scholarly journals Use of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus infection and severe renal impairment

2020 ◽  
Vol 26 (4) ◽  
pp. 554-561
Author(s):  
Desmond Y. H. Yap ◽  
Kevin S. H. Liu ◽  
Yu-Chun Hsu ◽  
Grace L. H. Wong ◽  
Ming-Chang Tsai ◽  
...  

Background/Aims: Data on treatment efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) for chronic hepatitis C virus (HCV) infection in Asian patients with severe renal impairment are limited. This study aimed to study the treatment and side effects of GLE/PIB in these patients infected with non-1 genotype (GT) HCV.Methods: We prospectively recruited patients with Child’s A cirrhosis and eGFR <30 mL/min/1.73 m<sup>2</sup> in Hong Kong and Taiwan during 2017–2018 to receive GLE/PIB treatment.Results: Twenty-one patients (GT2, n=7; GT3, n=6; and GT6, n=8) received GLE/PIB for 11.2±1.8 weeks. All except one were treatment-naïve. GLE/PIB was initiated in 16 patients while on dialysis (seven on peritoneal dialysis [PD] and nine on hemodialysis) and in five patients before dialysis. One patient died of PD-related peritonitis during treatment and two were lost to follow up. The SVR12 rate in the remaining 18 patients was 100%. All patients achieved undetectable levels at 4-, 12-, 24- and 48-week after treatment. Patients with deranged alanine aminotransferase showed normalization after 4 weeks and the response was sustained for 48 weeks. No significant adverse event was observed.Conclusions: GLE/PIB treatment was associated with high efficacy and tolerability in HCV-infected patients with severe renal impairment.

2020 ◽  
Vol 27 (6) ◽  
pp. 568-575 ◽  
Author(s):  
Chen‐Hua Liu ◽  
Sheng‐Shun Yang ◽  
Cheng‐Yuan Peng ◽  
Woan‐Tyy Lin ◽  
Chun‐Jen Liu ◽  
...  

Gut ◽  
2021 ◽  
pp. gutjnl-2020-323569
Author(s):  
Chen-Hua Liu ◽  
Chi-Yi Chen ◽  
Wei-Wen Su ◽  
Kuo-Chih Tseng ◽  
Ching-Chu Lo ◽  
...  

ObjectiveData regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited. We evaluated the performance of SOF/VEL with or without low-dose RBV in HCV-infected patients with chronic kidney disease stage 4 or 5.Design191 patients with compensated (n=181) and decompensated (n=10) liver diseases receiving SOF/VEL (400/100 mg/day) alone and SOF/VEL with low-dose RBV (200 mg/day) for 12 weeks were retrospectively recruited at 15 academic centres in Taiwan. The effectiveness was determined by sustained virological response at off-treatment week 12 (SVR12) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed.ResultsThe SVR12 rates by EP and PP analyses were 94.8% (95% CI 90.6% to 97.1%) and 100% (95% CI 97.9% to 100%). In patients with compensated liver disease, the SVR12 rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR12 rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR12 were attributed to non-virological failures. Among the 20 serious adverse events (AEs), none were judged related to SOF/VEL or RBV. The AEs occurring in ≥10% included fatigue (14.7%), headache (14.1%), nausea (12.6%), insomnia (12.0%) and pruritus (10.5%). None had ≥grade 3 total bilirubin or alanine aminotransferase elevations.ConclusionSOF/VEL with or without low-dose RBV is effective and well-tolerated in HCV-infected patients with severe RI.


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