PMID- 28282271 OWN - NLM STAT- MEDLINE DCOM- 20180112 LR - 20211204 IS - 1557-7465 (Electronic) IS - 1079-9907 (Linking) VI - 37 IP - 3 DP - 2017 Mar TI - Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. PG - 103-111 LID - 10.1089/jir.2016.0082 [doi] AB - To evaluate the efficacy and safety of pegylated interferon-lambda-1a (Lambda)/ribavirin (RBV)/daclatasvir (DCV) for treatment of patients coinfected with chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Treatment-naive patients were assigned to cohort A [HCV genotype (GT)-2 or -3] or cohort B [HCV GT-1(a or b) or -4]. All patients received Lambda/RBV/DCV for the first 12 weeks; cohort A received Lambda/RBV for an additional 12 weeks, followed by 24 weeks of follow-up, and cohort B received response-guided therapy. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post-treatment week 12 (SVR12). In cohort A (n = 104), 84.6% achieved SVR12 (95.0% in GT-2; 83.1% in GT-3). In cohort B (n = 196), 76.0% achieved SVR12 (71.7% in GT-1a; 86.0% in GT-1b; 70.7% in GT-4). Rates of discontinuation due to adverse events (AEs) (3.8% and 6.1%) and serious AEs (5.8% and 6.1%) were low in cohorts A and B, respectively. In addition, treatment with Lambda/RBV/DCV had little impact on CD4 counts. SVR12 rates with Lambda/RBV/DCV in an HCV/HIV-coinfected population ranged from 71.7% to 95.0%. Treatment was generally well tolerated, with a low proportion of patients discontinuing due to AEs. Clinical trial registration NCT01866930. FAU - Nelson, Mark AU - Nelson M AD - 1 Chelsea and Westminster Hospital , London, United Kingdom . FAU - Rubio, Rafael AU - Rubio R AD - 2 Hospital Universitario 12 Octubre , Centro de Actividades Ambulatorias, Madrid, Spain . FAU - Lazzarin, Adriano AU - Lazzarin A AD - 3 Scientific Institute Ospedale , San Raffaele, Milan, Italy . FAU - Romanova, Svetlana AU - Romanova S AD - 4 State Research Center-Institute of Biophysics , Russian Ministry of Health, Moscow, Russia . FAU - Luetkemeyer, Annie AU - Luetkemeyer A AD - 5 Zuckerberg San Francisco General, University of California , San Francisco, San Francisco, California. FAU - Conway, Brian AU - Conway B AD - 6 Vancouver Infectious Diseases Centre , Vancouver, Canada . FAU - Molina, Jean-Michel AU - Molina JM AD - 7 Department of Infectious Diseases, Hopital Saint-Louis, Assistance Publique Hopitaux de Paris, University of Paris Diderot , Paris, France . FAU - Xu, Dong AU - Xu D AD - 8 Bristol-Myers Squibb , Wallingford, Connecticut. FAU - Srinivasan, Subasree AU - Srinivasan S AD - 8 Bristol-Myers Squibb , Wallingford, Connecticut. FAU - Portsmouth, Simon AU - Portsmouth S AD - 9 Shionogi Inc. , Florham Park, New Jersey. LA - eng SI - ClinicalTrials.gov/NCT01866930 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study DEP - 20170217 PL - United States TA - J Interferon Cytokine Res JT - Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research JID - 9507088 RN - 0 (Carbamates) RN - 0 (Imidazoles) RN - 0 (Pyrrolidines) RN - 0 (interferon-lambda, human) RN - 49717AWG6K (Ribavirin) RN - 9008-11-1 (Interferons) RN - HG18B9YRS7 (Valine) RN - LI2427F9CI (daclatasvir) SB - IM MH - Adult MH - Aged MH - CD4 Lymphocyte Count MH - Carbamates MH - *Coinfection MH - Drug Therapy, Combination MH - Female MH - Genotype MH - HIV Infections/immunology/*virology MH - Hepacivirus/*genetics MH - Hepatitis C/*drug therapy/*virology MH - Humans MH - Imidazoles/administration & dosage/adverse effects/*therapeutic use MH - Interferons/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Pyrrolidines MH - Ribavirin/administration & dosage/adverse effects/*therapeutic use MH - Treatment Outcome MH - Valine/analogs & derivatives MH - Viral Load OTO - NOTNLM OT - IFN receptors OT - IFNs and cytokines OT - antiviral actions OT - infectious disease EDAT- 2017/03/11 06:00 MHDA- 2018/01/13 06:00 CRDT- 2017/03/11 06:00 PHST- 2017/03/11 06:00 [entrez] PHST- 2017/03/11 06:00 [pubmed] PHST- 2018/01/13 06:00 [medline] AID - 10.1089/jir.2016.0082 [doi] PST - ppublish SO - J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.