Effectiveness of glecaprevir/pibrentasvir in HIV/HCV-coinfected patients treated with bictegravir/emtricitabine/tenofovir alafenamide.

Abstract

Aim of the study: To assess the real-life efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in HIV/HCV- positive patients treated with bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF).

Material and methods: Patients were evaluated in terms of their baseline biochemical characteristics, which included platelet count, serum creatinine and bilirubin levels, alanine transaminase (ALT) activity, international normalized ratio (INR) and Model for End-Stage Liver Disease (MELD) score.The efficacy endpoint was the achievement of a sustained virologic response at posttreatment week 12 (SVR12), defined as undetectable HCV RNA 12 weeks after the scheduled end of therapy.

Results: No significant differences in baseline patient characteristics between the two study groups were observed. Patients treated with sofosbuvir/velpatasvir (SOF/VEL) were more often treatment-naïve, but the difference was not statistically significant (96.0% vs. 86.8% in GLE/PIB group, p = 0.0629). Prevalence of genotype 3 was higher in the group treated with GLE/PIB (36.9% vs. 21.8% in SOF/VEL group, p = 0.183382), while genotype 1 was more frequent in patients treated with SOF/VEL (55.4% vs. 44.7% in GLE/PIB group, p = 0.348202), but again it did not prove to be statistically significant. SVR12 rates reached 78.9% and 80.2% for GLE/PIB and SOF/VEL, respectively, in ITT analysis, and 100% and 98.8%, respectively, in modified intent-to-treat (mITT) analysis.

Conclusions: The study showed that real-life results of direct acting antiviral (DAA) therapy with GLE/PIB or SOF/VEL did not differ significantly in HIV/HCV-coinfected patients treated with B/FTC/TAF. Both regimens allowed encouraging SVR12 rates and treatment safety to be achieved, as well as tolerability, which was also comparable between the study groups.