July 11, 2013

Renal impairment common with telaprevir, boceprevir therapy for HCV

Provided by Healio

Mauss S. Hepatology. 2013;doi:10.1002/hep.26602.

July 11, 2013

Patients with chronic hepatitis C treated with pegylated interferon, ribavirin and either telaprevir or boceprevir frequently experienced renal impairment that typically resolved after switching to dual therapy in a recent study.

As part of the noninterventional PAN study — which includes patients with HCV treated with peginterferon alfa-2a and ribavirin with or without telaprevir or boceprevir — researchers evaluated the estimated glomerular filtration rate (eGFR) of 895 patients with HCV genotype 1 who received at least 12 weeks of therapy and 591 who received 24 weeks or more. Five hundred seventy-five telaprevir patients, 211 taking boceprevir and 109 on dual therapy were in the 12-week group.The 24-week arm had 398 patients on telaprevir, 113 on boceprevir and 80 on dual therapy.

The 12-week analysis measured the impact of treatment on eGFR; the 24-week review determined whether this effect could be reversed after discontinuing telaprevir or boceprevir.

All participants had an eGFR above 60 mL/min at baseline. In the 12-week cohort, 5.5% of patients experienced an eGFR decrease to below 60 mL/min, which was more common among telaprevir (6.6%) and boceprevir (4.7%) recipients than those who received peginterferon/ribavirin alone (0.9%) (P<.05). Multivariate analysis indicated associations between this decrease and advanced age (P<.001), high baseline creatinine levels (P<.001), receipt of telaprevir or boceprevir (P<.01) and arterial hypertension (P<.05).

In the 24-week analysis, 8.3% of telaprevir and 3.5% of boceprevir recipients experienced eGFR decreases to below 60 mL/min after 12 weeks, compared with 1.3% of dual therapy recipients (P<.05). After telaprevir discontinuation at 12 weeks, eGFR below 60 mL/min was observed in 1.3% of those who had received telaprevir, compared with 4.4% of boceprevir recipients and 1.3% of dual therapy recipients (P<.05 for boceprevir vs. dual therapy).

“Renal impairment has not been an issue with dual therapy [interferon and ribavirin],” researcher Stefan Mauss, MD, Center for HIV and Hepatogastroenterology in Dusseldorf, Germany, told Healio.com. “[However,] with the current triple therapy, it has to be added to the adverse event list. Include creatinine in your checklist, and keep an eye in particular on patients with additional risk factors for renal impairment, [such as] older age, arterial hypertension [or] diabetes mellitus.”

Disclosure: See the study for a full list of relevant disclosures.

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