BACKGROUND: Current therapies for chronic hepatitis C virus (HCV) in HIV co-infected patients have a low success rate and are poorly tolerated. We have evaluated the efficacy and safety of interferon alfa-2b (IFN) + ribavirin (RBV) versus pegylatedinterferon alfa-2b (PEG-INF) + RBV. METHODS: Randomized, single-centre, open-label clinical trial including patients with: detectable HCV-RNA, alanine aminotransferase > 1.5-fold upper limit of normal, abnormal liver histology, CD4 cell count > 250 x 10/l and HIV RNA < 10 000 copies/ml. Patients were assigned to INF (3 x 10 units three times/week) or PEG-IFN (100-150 microg/week) plus RBV (800-1200 mg/day). Duration of treatment was 48 weeks (only 24 weeks for HCV genotypes 2 or 3 and baseline HCV RNA < 800 000 IU/ml). The primary endpoint was a sustained virological response (SVR). RESULTS: Ninety-five patients were randomized (43 INF + RBV, 52 PEG-INF + RBV), 68% males, 82% injecting drug users; 63% genotypes 1 or 4 and 36% genotypes 2 or 3; 62% fibrosis index grade >/=2 and 30% bridging fibrosis/cirrhosis. SVR was significantly higher in the PEG-INF + RBV arm, 44% versus 21% (intent to treat; P = 0.017). Among patients with genotypes 1 or 4, SVR were 38% versus 7% (P = 0.007) and 53% versus 47% (P = 0.730) for genotypes 2 or 3. CD4 cell count but not its percentage dropped in both arms and HIV RNA viral load did not change from baseline. Side effects were very frequent in both arms leading to treatment discontinuation in 14 patients without statistical differences between arms (P = 0.565). CONCLUSION:PEG-INF + RBV was significantly more effective than INF + RBV for the treatment of chronic hepatitis C in HIV co-infected patients, mainly of genotype 1 or 4.
RCT Entities:
BACKGROUND: Current therapies for chronic hepatitis C virus (HCV) in HIV co-infectedpatients have a low success rate and are poorly tolerated. We have evaluated the efficacy and safety of interferon alfa-2b (IFN) + ribavirin (RBV) versus pegylated interferon alfa-2b (PEG-INF) + RBV. METHODS: Randomized, single-centre, open-label clinical trial including patients with: detectable HCV-RNA, alanine aminotransferase > 1.5-fold upper limit of normal, abnormal liver histology, CD4 cell count > 250 x 10/l and HIV RNA < 10 000 copies/ml. Patients were assigned to INF (3 x 10 units three times/week) or PEG-IFN (100-150 microg/week) plus RBV (800-1200 mg/day). Duration of treatment was 48 weeks (only 24 weeks for HCV genotypes 2 or 3 and baseline HCV RNA < 800 000 IU/ml). The primary endpoint was a sustained virological response (SVR). RESULTS: Ninety-five patients were randomized (43 INF + RBV, 52 PEG-INF + RBV), 68% males, 82% injecting drug users; 63% genotypes 1 or 4 and 36% genotypes 2 or 3; 62% fibrosis index grade >/=2 and 30% bridging fibrosis/cirrhosis. SVR was significantly higher in the PEG-INF + RBV arm, 44% versus 21% (intent to treat; P = 0.017). Among patients with genotypes 1 or 4, SVR were 38% versus 7% (P = 0.007) and 53% versus 47% (P = 0.730) for genotypes 2 or 3. CD4 cell count but not its percentage dropped in both arms and HIV RNA viral load did not change from baseline. Side effects were very frequent in both arms leading to treatment discontinuation in 14 patients without statistical differences between arms (P = 0.565). CONCLUSION: PEG-INF + RBV was significantly more effective than INF + RBV for the treatment of chronic hepatitis C in HIV co-infectedpatients, mainly of genotype 1 or 4.
Authors: Joseph Rasimas; Antonios Katsounas; Haniya Raza; Alison A Murphy; Jun Yang; Richard A Lempicki; Anu Osinusi; Henry Masur; Michael Polis; Shyam Kottilil; Donald Rosenstein Journal: J Acquir Immune Defic Syndr Date: 2012-07-01 Impact factor: 3.731
Authors: V Martel-Laferrière; S Brinkley; K Bichoupan; S Posner; A Stivala; P Perumalswami; Td Schiano; M Sulkowski; Dt Dieterich; Ad Branch Journal: HIV Med Date: 2013-09-11 Impact factor: 3.180
Authors: Marie-Louise C Vachon; Stephanie H Factor; Andrea D Branch; Maria-Isabel Fiel; Maribel Rodriguez-Torres; Norbert Bräu; Richard K Sterling; Jihad Slim; Andrew H Talal; Douglas T Dieterich; Mark S Sulkowski Journal: J Hepatol Date: 2010-08-21 Impact factor: 25.083
Authors: Fazal A Danish; Salman S Koul; Fazal R Subhani; Ahemd E Rabbani; Saeeda Yasmin Journal: Saudi J Gastroenterol Date: 2008-07 Impact factor: 2.485
Authors: Fernando H Wolff; Sandra C Fuchs; Nêmora N T Barcellos; Paulo Ricardo de Alencastro; Maria Letícia R Ikeda; Ajácio B M Brandão; Maicon Falavigna; Flávio D Fuchs Journal: PLoS One Date: 2010-05-05 Impact factor: 3.240