The study protocol was approved by the Agencia Espa?ola del Medicamento, and a central ethics committee (Comit�� Auton��mico de Ensayos Cl��nicos, Consejer��a de Salud, Junta de Andaluc��a). The study was conducted according to the Declaration of Helsinki and current guidelines on Good Clinical Practices. All patients provided written informed consent. This study is registered at NIH www.selleckchem.com/products/Y-27632.html register (ClinicalTrials.gov: NCT00553930) and EMEA (N�� EudraCT: 2007-000814-35). Design and study population This was a pilot, open-label, single arm, investigator-initiated clinical trial in which Caucasian HCV treatment naive patients were prospectively enrolled in four infectious disease units in Spain from January 2008 to August 2009. The trial ended after the completed follow-up of the last enrolled patient.

Patients were eligible if they were older than 18 years, HIV-coinfected, and had CHC or compensated cirrhosis by HCV G3. Although the initial protocol contemplated the inclusion of patients carrying HCV G2, these were excluded from analysis as only two of these patients were enrolled. Patients were treated under routine clinical care conditions, and liver biopsy was not mandatory for inclusion in the study. Patients were excluded if they had active HIV-related opportunistic infection, cancer, hepatitis B coinfection, other causes of liver disease, hemoglobinopathies, previous history of severe psychiatric illness, autoimmune diseases, abnormal renal function, or pregnancy. There were no exclusion criteria regarding methadone use, CD4 cell counts, plasma HIV-RNA, or concurrent antiretroviral therapy.

Laboratory tests HCV genotypes were determined using a reverse hybridization assay (Inno-Lipa HCV II; Bayer, Barcelona, Spain). Plasma HCV-RNA loads were measured by a quantitative PCR assay (COBAS? AmpliPrep/COBAS? TaqMan? HCV Test; detection limit of 15 IU/ml) at baseline, after weeks 1, 2, 4, and monthly thereafter until the end of treatment, and again at 6 months after completing treatment. Hematological and biochemical profiles were also assessed at the same time points. CD4 counts (standard flow cytometry) and plasma HIV-RNA (Cobas AmpliPrep-Cobas TaqMan HIV-1 test, v.2.0, Basel, Switzerland) were measured at baseline and every three months thereafter. Batimastat Hepatic fibrosis was evaluated by pretreatment liver biopsy according to the Scheuer’s scoring system [20], or by transient elastography (Fibroscan?, Echosens) for which values of ��11 and ��14 kPa were considered as F3 and F4 fibrosis stages, respectively. Genomic DNA was extracted from whole blood provided in EDTA tubes using the QIAmp DNA Blood Kit (Qiagen). The rs129679860 SNP was genotyped with a custom TaqMan genotyping assay (Applied Biosystems) on DNA isolated from whole blood samples.