Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected with Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study

Jürgen K. Rockstroh, Karine Lacombe, Rolando M. Viani, Chloe Orkin, David Wyles, Anne F. Luetkemeyer, Ruth Soto-Malave, Robert Flisiak, Sanjay Bhagani, Kenneth E. Sherman, Tatiana Shimonova, Peter Ruane, Joseph Sasadeusz, Jihad Slim, Zhenzhen Zhang, Suvajit Samanta, Teresa I. Ng, Abhishek Gulati, Matthew P. Kosloski, Nancy S. ShulmanRoger Trinh, Mark Sulkowski

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)1010-1017
Number of pages8
JournalClinical Infectious Diseases
Volume67
Issue number7
DOIs
StatePublished - Sep 14 2018

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Keywords

  • EXPEDITION-2
  • HIV coinfection
  • cirrhosis
  • direct-acting antiviral
  • hepatitis C

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Rockstroh, J. K., Lacombe, K., Viani, R. M., Orkin, C., Wyles, D., Luetkemeyer, A. F., Soto-Malave, R., Flisiak, R., Bhagani, S., Sherman, K. E., Shimonova, T., Ruane, P., Sasadeusz, J., Slim, J., Zhang, Z., Samanta, S., Ng, T. I., Gulati, A., Kosloski, M. P., ... Sulkowski, M. (2018). Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected with Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study. Clinical Infectious Diseases, 67(7), 1010-1017. https://doi.org/10.1093/cid/ciy220