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.


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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.

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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.

Reference

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.