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Stephen Padilla, 24 Jan 2020
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Glecaprevir-pibrentasvir: Wonder combo for HCV patients with severe renal impairment

Jairia Dela Cruz
03 Apr 2019

The use of glecaprevir plus pibrentasvir appears to be safe and highly effective in the treatment of chronic hepatitis C virus (HCV) infection genotypes 1–3 in patients with severe renal impairment, including those undergoing haemodialysis, as shown in a recent study from Japan.

“Haemodialysis was associated with increased incidence of pruritus, which was the most frequent adverse event, but exerted little or no influence on the concentrations of [the study drugs], which indicated that their dialysability is very low and that no dose modification is required in patients undergoing haemodialysis,” the investigators said.

The present prospective multicentre study involved 832 chronic HCV genotype 1–3 patients with chronic kidney disease (CKD) who received treatment with glecaprevir/pibrentasvir for 8 or 12 weeks. Of these, 141 patients (median age, 68 years; 71.6 percent male) had CKD stage 4 (n=32) or stage 5 (n=109). A total of 100 patients were undergoing haemodialysis.

The overall sustained virologic response (SVR) rate in the CKD 4–5 group was high at 99.3 percent (140/141). The sole patient who relapsed after treatment had genotype 2b and stage 5 disease. All 41 patients with cirrhosis achieved SVR. [Aliment Pharmacol Ther 2019;doi:10.1111/apt.15218]

A total of 56 patients (39.7 percent) reported adverse events, with pruritus being the most common (30.5 percent) and significantly associated with haemodialysis. No deaths or serious adverse events occurred.

The results of the pharmacokinetic study revealed no arterial‐venous differences in the plasma concentrations of the study drugs during the haemodialysis sessions, the investigators noted. “Therefore, the SVR rate for patients undergoing haemodialysis (99/100; 99.0 percent) was as high as that for patients not undergoing haemodialysis (728/732; 99.4 percent).”

Furthermore, in stage 4 or 5 CKD patients not undergoing haemodialysis, eGFR levels did not significantly change between the baseline and end of 8‐week (median, 20.8 vs 20.0 mL/min/1.73 m2) or 12-week treatment course (median, 16.4 vs 15.7 mL/min/1.73 m2; p=0.728), indicating the safety of glecaprevir/pibrentasvir for patients with severe renal impairment not undergoing haemodialysis.

“The administration of glecaprevir/pibrentasvir for the treatment of chronic HCV is characterized as an interferon‐free, ribavirin‐free and pan‐genotypic regimen,” according to the investigators.

Other drug combinations (eg, elbasvir/grazoprevir, sofosbuvir/ribavirin, or ombitasvir/paritaprevir plus ritonavir plus ribavirin) for HCV infection used in patients with the complication of CKD have limited genotype coverage or are not recommended for those with severe renal impairment. [J Gastroenterol Hepatol 2019;34:364-369; Lancet Gastroenterol Hepatol 2017;2:585‐594; Hepatology 2015;62:1037‐1046; Dig Liver Dis 2017;49:1029‐1035]

“Thus, glecaprevir/pibrentasvir could be highly effective and safe for genotype 2 patients with chronic kidney disease,” they said.

“One limitation of this study was that genotype 4–6 patients were not included. However, as glecaprevir/pibrentasvir is pan‐genotypic drug, it may be effective and safe even for genotype 4–6 patients with severe renal impairment,” they added.

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Stephen Padilla, 24 Jan 2020
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