TY - JOUR
T1 - Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION)
T2 - A non-randomised, open-label trial
AU - Rockstroh, Jürgen K.
AU - Nelson, Mark
AU - Katlama, Christine
AU - Lalezari, Jay
AU - Mallolas, Josep
AU - Bloch, Mark
AU - Matthews, Gail V.
AU - Saag, Michael S.
AU - Zamor, Philippe J.
AU - Orkin, Chloe
AU - Gress, Jacqueline
AU - Klopfer, Stephanie
AU - Shaughnessy, Melissa
AU - Wahl, Janice
AU - Nguyen, Bach Yen T.
AU - Barr, Eliav
AU - Platt, Heather L.
AU - Robertson, Michael N.
AU - Sulkowski, Mark
N1 - Funding Information:
The authors thank Anita Howe and Mary Motyl for sequencing analysis data, and David Nickle and Kavita Bekkarri for phylogenetic data. Medical writing and editorial assistance was provided by Tim Ibbotson PhD and Beth McMahon-Wise PhD of ApotheCom. This assistance was funded by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc (Kenilworth, NJ, USA).
Funding Information:
JKR has received grant support from Gilead; has served as a consultant/adviser for AbbVie, Bionor, Bristol-Myers Squibb, Gilead, Janssen, Merck, and ViiV; and as a speaker for AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and ViiV. MN has received grant support from MSD, Bristol-Myers Squibb, ViiV, Boehringer Ingelheim, AbbVie, Gilead, and Janssen. CK has received grant support from Bristol-Myers Squibb, and Janssen; and has served as consultant for MSD, Bristol-Myers Squibb, and Gilead. JL has received research support from Merck. JM has received grant support from Merck, Bristol-Myers Squibb, Gilead, ViiV, and AbbVie; has served on advisory boards for Merck, Bristol-Myers Squibb, Gilead, ViiV, and Roche; and received support for conference travel from Gilead, Bristol-Myers Squibb, Merck, ViiV, and AbbVie. MB has received grant support from Merck, Bristol-Myers Squibb, Gilead, ViiV, and AbbVie; has served on advisory boards for Merck, Bristol-Myers Squibb, Gilead, and ViiV; and received support for conference travel from Gilead, Bristol-Myers Squibb, Merck, ViiV, and AbbVie. GVM has received grant support from Gilead, MSD, AbbVie, and Janssen; has served as a consultant for AbbVie, Gilead, and MSD; and has received travel support from Bristol-Myers Squibb, Gilead, and Roche. MSS has received grant support from Merck, Bristol-Myers Squibb, Gilead, ViiV, Janssen, and AbbVie. PJZ has received grant support from Bristol-Myers Squibb, Gilead, AbbVie, and Merck; has served as a consultant/adviser for Janssen, and as a speaker for Janssen and AbbVie. CO has received grant support from Merck, Bristol-Myers Squibb, Gilead, ViiV, and AbbVie; has served on advisory boards for MSD, Gilead, and ViiV; and has received support for conference travel from Gilead, Bristol-Myers Squibb, Merck, ViiV, and AbbVie. JG, SK, MSh, JW, B-YTN, EB, HLP, and MNR are employees/shareholders of Merck. MSu has received research grant to Johns Hopkins University from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck; has served as a consultant/adviser for Achillion, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck; and served as a member of a data and safety monitoring board to Johns Hopkins University for Gilead.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - Background Hepatitis C virus (HCV) infection is a leading cause of morbidity and mortality in patients with HIV-1. The C-EDGE CO-INFECTION study assessed the effi cacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection. Methods In this uncontrolled, non-randomised, phase 3, open-label, single-arm study, treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection and HIV co-infection, with or without cirrhosis, were enrolled from 37 centres in nine countries across Europe, the USA, and Australia. Patients were either naive to treatment with any antiretroviral therapy (ART) or stable on ART for at least 8 weeks. All patients received grazoprevir 100 mg plus elbasvir 50 mg in a fi xed-dose combination tablet once daily for 12 weeks. The primary endpoint was sustained virological response (HCV RNA <15 IU/mL) 12 weeks after the end of therapy (SVR12). The primary population for effi cacy analyses was all patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, number NCT02105662. Findings Between June 11, 2014, and Aug 29, 2014, 218 patients were enrolled and received grazoprevir plus elbasvir for 12 weeks, all of whom completed follow-up at week 12. SVR12 was achieved by 210 (96%) of 218 patients (95% CI 92.9-98.4). One patient did not achieve SVR12 because of a non-virological reason, and seven patients without cirrhosis relapsed (two subsequently confi rmed as reinfections). All 35 patients with cirrhosis achieved SVR12. The most common adverse events were fatigue (29; 13%), headache (27; 12%), and nausea (20; 9%). No patient discontinued treatment because of an adverse event. Two patients receiving ART had transient HIV viraemia. Interpretation This HCV treatment regimen seems to be eff ective and well tolerated for patients co-infected with HIV with or without cirrhosis. These data are consistent with previous trials of this regimen in the monoinfected population. This regimen continues to be studied in phase 3 trials.
AB - Background Hepatitis C virus (HCV) infection is a leading cause of morbidity and mortality in patients with HIV-1. The C-EDGE CO-INFECTION study assessed the effi cacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection. Methods In this uncontrolled, non-randomised, phase 3, open-label, single-arm study, treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection and HIV co-infection, with or without cirrhosis, were enrolled from 37 centres in nine countries across Europe, the USA, and Australia. Patients were either naive to treatment with any antiretroviral therapy (ART) or stable on ART for at least 8 weeks. All patients received grazoprevir 100 mg plus elbasvir 50 mg in a fi xed-dose combination tablet once daily for 12 weeks. The primary endpoint was sustained virological response (HCV RNA <15 IU/mL) 12 weeks after the end of therapy (SVR12). The primary population for effi cacy analyses was all patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, number NCT02105662. Findings Between June 11, 2014, and Aug 29, 2014, 218 patients were enrolled and received grazoprevir plus elbasvir for 12 weeks, all of whom completed follow-up at week 12. SVR12 was achieved by 210 (96%) of 218 patients (95% CI 92.9-98.4). One patient did not achieve SVR12 because of a non-virological reason, and seven patients without cirrhosis relapsed (two subsequently confi rmed as reinfections). All 35 patients with cirrhosis achieved SVR12. The most common adverse events were fatigue (29; 13%), headache (27; 12%), and nausea (20; 9%). No patient discontinued treatment because of an adverse event. Two patients receiving ART had transient HIV viraemia. Interpretation This HCV treatment regimen seems to be eff ective and well tolerated for patients co-infected with HIV with or without cirrhosis. These data are consistent with previous trials of this regimen in the monoinfected population. This regimen continues to be studied in phase 3 trials.
UR - http://www.scopus.com/inward/record.url?scp=84946216260&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84946216260&partnerID=8YFLogxK
U2 - 10.1016/S2352-3018(15)00114-9
DO - 10.1016/S2352-3018(15)00114-9
M3 - Article
C2 - 26423374
AN - SCOPUS:84946216260
VL - 2
SP - e319-e327
JO - The Lancet HIV
JF - The Lancet HIV
SN - 2352-3018
IS - 8
ER -