This article first appeared on our sister site HCPLive.
Eight weeks of glecaprevir/pibrentasvir (G/P) in adults and adolescents with previously untreated acute hepatitis C virus (HCV) infection, according to a study presented at the AMA Liver Meeting 2023 Treatment sessions are a safe and effective method of treatment. Association for the Study of Liver Diseases. Treatment demonstrated a virological response at week 12 (SVR12) that was better than the previous efficacy threshold.
Although the trial did not reach the protocol-specified number of patients in the primary safety stratum (PSS) analyzing liver safety, no new safety signals were observed in patients with acute HCV compared with the chronic HCV population.
“There are currently no direct-acting antivirals (DAAs) approved for the treatment of acute hepatitis C virus infection, leading to treatment delays,” wrote lead researcher Stanislas Pol, MD, professor of hepatology. , increased loss to follow-up and further transmission of hepatitis C virus.” Gastroenterology, Sorbonne University, Paris, France. “This gap in standards of care affects vulnerable groups such as people who inject drugs (PWID).
what you should know
The study found that an 8-week course of G/P therapy was safe and effective in adults and adolescents with previously untreated acute HCV infection.
Although the trial did not reach the primary safety tier (PSS) protocol-specified number of patients, no new safety signals were observed in patients with acute HCV compared with the chronic HCV population.
This study highlights gaps in the current standard of care for acute HCV infection and highlights the lack of approved direct-acting antivirals (DAAs) for this population.
This retrospective, noninterventional, single-arm patient chart review study evaluated the effectiveness and safety of an 8-week G/P intervention in patients with acute HCV infection in 7 countries. Data were obtained from 6 months before the first G/P dose to 24 weeks after treatment. Eligible patients had acute HCV infection, were ≥12 years of age, had no history of liver or kidney transplantation or liver decompensation, and had not received HCV treatment for current infection. Information was assessed at baseline and during treatment.
The primary efficacy endpoint was SVR12 in the modified complete analysis set (mFAS), excluding non-virological failure, compared to an efficacy threshold defined as 92.6% based on the G/P SVR12 rate from previous chronic HCV trials. Other efficacy endpoints include on-treatment virological failure (OTVF) and recurrence and reinfection of FAS. Safety endpoints were adverse events (AEs) and alanine aminotransferase (ALT). Efficacy was assessed using HCV ribonucleic acid (RNA) data.
A total of 202 patients participated in the FAS assessment, the majority (85.1%) of whom were male, 88.6% were white, 98.6% were noncirrhotic, 68.5% had no previous HCV infection, 51.3% had HIV co-infection, and 54.1% were Non-cirrhotic patients. % is HCV genotype 1.
The mFAS population was reported to be better than the efficacy threshold (99.3%; 95% confidence interval (CI) (96.3 – 99.9)), with 1 subject experiencing relapse after treatment. SVR12 rates were lower in FAS compared with the historical comparison group, primarily due to the lack of SVR12 data in FA. There were no AEs related to treatment discontinuation and no AEs of decompensation of liver failure were reported. Regarding AEs, 2 patients experienced serious AEs; however, they were not related to G/P treatment. No participant had an ALT increase of ≥2 grades that worsened from baseline during treatment. All incidence rates were comparable to the chronic hepatitis C control cohort.
During treatment, all patients with ALT grade ≥2 at baseline improved to grade 0/1 according to PSS (n = 42/42) and FAS (n = 53/53). Of the 6 patients with total bilirubin grade ≥2 at baseline, 5 improved to grade 0/1. One patient who was grade 4 at baseline improved to grade 2 during the trial.
The researchers noted that insufficient patient enrollment to assess safety and a retrospective real-world study with insufficient follow-up data limited the findings.
“These data support further clinical investigation of an 8-week G/P regimen for acute HCV to shorten the care cascade and reduce further transmission of HCV and help achieve HCV elimination,” the researchers concluded.
refer to
Pol S, Thompson A, Collins M, Venier E, et al. Efficacy and safety of 8 weeks of Glecaprevir/Pibrentasvir in patients with acute hepatitis C: a single-arm retrospective study. Paper presented at: AASLD Liver Meeting, November 10-14, 2023. Accessed November 22, 2023.