Glecaprevir/pibrentasvir Treats Hepatitis C in HIV-coinfected Individuals

By Reuters Staff

April 03, 2018

NEW YORK (Reuters Health) - The direct-acting antiviral (DAA) combination glecaprevir/pibrentasvir is effective for treating hepatitis C virus (HCV) infection in individuals coinfected with HIV-1, according to results from the non-randomized, open-label phase 3 EXPEDITION-2 trial.

As many as 3 million of the 80 million individuals infected with HCV worldwide are coinfected with HIV-1. Most guidelines recommend these patients be treated like those with HCV monoinfection, with careful monitoring for drug-drug interactions with antiretroviral therapy (ART).

Glecaprevir/pibrentasvir, marketed by AbbVie, Inc. as Mavyret in the U.S., was approved last year to treat all major genotypes of chronic hepatitis C.

Dr. Juergen K. Rockstroh from Universitaetsklinikum Bonn in Germany and colleagues tested eight weeks of treatment with once-daily oral glecaprevir/pibrentasvir in patients with HCV genotype 1-6 infection without cirrhosis and coinfected with HIV-1. They also tested 12 weeks of treatment in coinfected patients with compensated cirrhosis.

Of the 153 patients treated with glecaprevir/pibrentasvir, 150 (98%) achieved sustained virologic responses 12 weeks after the last day of treatment (SVR12), which was noninferior to the historical standard of care, the researchers report in Clinical Infectious Diseases, online March 16.

Most patients (95%) had undetectable HCV RNA by week 4 of treatment.

Excluding one patient missing SVR12 data and one who prematurely discontinued treatment, the SVR12 rate was 100% (136/136) in patients without cirrhosis treated for eight weeks and 93% (14/15) in patients with cirrhosis treated for 12 weeks. There were no relapses.

Most adverse events were mild and included fatigue and nausea. Four patients experienced serious adverse events deemed unrelated to study drug.

All patients taking ART maintained HIV-1 suppression during the study.

“These results support the indication of glecaprevir/pibrentasvir as the first 8-week pangenotypic treatment option for HCV/HIV-1 coinfected patients without cirrhosis,” the researchers conclude.

Dr. Rockstroh and Roger Trinh from AbbVie, in Chicago, did not respond to a request for comments.

AbbVie funded the study and had various financial ties to most of the authors.


Clin Infect Dis 2018.