Ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin (OBV/PTV/r±DSV±RBV) is effective for achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) genotypes 1a, 1b, or 4, according to results published in the Journal of Viral Hepatitis.
The study included data from observational studies spanning 13 countries. Participants were treatment-naive or treatment-experienced, with and without cirrhosis (n=3808). They received OBV/PTV/r±DSV±RBV according to approved local labels and clinical practices. The researchers assessed SVR at week 12 (SVR12), adverse events (AEs), and comedication management among participants who initiated treatment before June 1, 2017.
Of all participants, 19% (n=732) had HCV GT1a, 69% (n=2619) had GT1b, and 12% (n=457) had GT4.
At week 12 posttreatment, 3546 participants had sufficient follow-up data. Among these participants, the SVR12 rate was 96% (n=3401). Participants with or without cirrhosis had comparable rates of SVR12 (96%).
By HCV genotype, SVR12 rates were 93% for GT1a, 97% for GT1b, and 94% for GT4.
Comedications for peptic ulcers, gastroesophageal reflux disease, statins, antipsychotics, or antiepileptics were used by 58% of participants and had a minimal effect on SVR12.
AEs occurred in 26% of participants, with the most common being anemia and fatigue. Serious AEs occurred in 3% of participants, including anemia, hepatic failure, hepatocellular carcinoma, and jaundice. The discontinuation rate was <4%.
“The high degree of concordance observed between our real-world data and the results from pivotal clinical trials suggests that the reported efficacy of OBV/PTV/r±DSV±RBV regimens in clinical trials translates to routine clinical practice,” the researchers wrote.
AbbVie sponsored the study; contributed to its design, and participated in the collection, analysis, and interpretation of the data and in the writing, reviewing, and approval of the publication. All authors had access to all relevant data and participated in the writing, review, and approval of this manuscript.
Ferenci P, Bourgeois S, Buggisch P, et al. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: a pooled analysis of post-marketing observational studies from 13 countries [published online February 10, 2019]. J Viral Hep. doi: 10.1111/jvh.13080.