Patients with chronic hepatitis C virus (HCV) and severe renal impairment treated with sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) achieve a sustained virological response (SVR) without worsening renal damage, according to a study published in Gut.
Because SOF is excreted extensively by the kidneys and has been deemed unsafe for chronic kidney disease (CKD) patients in previous trials, this is the first large multicenter study on SOF/VEL for patients with CKD.
Investigators aimed to assess sustained virological response at off-treatment week 12 (SVR12) in adult patients whom they retrospectively recruited between July 2019 and March 2020. These patients had chronic HCV, stage 4 or 5 CKD, and were being treated with SOF/VEL with or without low-dose RBV.
Patients with compensated liver disease received SOF 400mg and VEL 100 mg daily for 12 weeks. Patients with decompensated liver disease received SOF/VEL plus RBV 200 mg daily for 12 weeks.
Virological failure was defined as HCV ribonucleic acid levels greater than the lower limit of quantitation (LLOQ) at off-treatment week 12, and nonvirological failure was defined as no available SVR12 data. Results were designed to include the evaluable population (EP) who received at least 1 dose of treatment and the per-protocol population (PP) who had available SVR12 data.
Of the 191 patients included in the study, 181 had compensated liver disease and 10 had decompensated liver disease. Of the 187 with available data at on-treatment week 12, all had serum HCV levels below LLOQ.
The SVR12 rates by EP and PP analyses were 94.8% (181/191; 95% CI, 90.6-97.1) and 100% (181/181; 95% CI, 97.9-100). The SVR12 rates in patients with compensated liver disease by EP and PP analyses were 95% (172/181; 95% CI, 90.8-97.4) and 100% (172/172; 95% CI, 97.8-100). The SVR12 rates in patients with decompensated liver disease by EP and PP analyses were 90% (9/10; 95% CI, 59.6-98.2) and 100% (9/9; 95% CI, 70.1-100). The 10 patients who failed to achieve SVR12 had nonvirological causes.
There were 119 patients (62.3%) who reported at least 1 adverse event. There were 20 patients (10.5%) who reported serious adverse events, none of which were judged related to SOF/VEL or RBV.
The mean eGFR level of 56 patients with stage 4 CKD at baseline was 25.5 mL/min/1.73 m2 (standard deviation [SD], 3.3) and 27.0 mL/min/1.73 m2 (SD, 6.1) at SVR12. The mean eGFR level of 11 patients with stage 5 CKD not on dialysis at baseline was 7.3 mL/min/1.73 m2 (SD, 3.3) and 7.0 mL/min/1.73 m2 (SD, 3.3) at SVR12 (P =.65).
No patients with HCV genotypes 4 or 5 and few with genotypes 1a or 3 were included in the study.
The authors noted that SOF/VEL, a pan-genotypic direct-acting antiviral, simplifies HCV care by eliminating the need for genotype testing and, unlike protease inhibitor-based regimens, is cost-effective for patients because it can be used in those with compensated or decompensated liver disease.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of the authors’ disclosures.
Liu CH, Chen CY, Su WW, et al. Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment. Gut. Published online January 6, 2021. doi:10.1136/gutjnl-2020-323569