Mavyret safe, effective for HCV with chronic kidney disease

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.

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.