TY - JOUR
T1 - Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected with Hepatitis C Virus and Human Immunodeficiency Virus Type 1
T2 - The EXPEDITION-2 Study
AU - Rockstroh, Jürgen K.
AU - Lacombe, Karine
AU - Viani, Rolando M.
AU - Orkin, Chloe
AU - Wyles, David
AU - Luetkemeyer, Anne F.
AU - Soto-Malave, Ruth
AU - Flisiak, Robert
AU - Bhagani, Sanjay
AU - Sherman, Kenneth E.
AU - Shimonova, Tatiana
AU - Ruane, Peter
AU - Sasadeusz, Joseph
AU - Slim, Jihad
AU - Zhang, Zhenzhen
AU - Samanta, Suvajit
AU - Ng, Teresa I.
AU - Gulati, Abhishek
AU - Kosloski, Matthew P.
AU - Shulman, Nancy S.
AU - Trinh, Roger
AU - Sulkowski, Mark
N1 - Funding Information:
Acknowledgments. The authors would like to thank the patients and their families who participated in this study and the study investigators and their staff. AbbVie would like to thank Karmin Robinson-Morgan of AbbVie for her contributions to the study. Medical writing support was provided by Zoë Hunter, PhD, of AbbVie. Financial support. This study was supported by AbbVie, Inc.
Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America.
PY - 2018/9/14
Y1 - 2018/9/14
N2 - Background Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1-6 infection. This phase 3 study evaluated the efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV genotype 1-6 and human immunodeficiency virus type 1 (HIV-1) coinfection, including patients with compensated cirrhosis. Methods EXPEDITION-2 was a phase 3, multicenter, open-label study evaluating glecaprevir/pibrentasvir (300 mg/120 mg) in HCV genotype 1-6/HIV-1-coinfected adults without and with compensated cirrhosis for 8 and 12 weeks, respectively. Patients were either HCV treatment-naive or experienced with sofosbuvir, ribavirin, or interferon, and antiretroviral therapy (ART) naive or on a stable ART regimen. Treatment-experienced genotype 3-infected patients were excluded. The primary endpoint was the SVR12 rate. Results In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. The SVR12 rate was 98% (n = 150/153; 95% confidence interval, 95.8-100), with no virologic failures in 137 patients treated for 8 weeks. One genotype 3-infected patient with cirrhosis had on-treatment virologic failure. Most adverse events were mild in severity; 4 patients (2.6%) had serious adverse events, all deemed unrelated to glecaprevir/pibrentasvir. Treatment discontinuation was rare (<1%). All patients treated with ART maintained HIV-1 suppression (<200 copies/mL) during treatment. Conclusions Glecaprevir/pibrentasvir for 8 weeks in noncirrhotic and 12 weeks in cirrhotic patients is a highly efficacious and well-tolerated treatment for HCV/HIV-1 coinfection, regardless of baseline HCV load or prior treatment with interferon or sofosbuvir. Clinical trial registration NCT02738138.
AB - Background Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1-6 infection. This phase 3 study evaluated the efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV genotype 1-6 and human immunodeficiency virus type 1 (HIV-1) coinfection, including patients with compensated cirrhosis. Methods EXPEDITION-2 was a phase 3, multicenter, open-label study evaluating glecaprevir/pibrentasvir (300 mg/120 mg) in HCV genotype 1-6/HIV-1-coinfected adults without and with compensated cirrhosis for 8 and 12 weeks, respectively. Patients were either HCV treatment-naive or experienced with sofosbuvir, ribavirin, or interferon, and antiretroviral therapy (ART) naive or on a stable ART regimen. Treatment-experienced genotype 3-infected patients were excluded. The primary endpoint was the SVR12 rate. Results In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. The SVR12 rate was 98% (n = 150/153; 95% confidence interval, 95.8-100), with no virologic failures in 137 patients treated for 8 weeks. One genotype 3-infected patient with cirrhosis had on-treatment virologic failure. Most adverse events were mild in severity; 4 patients (2.6%) had serious adverse events, all deemed unrelated to glecaprevir/pibrentasvir. Treatment discontinuation was rare (<1%). All patients treated with ART maintained HIV-1 suppression (<200 copies/mL) during treatment. Conclusions Glecaprevir/pibrentasvir for 8 weeks in noncirrhotic and 12 weeks in cirrhotic patients is a highly efficacious and well-tolerated treatment for HCV/HIV-1 coinfection, regardless of baseline HCV load or prior treatment with interferon or sofosbuvir. Clinical trial registration NCT02738138.
KW - EXPEDITION-2
KW - HIV coinfection
KW - cirrhosis
KW - direct-acting antiviral
KW - hepatitis C
UR - http://www.scopus.com/inward/record.url?scp=85049582109&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049582109&partnerID=8YFLogxK
U2 - 10.1093/cid/ciy220
DO - 10.1093/cid/ciy220
M3 - Article
C2 - 29566246
AN - SCOPUS:85049582109
SN - 1058-4838
VL - 67
SP - 1010
EP - 1017
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 7
ER -