Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

Abstract

Background Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan. Methods Between July 2019 and March 2020, 1,880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR 12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported. Results The SVR 12 rates by EP and PP analyses were 95.6% (1,798 of 1,880 patients; 95% con dence interval (CI): 94.6%-96.5%) and 99.3% (1,798 of 1,811 patients; 95% CI: 98.8%-99.6%), respectively. Among 82 patients who failed to achieve SVR 12 , 13 (15.9%) were attributed to virologic failures. The SVR 12 rates were comparable regardless of baseline characteristics. A total of 1,859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations. Conclusions SOF/VEL for 12 weeks is e cacious and well-tolerated chronic HCV-infected patients with compensated liver disease in Taiwan.

Sofosbuvir/Velpatasvir for Hepatitis C Virus Infection: Real-World Effectiveness and Safety from a Nationwide Registry in Taiwan

“…Although there have been some real-world analyses on the use of SOF/VEL in Taiwan published recently, there is still a gap in data available. The studies that have been published to date have reported high SVR12 rates (between 98% and 100%) [ 19 , 21 ]. A study using the TACR database previously investigated the efficacy of SOF/VEL, reporting SVR12 rates of 99%.…”

Hepatitis C Virus Reinfection in People With HIV in Taiwan After Achieving Sustained Virologic Response With Antiviral Treatment: The RECUR Study

“…Currently, data are not available concerning the screening and treatment rates for HCV among HIV-positive MSM patients in Taiwan. Studies have shown that the SVR 12 rates in HIV-positive patients in Taiwan with pangenotypic sofosbuvir/velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB) range from 97.1% to 98.2% and are comparable to the response rates in the usual population [ 39 , 41 , 42 ]. By increasing patient awareness, mass screening, point-of-care testing, and link-to-care programs, the HCV reservoir in at-risk populations could be efficiently controlled.…”

Sexually-transmitted hepatitis C virus reinfections among people living with HIV in Taiwan: the emerging role of genotype 6

“…In Taiwan, studies before 2005 universally demonstrated a very low prevalence of HCV genotype 6 in the general population [ 31 , 32 ]. After the outbreak of HIV and HCV among IDUs in 2005, studies have shown that the seroprevalence of HCV genotype 6 had increased to 5%–10% in the general population [ 33 , 34 ]. In terms of PLWH, the prevalence of HCV genotype 6 was around 20%–30%, which also was likely associated with IDUs who had HIV coinfection [ 35–37 ].…”