Gane E, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1704053.

October 11, 2017
1 min read

Mavyret safe, effective for HCV with chronic kidney disease


Gane E, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1704053.

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Treatment with Mavyret for 12 weeks resulted in high rates of sustained virologic response among patients with hepatitis C and stage 4 or 5 chronic kidney disease, according to a recently published study.

“Renal insufficiency is an important extrahepatic manifestation of HCV infection. The development of HCV-related cirrhosis and consequent portal hypertension can complicate potential kidney transplantation for these patients,” Edward Gane, MD, from the Auckland City Hospital, New Zealand, and colleagues wrote. “Currently, ribavirin-free treatment options for patients with end-stage renal disease and concomitant HCV genotype 1 infection are limited, and no approved interferon-free and ribavirin-free treatment options are available for patients infected with HCV genotype 2, 3, 5, or 6.”

The researchers enrolled 104 patients with HCV genotypes 1 through 6 and stage 4 or 5 chronic kidney disease in the phase 3 EXPEDITION-4 study to receive 12 weeks of Mavyret (glecaprevir/pibrentasvir, AbbVie). Mean patient age was 57 years (range, 28-83 years), 60 patients were treatment-naive, 20 had compensated cirrhosis, 54 had HCV genotype 1, and 90 had stage 5 chronic kidney disease.

At 12 weeks, 102 patients achieved SVR (95% CI, 95-100) with no virologic failures reported in the cohort.

One of the two patients who did not achieve sustained virologic response died after 2 weeks of treatment due to cerebral hemorrhage unrelated to the trial drug. The other patient had a history of gastrointestinal tract telangiectasia and discontinued the trial treatment after 4 weeks due to diarrhea, which researchers considered possibly treatment-related.

At 24 weeks, 100 patients maintained SVR (95% CI, 95-100). Two patients were lost to follow-up, but had achieved SVR at 12 weeks. None of the patients with NS3 or NS5A polymorphisms experienced virologic failure.

Twenty-one patients reported pruritus, 15 reported fatigue and 12 reported nausea. Of the 25 patients who reported serious adverse events, the researchers did not consider any drug-related. – by Talitha Bennett

Disclosure: The study was funded by AbbVie. Please see the full study for the authors’ relevant financial disclosures.