No abstract

Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).

clinicaltrials.gov Identifier: NCT01939197.

Well‐tolerated, ribavirin‐free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once‐daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment (SVR12) across all major HCV genotypes (GTs). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1‐6 infection who had received a liver or kidney transplant. MAGELLAN‐2 was a phase 3, open‐label trial conducted in patients who were ≥3 months posttransplant. Patients without cirrhosis who were HCV treatment‐naive (GT1‐6) or treatment‐experienced (GT1, 2, 4‐6; with interferon‐based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver transplant and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0‐F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N = 98/100; 95% confidence interval, 95.3%–100%), which exceeded the prespecified historic standard‐of‐care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity, and laboratory abnormalities were infrequent. Conclusion: Once‐daily glecaprevir/pibrentasvir for 12 weeks is a well‐tolerated and efficacious, ribavirin‐free treatment for patients with chronic HCV GT1‐6 infection who have received a liver or kidney transplant. (http://ClinicalTrials.gov NCT02692703.) (Hepatology 2018; 00:000‐000).

No abstract

The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.

Glecaprevir/pibrentasvir is approved to treat hepatitis C virus genotype 1–6 infection. Patients coinfected with human immunodeficiency virus type 1 achieved high cure rates after 8- (without cirrhosis) and 12- (compensated cirrhosis) week treatment, without adjustments to antiretroviral therapy regimens.NCT02738138.

No abstract