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The integrated analysis of two phase 3 clinical trials evaluating the safety and efficacy of glecaprevir/pibrentasvir in patients with hepatitis C virus (HCV) coinfected with HIV-1 found an overall sustained virologic response of 98% at 12 weeks of treatment in individuals with or without cirrhosis, according to data presented at IDWeek 2018, held October 3 to 7, 2018, in San Francisco, California.
Patients included in this analysis were ≥18 years of age with a body mass index ≥18 kg/m2 and who had chronic HCV infection with genotype 1, 2, 3, 4, 5, or 6 (HCV RNA ≥1000 IU/mL). Participants were either treatment naïve for HCVinfection or had been treated with interferon, peginterferon with or without ribavirin, or sofosbuvir plus ribavirin with or without peginterferon. The exception was patients with HCV genotype 3, none of whom had a history of being treated for HCV. Participants also had a positive test result for anti-HIV-1 antibody, had not received antiretroviral therapy (ART), and had a CD4+ count of ≥500 cells/mm3 or ≥29% or were on a stable ART regimen for at least 8 weeks prior to screening, with CD4+ count ≥200 cells/mm3 or ≥14% and plasma HIV-1 RNA less than the lower limit of quantification.
A total of 152 patients without cirrhosis received 8 weeks of glecaprevir/pibrentasvir treatment and 16 individuals with cirrhosis received 12 weeks of treatment. Overall, the sustained virologic response at 12 weeks posttreatment was 98% with no relapses in patients coinfected with HCV/HIV-1 with or without cirrhosis. For patients without cirrhosis, 8 weeks of glecaprevir/pibrentasvir treatment resulted in a sustained virologic response at 12 weeks posttreatment of 99.3%, with no virologic failures. High baseline viral load, presence of baseline polymorphisms, cirrhosis status, or other baseline factors had no impact on achievement of sustained virologic response at 12 weeks posttreatment. The glecaprevir/pibrentasvir treatment was also well tolerated, with rare serious adverse events or clinically significant laboratory result abnormalities. Further, all patients on stable ART maintained HIV-1 RNA suppression throughout the study.
Investigators concluded that glecaprevir/pibrentasvir is safe and well tolerated and the results support glecaprevir/pibrentasvir as the first HCV regimen recommended for 8 weeks in all major HCV genotypes for patients coinfected with HIV without cirrhosis.
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Rockstroh J, Bhagani S, Orkin C, et al. Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotypes 1-6 and human immunodeficiency virus-1 coinfection: an integrated analysis of two phase 3 clinical trials. Presented at: IDWeek 2018; October 3-7, 2018; San Francisco, CA. Abstract 1965.