Combination sofosbuvir/velpatasvir treatment can be highly efficacious in treating hepatitis C virus (HCV) infection in patients coinfected with HIV, according to research results to be presented at the virtual Conference on Retrovirus and Opportunistic Infections, held from March 8 to 11, 2020.
Sofosbuvir and velpatasvir are direct-acting antiviral agents (DAAs) against HCV with pan-genotypic activity and a high barrier to resistance. However, there is scant real-world data to support the efficacy of these DAA in the treatment of chronic HCV.
Therefore, researchers sought to evaluate the safety and effectiveness of sofosbuvir/velpatasvir in a prospective registry of patients with HCV infection with and without HIV coinfection, who were receiving DAA agents for HCV. The primary endpoint was 12-week sustained viral response, assessed via intention-to-treat and modified intention-to-treat analyses; secondary endpoints included viral relapse, viral breakthrough, and treatment discontinuation due to adverse events or other reasons.
The investigators identified 22,903 patients with HCV infection who were eligible for inclusion; key inclusion criteria included once-daily treatment with combination sofosbuvir/velpatasvir (1 tablet; total dose 400 mg/100 mg) for HCV and a scheduled treatment conclusion on or before February 1, 2019. Patients who underwent retreatment after all-oral DAA agents were excluded from the study.
In total, 1003 of the 22,903 patients (median age 55 years; 61.1% men) met the inclusion criteria: 888 with HCV monoinfection and 115 with HIV/HCV coinfection. In each group, 10.2% and 10.4%, respectively, had received prior anti-HCV therapy.
In the intention-to-treat analysis, patients with HCV monoinfection had a sustained viral response of 95.7% (95% CI, 94.2-97.0) and experienced relapse at a rate of 1.6%. Two and 21 patients discontinued treatment due to adverse events or other reasons, respectively, and 1 death was reported. Among patients with HCV/HIV coinfection, patients experienced a sustained viral response of 93.0% (95% CI, 86.8-96.9) and a relapse rate of 2.6%. No patients discontinued due to adverse events, while 4 discontinued for other reasons. One death was reported.
In the modified intention-to-treat population, sustained viral responses of 98% and 96.4% in the mono- and co-infected populations, respectively, were seen. Discontinuation rates due to adverse events were low in both groups, and only 1 death was reported in each cohort.
HIV status, and genotype of HCV infection demonstrated no significant effect on the development of sustain viral response; modified intention-to-treat analysis showed sustained viral response in 96.4% of patients with HIV/HCV coinfection, and 98% of those with HCV only; P = .261). Among patients with HCV infection with genotype 1, 2, 3, and 4 demonstrated sustained viral responses 98.5%, 98.2%, 97.2%, and 97.3%, respectively.
Patients were also analyzed based on liver disease severity. Across both the intention-to-treat and modified intention-to-treat populations, patients with no cirrhosis fared better than those with decompensated cirrhosis (sustained viral response, 96.1% vs 87.2% and 98.5% vs 91.9%, respectively).
“In this large cohort of patients with hepatitis C…treatment with [sofosbuvir/velpatasvir] was highly efficacious across all genotypes and in the presence of HIV. Response was significantly poorer in patients with decompensated cirrhosis than in patients without cirrhosis,” the researchers concluded.
Aldámiz-Echevarria T, Berenguer J, Gil Á, et al. Real-world effectiveness of sofosbuvir/velpatasvir for hepatitis C virus infection. Poster presented at: CROI 2020; March 8-11, 2020; http://www.croiconference.org/sites/default/files/uploads/croi2020-boston-abstract-ebook.pdf. Accessed March 19, 2020.