In treatment-naive patients with hepatitis C virus (HCV), 8 weeks of treatment with glecaprevir/pibrentasvir is efficacious and well tolerated, according to data published in Clinical Gastroenterology and Hepatology.
Investigators performed an integrated analysis of pooled data from 8 phase 2 or phase 3 trials of treatment-naive patients with HCV genotype 1 through 6 but without cirrhosis or with compensated cirrhosis. In these trials, 1248 patients received 8 weeks of glecaprevir/pibrentasvir, and the overall safety and efficacy was evaluated.
Of the total patients, 27% had cirrhosis (80% white; median age 54 years). Genotype 1 and 3 were most common, with 47% of infections attributed to genotype 1 and 22% genotype 3. At 12 weeks post-treatment, the overall rates of sustained virologic response (SVR) were 97.6% in the intention to treat (ITT) and 99.3% in the modified ITT populations. When patients with genotype 3 infection and compensated cirrhosis where excluded, rates of SVR at 12 weeks post-treatment were 97.6% in the ITT and 99.4% in the modified ITT populations.
In the ITT population, 8 virologic failures occurred: 7 in patients without cirrhosis and 1 in a patient with cirrhosis. Virologic failure was not associated with markers of advanced liver disease or with populations of interest, including those with current alcohol use, opioid substitution therapy, history of injection drug use, and severe renal impairment. The occurrence of treatment-emergent adverse events was observed in 58% of patients, with the most frequent adverse events (>10%), including headache and fatigue, both of which occurred in 12% of patients. Both serious adverse events and adverse events that led to treatment discontinuation were reported in 2% and <1% of patients, respectively.
Investigators noted that, as this was a post-hoc analysis, it does not have the statistical power to compare patient groups. Additionally, not all the studies included in the analysis reported the same data. A third limitation was the low number of patients in some subgroups, such as patients with recent injection drug use and patients with genotype 5 infection.
According to investigators, these results do demonstrate that treatment with glecaprevir/pibrentasvir for 8 weeks is “efficacious in treating treatment-naive patients, who comprise the current majority of infected patients with HCV.”
Furthermore, the researchers believe there would be little benefit in attempting to find negative predictors or a subpopulation with low SVR due to the high overall modified ITT SVR rates at week 12 and the very low number of virologic failures. This then adds to evidence that this treatment course potentially simplifies pre-treatment assessment.
“The short treatment duration may help the effort to improve patient adherence to treatment, reduce treatment burden, and support elimination efforts,” the researchers concluded.
Disclosure: This clinical trial was supported by AbbVie. Please see the original reference for a full list of authors’ disclosures.
Zuckerman E, Gutierrez JA, Dylla DE, et al. Eight weeks of treatment with glecaprevir/pibrentasvir is safe and efficacious in an integrated analysis of treatment-naïve patients with hepatitis C virus infection [published online July 1, 2020]. Clin Gastroenterol Hepatol. doi:10.1016/j.cgh.2020.06.044