PMID- 25139963 OWN - NLM STAT- MEDLINE DCOM- 20150901 LR - 20181202 IS - 1537-6591 (Electronic) IS - 1058-4838 (Linking) VI - 59 IP - 12 DP - 2014 Dec 15 TI - Telaprevir for HIV/hepatitis C virus-coinfected patients failing treatment with pegylated interferon/ribavirin (ANRS HC26 TelapreVIH): an open-label, single-arm, phase 2 trial. PG - 1768-76 LID - 10.1093/cid/ciu659 [doi] AB - BACKGROUND: Retreatment with pegylated interferon (peg-IFN) and ribavirin (RBV) results in poor sustained virological response (SVR) rates in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected patients. There are limited data regarding the use of telaprevir plus peg-IFN/RBV in this population. METHODS: HIV type 1-infected patients who previously failed >/=12 weeks of peg-IFN/RBV for HCV genotype 1 coinfection were enrolled in a single-arm, phase 2 trial. Patients with cirrhosis and previous null response were excluded. Authorized antiretrovirals were tenofovir, emtricitabine, efavirenz, atazanavir, and raltegravir. All patients received peg-IFN alfa-2a (180 microg/week) plus RBV (1000-1200 mg/day) for 4 weeks, followed by telaprevir (750 mg or 1125 mg every 8 hours with efavirenz) plus peg-IFN/RBV for 12 weeks and peg-IFN/RBV for 32-56 weeks according to virological response at week 8. The primary endpoint was the SVR rate at 24 weeks after the end of treatment (SVR24). RESULTS: Sixty-nine patients started treatment; SVR24 was achieved in 55 (80% [95% confidence interval, 68%-88%). SVR24 was not influenced by baseline fibrosis stage, IL28B genotype, antiretroviral regimen, HCV subtype, CD4 cell count, previous response to HCV treatment, HCV RNA level, or HCV RNA decline at week 4. HCV treatment was discontinued for adverse events (AEs) in 20% of patients, including cutaneous (4%), psychiatric (4%), hematological (6%), and other AEs (6%). Peg-IFN or RBV dose reduction was required in 23% and 43% of patients, respectively. Seventy percent of patients required erythropoietin, blood transfusions, or RBV dose reduction for anemia. Two patients died during the study. No HIV breakthrough was observed. CONCLUSIONS: Despite a high discontinuation rate related to toxicity, a substantial proportion of treatment-experienced HIV-coinfected patients achieved SVR24 with a telaprevir-based regimen. Clinical Trials Registration. NCT01332955. CI - (c) The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. FAU - Cotte, Laurent AU - Cotte L FAU - Braun, Josephine AU - Braun J FAU - Lascoux-Combe, Caroline AU - Lascoux-Combe C FAU - Vincent, Corine AU - Vincent C FAU - Valantin, Marc-Antoine AU - Valantin MA FAU - Sogni, Philippe AU - Sogni P FAU - Lacombe, Karine AU - Lacombe K FAU - Neau, Didier AU - Neau D FAU - Aumaitre, Hugues AU - Aumaitre H FAU - Batisse, Dominique AU - Batisse D FAU - de Truchis, Pierre AU - de Truchis P FAU - Gervais, Anne AU - Gervais A FAU - Michelet, Christian AU - Michelet C FAU - Morlat, Philippe AU - Morlat P FAU - Vittecoq, Daniel AU - Vittecoq D FAU - Rosa, Isabelle AU - Rosa I FAU - Bertucci, Inga AU - Bertucci I FAU - Chevaliez, Stephane AU - Chevaliez S FAU - Aboulker, Jean-Pierre AU - Aboulker JP FAU - Molina, Jean-Michel AU - Molina JM CN - French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Group LA - eng SI - ClinicalTrials.gov/NCT01332955 PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20140818 PL - United States TA - Clin Infect Dis JT - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JID - 9203213 RN - 0 (Antiviral Agents) RN - 0 (Interferon-alpha) RN - 0 (Oligopeptides) RN - 0 (Recombinant Proteins) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 49717AWG6K (Ribavirin) RN - 655M5O3W0U (telaprevir) RN - Q46947FE7K (peginterferon alfa-2a) SB - IM CIN - Clin Infect Dis. 2014 Dec 15;59(12):1777-8. PMID: 25139964 MH - Antiviral Agents/*therapeutic use MH - Coinfection/*drug therapy MH - Female MH - HIV Infections/*drug therapy MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Interferon-alpha/*therapeutic use MH - Male MH - Middle Aged MH - Oligopeptides/*therapeutic use MH - Polyethylene Glycols/*therapeutic use MH - Recombinant Proteins/therapeutic use MH - Ribavirin/*therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - HCV retreatment OT - HIV/HCV coinfection OT - direct acting agent OT - telaprevir FIR - Aumaitre, Hugues IR - Aumaitre H FIR - Batisse, Dominique IR - Batisse D FIR - Bernard, Louis IR - Bernard L FIR - Cheret, Antoine IR - Cheret A FIR - Cotte, Laurent IR - Cotte L FIR - de Truchis, Pierre IR - de Truchis P FIR - Dellamonica, Pierre IR - Dellamonica P FIR - Dominguez, Stephanie IR - Dominguez S FIR - Gervais, Anne IR - Gervais A FIR - Girard, Pierre-Marie IR - Girard PM FIR - Lucht, Frederic IR - Lucht F FIR - Metivier, Sophie IR - Metivier S FIR - Michelet, Christian IR - Michelet C FIR - Molina, Jean-Michel IR - Molina JM FIR - Morlat, Philippe IR - Morlat P FIR - Neau, Didier IR - Neau D FIR - Pageaux, Georges Philippe IR - Pageaux GP FIR - Pol, Stanislas IR - Pol S FIR - Rosa, Isabelle IR - Rosa I FIR - Rosenthal, Eric IR - Rosenthal E FIR - Vittecoq, Daniel IR - Vittecoq D FIR - Kremlin-Bicetre, Le IR - Kremlin-Bicetre L FIR - Valantin, Marc-Antoine IR - Valantin MA FIR - Zucman, David IR - Zucman D EDAT- 2014/08/21 06:00 MHDA- 2015/09/02 06:00 CRDT- 2014/08/21 06:00 PHST- 2014/08/21 06:00 [entrez] PHST- 2014/08/21 06:00 [pubmed] PHST- 2015/09/02 06:00 [medline] AID - ciu659 [pii] AID - 10.1093/cid/ciu659 [doi] PST - ppublish SO - Clin Infect Dis. 2014 Dec 15;59(12):1768-76. doi: 10.1093/cid/ciu659. Epub 2014 Aug 18.