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.
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
VL - 67
SP - 1010
EP - 1017
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 7
ER -