Rivero2, J Lomas-Cabeza3, Juan Macías*1, J Pineda1, and the Grupo Andaluz para el Estudio de las Enfermedades Infecciosas
1Hosp de Valme, Sevilla, Spain; 2Hosp Univ Reina Sofía, Córdoba, Spain; 3Hosp Juan Ramón Jiménez, Huelva, Spain; 4Hosp Univ Virgen Macarena, Seville, Spain; and 5Hosp Torrecárdenas, Almería, Spain
Background: Recently, 4 randomized controlled trials have
been published comparing the efficacy of pegylated interferon (PEG-IFN) and ribavirin
(RBV) with that of standard interferon (IFN) and RBV for the treatment of
chronic hepatitis C virus (HCV) in HIV-co-infected patients. In these trials,
the new regimen was superior to the combination of standard IFN/RBV. Thus, the overall
sustained virological response rate with the PEG-IFN/RBV combination ranged
from 27 to 44% in these trials. To date, however, there is little information
about the efficacy of the PEG-IFN/RBV combination, used in real conditions, in
subjects with HIV and HCV infections. Our
objective was to assess the efficacy of PEG-INF + RBV in a clinical cohort of HIV-infected
patients with chronic hepatitis C.
Methods: All
HIV/HCV-co-infected patients who received at least 1 dose of the PEG-IFN/RBV combination
between June 2000 and February 2005 in southern Spain, were included in the study. Patients were treated with
PEG-IFN-a-2a (180µg weekly) or PEG-IFNa-2b (1.5 µg/kg weekly) and RBV (800 to 1200
mg/day) for 24 or 48 weeks. Patients discontinued the therapy at week 12 in the
absence of an early virological response. The primary endpoint was the rate of sustained
virological response, defined as undetectable HCV RNA
in serum at 24 weeks after cessation the therapy. Secondary endpoints were
rates of early virological response and viral
response at the end of treatment, and percentage of premature discontinuation
of the therapy. Viral response was measured on an intention-to-treat-basis.
Results: We
included 145 patients in this study. Viral response at the end of treatment and
sustained virological response were observed in 64
(44%) and 47 (32%) individuals, respectively. Among the 86 subjects with
genotype 1 or 4, 16 (19%) achieved sustained virological
response, whereas 31 (53%) of 59 individuals carrying genotypes 2 or 3 did so. Of
the subjects with genotypes 1 or 4, and with genotypes 2 or 3, 29 (34%) and 3
(5%) did not reach early virological response,
respectively. After end of treatment, 17 (12%) patients relapsed, 24 (16%) individuals
discontinued therapy due to adverse events, and 13 (9%) were lost to follow-up
or refused to continue the therapy.
Conclusions: The
efficacy of the PEG-IFN/RBV in HIV/HCV-co-infected patients outside of
well-circumscribed trials is much lower than in most clinical trials. This is
attributable to a high rate of nonresponders among those with HCV genotype 1 or
4 infection.
|
