In the Journals

Renal function unaffected in patients with CKD, HCV treated with Zepatier

Zepatier treatment for chronic hepatitis C in patients with stage III chronic kidney disease resulted in almost all patients — including patients with HIV coinfection — achieving sustained virologic response and did not worsen renal function, , according to results of a retrospective study.

“Declining kidney function among patients with already moderately impaired renal disease ... increases the risk of renal-related comorbidities and the associated health care burden,” K. Rajender Reddy, MD, from the University of Pennsylvania, and colleagues wrote. “Treatment options for patients with HCV infection and moderately impaired renal function therefore should combine high rates of virologic cure with a safety profile that does not further impair renal function.”

The researchers conducted a study of patients with stage III chronic kidney disease enrolled in multiple Zepatier (elbasvir/grazoprevir, Merck) phase 2/3 clinical trials. Patients included in the study had chronic HCV infection and received elbasvir 50 mg/grazoprevir 100 mg with or without ribavirin for 8 to 18 weeks. Researchers defined stage III chronic kidney disease as estimated glomerular filtration rate (eGFR) less than 60 to 30 mL/min/1.73 m2 or greater at baseline.

Out of 1,689 patients, the researchers identified 32 for analysis. One patient was treated for 8 weeks, 26 were treated for 12 weeks and five were treated for 16 to 18 weeks. Thirteen patients had HIV, 10 of whom were receiving concomitant Viread (tenofovir, Gilead). Compared with all 1,689 patients with HCV, the proportion of patients with HIV coinfection was higher in the cohort with stage III chronic kidney disease (17% vs. 41%).

Median eGFR at baseline was 56 mL/min/1.73 m2 (range, 45-59), 58 mL/min/1.73 m2 (range, 41-78) at end of treatment and 59 mL/min/1.73 m2 (range, 38-78) at 12 weeks follow-up. Thirty-one patients achieved sustained virologic response.

The 10 patients with HIV coinfection receiving concomitant tenofovir had similar eGFR at baseline (56.5 mL/min/1.73 m2; range, 50-58), end of therapy (57 mL/min/1.73 m2; range, 46-59) and 12 weeks follow-up (58 mL/min/1.73 m2; range, 52-64) compared with the 22 patients who did not receive the concomitant therapy at baseline (56 mL/min/1.73 m2; range, 52-58), end of therapy (58 mL/min/1.73 m2; range, 56-65) and 12 weeks follow-up (60 mL/min/1.73 m2; range, 54-66).

“Data presented here are consistent with the known safety profile of [elbasvir/grazoprevir] in patients with severe renal impairment, and suggest that [elbasvir/grazoprevir] is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR,” the researchers wrote. “While on HCV therapy, 12 of 32 patients showed an improvement in [chronic kidney disease] stage, and thus the question of any potential benefit, along with predictors of improvement in renal function after successful HCV treatment, needs to be explored in a larger cohort.” – by Talitha Bennett

Disclosure : Reddy reports he is an advisor for AbbVie, Bristol-Myers Squibb, Gilead, Merck and Janssen and has received research funding from AbbVie, Bristol-Myers Squibb, Gilead and Merck. Please see the full study for the other researchers’ relevant financial disclosures.

Zepatier treatment for chronic hepatitis C in patients with stage III chronic kidney disease resulted in almost all patients — including patients with HIV coinfection — achieving sustained virologic response and did not worsen renal function, , according to results of a retrospective study.

“Declining kidney function among patients with already moderately impaired renal disease ... increases the risk of renal-related comorbidities and the associated health care burden,” K. Rajender Reddy, MD, from the University of Pennsylvania, and colleagues wrote. “Treatment options for patients with HCV infection and moderately impaired renal function therefore should combine high rates of virologic cure with a safety profile that does not further impair renal function.”

The researchers conducted a study of patients with stage III chronic kidney disease enrolled in multiple Zepatier (elbasvir/grazoprevir, Merck) phase 2/3 clinical trials. Patients included in the study had chronic HCV infection and received elbasvir 50 mg/grazoprevir 100 mg with or without ribavirin for 8 to 18 weeks. Researchers defined stage III chronic kidney disease as estimated glomerular filtration rate (eGFR) less than 60 to 30 mL/min/1.73 m2 or greater at baseline.

Out of 1,689 patients, the researchers identified 32 for analysis. One patient was treated for 8 weeks, 26 were treated for 12 weeks and five were treated for 16 to 18 weeks. Thirteen patients had HIV, 10 of whom were receiving concomitant Viread (tenofovir, Gilead). Compared with all 1,689 patients with HCV, the proportion of patients with HIV coinfection was higher in the cohort with stage III chronic kidney disease (17% vs. 41%).

Median eGFR at baseline was 56 mL/min/1.73 m2 (range, 45-59), 58 mL/min/1.73 m2 (range, 41-78) at end of treatment and 59 mL/min/1.73 m2 (range, 38-78) at 12 weeks follow-up. Thirty-one patients achieved sustained virologic response.

The 10 patients with HIV coinfection receiving concomitant tenofovir had similar eGFR at baseline (56.5 mL/min/1.73 m2; range, 50-58), end of therapy (57 mL/min/1.73 m2; range, 46-59) and 12 weeks follow-up (58 mL/min/1.73 m2; range, 52-64) compared with the 22 patients who did not receive the concomitant therapy at baseline (56 mL/min/1.73 m2; range, 52-58), end of therapy (58 mL/min/1.73 m2; range, 56-65) and 12 weeks follow-up (60 mL/min/1.73 m2; range, 54-66).

“Data presented here are consistent with the known safety profile of [elbasvir/grazoprevir] in patients with severe renal impairment, and suggest that [elbasvir/grazoprevir] is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR,” the researchers wrote. “While on HCV therapy, 12 of 32 patients showed an improvement in [chronic kidney disease] stage, and thus the question of any potential benefit, along with predictors of improvement in renal function after successful HCV treatment, needs to be explored in a larger cohort.” – by Talitha Bennett

Disclosure : Reddy reports he is an advisor for AbbVie, Bristol-Myers Squibb, Gilead, Merck and Janssen and has received research funding from AbbVie, Bristol-Myers Squibb, Gilead and Merck. Please see the full study for the other researchers’ relevant financial disclosures.