Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1010-1017 |
| Number of pages | 8 |
| Journal | Clinical Infectious Diseases |
| Volume | 67 |
| Issue number | 7 |
| DOIs | |
| State | Published - Sep 14 2018 |
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Keywords
- cirrhosis
- direct-acting antiviral
- EXPEDITION-2
- hepatitis C
- HIV coinfection
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases
Cite this
Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected with Hepatitis C Virus and Human Immunodeficiency Virus Type 1 : The EXPEDITION-2 Study. / Rockstroh, Jürgen K.; Lacombe, Karine; Viani, Rolando M.; Orkin, Chloe; Wyles, David; Luetkemeyer, Anne F.; Soto-Malave, Ruth; Flisiak, Robert; Bhagani, Sanjay; Sherman, Kenneth E.; Shimonova, Tatiana; Ruane, Peter; Sasadeusz, Joseph; Slim, Jihad; Zhang, Zhenzhen; Samanta, Suvajit; Ng, Teresa I.; Gulati, Abhishek; Kosloski, Matthew P.; Shulman, Nancy S.; Trinh, Roger; Sulkowski, Mark.
In: Clinical Infectious Diseases, Vol. 67, No. 7, 14.09.2018, p. 1010-1017.Research output: Contribution to journal › Article
}
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
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 - cirrhosis
KW - direct-acting antiviral
KW - EXPEDITION-2
KW - hepatitis C
KW - HIV coinfection
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
VL - 67
SP - 1010
EP - 1017
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 7
ER -