Glecaprevir/Pibrentasvir Effective for Chronic HCV Infection With CKD

For patients with chronic hepatitis C virus (HCV) infections and chronic kidney disease (CKD), treatment with glecaprevir/pibrentasvir (GLE/PIB) was both effective and well-tolerated for 8 to 12 weeks, according to data published in the Journal of Viral Hepatitis.

Because of the limited data regarding the effectiveness and safety of GLE/PIB in patients with HCV and severe renal impairment, investigators retrospectively enrolled 108 patients with chronic HCV with CKD. Of these, 32 had stage 4 CKD and 76 had stage 5, and all received GLE/PIB for 8 to 12 weeks. Safety profiles were assessed and effectiveness determined by sustained virologic response at off-therapy week 12 (SVR₁₂) for evaluable (EP) and per protocol (PP) populations.

The SVR₁₂ rate according to EP and PP was 99.1% (95% CI, 94.9%-99.8%) and 100% (95% CI, 96.5%-100%), respectively. In patients with stage 4 or 5 CKD, SVR₁₂ rates were 100% (95% CI, 89.3%-100%) and 98.7% (95% CI, 92.9%-99.8%), respectively. A single patient who declined off-therapy follow-up after permanently discontinuing treatment at week 9 because of a scheduled cardiac surgery had nonvirologic failure.

Sixteen patients had serious adverse events; however, none of these was deemed to be related to GLE/PIB. The 3 most common adverse events were pruritus (19.4%), fatigue (15.7%), and nausea (13.9%). No patients had ≥3-fold upper limit of normal for total bilirubin and alanine aminotransferase levels. Of 9 patients in the trial who were co-infected with hepatitis B, none developed hepatitis B-associated hepatitis.

This study recruited a sizeable number of patients with HCV and CKD stage 4 and 5, and provided more robust evidence for the use of GLE/PIB. However, it was not without limitations, including that 95.4% of patients were infected with HCV genotype 1 and/or 2 and the data regarding GLE/PIB for 16 weeks were limited. Therefore, more data on HCV genotype 3 to 6 and on patients receiving 16 weeks of treatment are needed. Patients were recruited from tertiary centers, so results on effectiveness and safety cannot be confirmed for patients with stage 4 and 5 CKD at community hospitals or local clinics. Also, investigators did not assess the proportions of HCV RNA less than lower limit of quantification at on-treatment week 4 or evaluate whether early viral kinetics would affect the SVR₁₂ rates. Finally, it is possible that there are reporting biases with regard to the proportions and the grade of adverse events as a result of the retrospective nature of the study, which lacked standardized case reports.

According to the investigators, “compared to [genotype]-specific [direct acting antiviral agent] regimens, the pangenotypic GLE/PIB can simplify the HCV care by abolishing the need for HCV [genotype] testing.” Their results here demonstrate that this treatment is effective and well-tolerated in patients with chronic HCV with stage 4 or 5 CKD.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Liu CH, Yang SS, Peng CY, et al. Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection and severe renal impairment [published online January 25, 2020]. J Viral Hepat. doi:10.1111/jvh.13265