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Mavyret safe, efficacious for HCV after liver, kidney transplantation
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Mavyret was safe and efficacious for patients with chronic hepatitis C who underwent liver or kidney transplantation, according to a recently published study.
“The study design and research were based upon the larger Mavyret registrational program, in non-transplant patients,” Nancy S. Reau, MD, from Rush University Medical Center and a member of the American Liver Foundation’s National Medical Advisory Committee, told Healio Gastroenterology and Liver Disease. “The efficacy and safety data from those studies informed the study design in a population that had limited treatment options at the time of study conception.”
According to Reau, kidney transplant patients were included due to the medical need for treatment options for those with renal disease, evolving data for the use of direct-acting antivirals in the renal transplant space, and the safety profile of Mavyret (glecaprevir/pibrentasvir, AbbVie) in those with underlying renal disease.
The study comprised 100 patients with HCV from U.S. and international centers who received glecaprevir/pibrentasvir for 12 weeks. Eighty patients had undergone liver transplantation and 20 had received kidney transplant. Of the 44% who were treatment-experienced, most received an interferon-based regimen before their transplant surgery.
One patient discontinued early due to a cerebrovascular accident unrelated to treatment but achieved sustained virologic response.
The SVR rate for intention-to-treat was 98% (95% CI, 95.3-100) with two patients designated as nonresponders due to relapse at 4 weeks and nonvirologic failure. After investigators excluded nonresponders, the SVR rate was 99% (95% CI, 97-100).
Most adverse events were mild (56%). Of the eight patients who experienced serious adverse events, the researchers considered two related to treatment including a case of sinusitis and abnormal hepatic function.
“The efficacy and safety were comparable to the nontransplant populations confirming that groups previously felt to have limited options are excellent candidates for DAA therapy,” Reau said.
Reau noted that these study results expand on the safety and efficacy of DAAs in the posttransplant setting and provide data on the use of glecaprevir/pibrentasvir for the posttransplant population.
“Rules regarding contraindications to HCV therapy are being broken,” she said. “Prior groups that were felt to be high risk for treatment, such as those with organ transplantation, can effectively be cured with safety and efficacy comparable to traditionally easy to treat patients. This is the biggest take away to an audience managing patients with HCV. Still we cannot be cavalier with complex patients. They still require close monitoring and careful assessment for adverse events and drug-drug interactions.”
Disclosures: AbbVie sponsored the study, contributed to its design and participated in the collection, analysis and interpretation of the data and in the writing and approval of the publication. Reau reports she advises and receives grants from AbbVie and advises Merck and Gilead. Please see the full study for the other authors’ relevant financial disclosures.