Effectiveness and safety of the treatment of chronic hepatitis C in patients infected with the human immunodeficiency virus comparing two types of pegylated interferon and ribavirin

INTERVENTION: The objective of this protocol is to obtain data on the effectiveness and safety of the combined treatment with pegylated‐interferon alpha 2b and ribavirin in comparison with the combined treatment with pegylated‐interferon alpha 2a and ribavirin, administered according to standard guidelines, in patients with chronic hepatitis C without prior treatment, co‐infected with HIV and under anti‐retroviral treatment CONDITION: Adult patients diagnosed with chronic compensated hepatitis C, without previous treatment and co‐infected with HIV. ; Infections and Infestations ; Chronic hepatitis C and HIV PRIMARY OUTCOME: To analyse the proportion of patients with sustained virological response maintained (HCV‐RNA not detectable in plasma after 24 weeks to end the therapy) SECONDARY OUTCOME: 1. To analyse the proportion of patients with a virological response (HCV‐RNA not detectable or =2 log10 drop) after 12, 24, 34, 36, and 48 weeks of therapy; 2. To analyse the tolerability and the safety of both treatments in the HIV‐HCV co‐infected patients; 3. To analyse the clinical evolution of these patients; 4. To determine parameters of quality of life in the treated patients; 5. To evaluate the appearance and evolution of lipodystrophy; 6. To evaluate the appearance of mitochondrial toxicity in the patients treated with nucleoside reverse transcriptase inhibitor (NRTI) plus ribavirine; 7. To evaluate the histological response in the respondent patients as well as in the non‐respondent ones INCLUSION CRITERIA: 1. Adult men or women 18‐65 years of age 2. Chronic hepatitis C defined by elevated alanine transaminase (ALT) (1.5 times the upper limit of normal at least on two separate occasions over four weeks, before incorporation in the study 3. Anti‐hepatitis C virus (anti‐HCV) positive according to enzyme‐linked immunosorbent assay (ELISA) and positive ribonucleic acid‐hepatitis C virus (RNA‐HCV) in serum by polymerase chain reaction (PCR) 4. Hepatic biopsy in the 18 months before inclusion in the study showing changes of chronic hepatitis, with or without cirrhosis 5. Compensated hepatopathy, with the following hematological and biochemical criteria: a. Hemoglobin =11 g/dl in females and =12 g/dl in males b. Total leucocytes =3,000 /mm^3 and neutrophyls =1,500 /mm^3 c. Platelets = 80,000 /mm^3 d. Normal prothrombin time and plasmatic albumin e. Normal bilirubin (unless other factors not related to hepatitis, such as Gilbert’s disease, justify it