Results of a study of prolonging treatment with pegylated interferon-α2a plus ribavirin in HIV/HCV-coinfected patients with no early virological response

Daniel Fuster, Ramon Planas, Juan Gonzalez, Lluís Force, Manel Cervantes, Josep Vilaró, Mercè Roget, Isabel García, Enric Pedrol, Jordi Tor, Angel L. Ballesteros, Anna Salas, Guillem Sirera, Sebastià Videla, Bonaventura Clotet, Cristina Tural

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23 Citations (Scopus)

Abstract

Objective: To assess the efficacy and safety of an extended treatment period in HIV/hepatitis C virus (HCV)-coinfected patients without early virological response (EVR). Methods: Patients received pegylated interferon (peg-INF)-α2a 180 μg/week plus ribavirin 800 mg/d for 12 weeks. Patients achieving EVR at week 12 continued under therapy for an additional 12 or 36 weeks depending on genotype. Patients without EVR were randomized to complete the standard treatment or treatment lasting 72 weeks (extension arm). Results: One hundred and ten patients were included (mean age 38.7 years, mean weight 68 kg, 74% males, 74% on highly active antiretroviral therapy, mean CD4+ T-cell count 564 cells/mm3). Fifty-one patients harboured genotype 1, 44 genotype 2/3, and 15 genotype 4. Fifty-three had an HCV load >800,000 IU/ml. Premature interruptions occurred in 32.7%. EVR was achieved in 63.6% (51% in genotype 1, 88.6% in genotype 2/3, 33.3% in genotype 4). End-of-treatment response was 52.7% (47.2% in genotype 1, 68.20/0 in genotype 2/3, 26.7% in genotype 4). Sustained virological response (SVR) was achieved in 41.8% (37.3% in genotype 1, 54.6% in genotype 2/3, 20% in genotype 4). Only one patient allocated to the extended arm achieved SVR. The rate of drop-outs in the extension arm was 68%. The negative predictive value of EVR was 97.5%. Conclusions: This study shows no benefit of extending therapy in patients without EVR at week 12. Measures to improve adherence to HCV antiviral therapy should be considered when new approaches based on extended periods of treatment are investigated. © 2006 International Medical Press.
Original languageEnglish
Pages (from-to)473-482
JournalAntiviral Therapy
Volume11
Issue number4
Publication statusPublished - 14 Jul 2006

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