Glecaprevir-pibrentasvir combo safe, effective for HCV
25 May 2020
While there are several clinical signs of the infection such as fatigue, joint pain and jaundice – a majority of patients with the virus remain largely asymptomatic.The combination of glecaprevir and pibrentasvir is effective and well-tolerated across all genotypes of hepatitis C virus (HCV), according to a recent meta-analysis of real-world data.
Researchers retrieved 18 studies from the databases of BIOSIS, Derwent Drug File, Embase, International Pharmaceutical Abstracts, Medline and SciSearch. The resulting pooled sample included 12,531 adults with chronic HCV. Endpoints were efficacy and safety.
The efficacy of glecaprevir/pibrentasvir was assessed using 12-week sustained virological response (SVR12) in 8,583 patients (15 studies). The overall rate was 96.7 percent in the intention-to-treat (ITT) population and 98.1 percent in the modified ITT population. In those with and without cirrhosis, the ITT SVR12 rates were 97.8 percent and 97 percent, respectively.
Treatment duration likewise did not seem to have a significant influence on treatment efficacy, with 8-week and 12-week regimens yielding high SVR12 rates (96.5 percent and 96.0 percent, respectively).
In treatment-naïve patients without cirrhosis, on-label glecaprevir/pibrentasvir likewise yielded a good SVR12 rate of 98.2 percent after 8 weeks of treatment.
The combination treatment was likewise relatively safe. In 7,199 patients for whom side-effect data were available, only 17.7 percent (n=1,271) patients experienced adverse events (AEs). No AE had a frequency exceeding 5 percent; the most common AE was pruritus, reported in 4.7 percent of the sample.
Other common side effects were fatigue and headaches. Fifty-five patients developed serious AEs and one had a severe AE. Thirty-three needed to discontinue treatment due to side effects.