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.
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