An updated systematic review and meta-analysis on efficacy of Sofosbuvir in treating hepatitis C-infected patients with advanced chronic kidney disease

Abstract

Sofosbuvir seems to be a revolutionary treatment for Hepatitis C-infected patients with advanced chronic kidney disease (CKD) but existing evidence is not quite adequate. The aim of this study was to evaluate the efficacy and safety of Sofosbuvir-based therapy without Ribavirin for all hepatitis C virus genotypes among patients with advanced CKD. We conducted an updated systematic literature search from the beginning of 2013 up to June 2020. Sustained virologic response (SVR) rate at 12 and/or 24 weeks after the end of treatment, and adverse events in HCV-infected patients with advanced CKD were pooled using random effects models. We included 27 published articles in our meta-analyses, totaling 1,464 HCV-infected patients with advanced CKD. We found a substantial heterogeneity based on the I2 index (P = 0.00, I2 = 56.1%). The pooled SVR rates at 12 and 24 weeks after the end of Sofosbuvir-based treatment were 97% (95% Confidence Interval: 95–99) and 95% (89–99) respectively. The pooled SVR12 rates were 98% (96–100) and 94% (90–97) in patients under 60 and over 60 years old respectively. The pooled incidence of severe adverse events was 0.11 (0.04–0.19). The pooled SVR12 rate after completion of the half dose regimen was as high as the full dose treatment but it was associated with less adverse events (0.06 versus 0.14). The pooled SVR12 rate was 98% (91–100) in cirrhotic patients and 100% (98–100) in non-cirrhotic patients. The endorsement of Sofosbuvir-based regimen can improve the treatment of hepatitis C virus infection in patients with advanced CKD.

The Efficacy and Safety of Sofosbuvir/Daclatasvir Fixed-Dose Combination in Iranian Hemodialysis Patients with Hepatitis C Virus Infection

“…Poustchi et al (23) pointed out that even though there was no pharmacokinetic data indicating plasma level of SOF, administration of SOF/DCV in Iranian hemodialysis patients with HCV infection and renal impairment was proved to be safe without observation of any serious adverse event, which is in line with our results. A metaanalysis (24) showed that SOF-based regimens are effective, with a 97% SVR12 rate, in patients with advanced CKD. In this meta-analysis, the efficacy of SOF/DCV in patients with advanced CKD was 97%, which is consistent with the results of the current study (24).…”

“…A metaanalysis (24) showed that SOF-based regimens are effective, with a 97% SVR12 rate, in patients with advanced CKD. In this meta-analysis, the efficacy of SOF/DCV in patients with advanced CKD was 97%, which is consistent with the results of the current study (24). Dual administration of DCV and SOF daily demonstrated a noticeable effect in the course of 12-week treatment in HCV patients.…”

The Role of Gastroenterologists in Preoperative Assessment and Management of Prospective Renal Transplantation Candidates

“…Renal clearance is the major elimination pathway for GS-331007, the dephosphorylation-derived nucleoside metabolite of sofosbuvir, and was initially not recommended for patients with severe renal impairment (eGFR <30 mL/minute/1.73m 2 ) or ESRD. However, two meta-analyses of studies on the outcome of the sofosbuvir-based regimen in stage 4–5 CKD 58 , 59 showed a pooled SVR12 rate of 97% with an 11–12% average pooled incidence of adverse effects. Thus, dialysis and advanced renal disease do not require a dose adjustment of DAAs.…”

Severe impairment of patient‐reported outcomes in patients with chronic hepatitis C virus infection seen in real‐world practices across the world: Data from the global liver registry

“…These new treatments, direct‐acting antivirals (DAAs), are now administered as an all‐oral, interferon‐free regimen covering all HCV genotypes 1,2 . The DAA regimens have also proven to be efficacious in multiple chronic hepatitis C (CHC) subpopulations including those with cirrhosis, HIV, and with other liver diseases 1–7 …”

“…1,2 The DAA regimens have also proven to be efficacious in multiple chronic hepatitis C (CHC) subpopulations including those with cirrhosis, HIV, and with other liver diseases. [1][2][3][4][5][6][7] In addition to providing clinical benefit, DAA-based treatment for CHC has been shown to significantly improve health-related quality of life and other patient-reported outcomes (PROs) which can occur as early as 2-4 weeks after starting treatment even in the presence of advanced liver disease. [8][9][10] The economic benefit of treating all patients with DAAs, especially earlier in their disease course, is also substantial.…”