Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial

Abstract

This study assessed the efficacy and safety of ribavirin‐free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR‐II, Part 3 was a partially randomized, open‐label, multicenter, phase 3 study. Treatment‐experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment‐naive or treatment‐experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment‐experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72‐97) and 95% (21/22; 95% CI, 78‐99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87‐99) of treatment‐naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86‐99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated. (Hepatology 2018;67:514‐523).

Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial

“…In the SURVEYOR II study, 3 of 4 (75%) treatment‐experienced participants with cirrhosis and HCV GT3 infection receiving glecaprevir/pibrentasvir for 16 weeks achieved SVR . In part 3 of this study, 96% (45/47) of treatment‐experienced participants with cirrhosis and HCV GT3 infection achieved SVR12 after 16 weeks . Therefore, the 16‐week regimen of this combination was recently approved for treatment‐experienced people with HCV GT3 infection and compensated cirrhosis.…”

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…Although the registration trial included only adolescents with genotype 1‐4, glecaprevir/pibrentasvir garnered FDA approval for all genotypes based on the safety and efficacy of the regimen demonstrated in adults . The recommendations for use of glecaprevir/pibrentasvir in treatment‐experienced adolescents are also based on clinical trial data from adults . Given its pangenotypic activity and safety and efficacy records in adults, the HCV guidance panel recommends glecaprevir/pibrentasvir as the first choice for adolescent HCV treatment.…”

Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis

“…As mentioned above, HCV GT3‐infected patients with concomitant cirrhosis and/or prior HCV treatment experience have historically been the most difficult patients to cure . In the phase 3 study SURVEYOR‐2 Part 3, 98% (39/40) of treatment‐naïve patients with HCV GT3 infection and compensated cirrhosis achieved SVR12 after 12 weeks of G/P . Based in part on these findings, AASLD and EASL recommend 12 weeks of G/P for treatment‐naïve patients with compensated cirrhosis.…”