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C-EDGE: Grazoprevir/elbasvir benefits HIV/HCV coinfected patients

Issue: December 2015

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SAN FRANCISCO — A fixed-dose combination of grazoprevir and elbasvir produced high SVR24 rates in patients coinfected with HIV, according to findings presented at The Liver Meeting 2015.

“Regardless of disease stage, this regimen seemed to work well,” Jürgen K. Rockstroh, MD, of Bonn University in Bonn, Germany, said in his presentation. “There was no difference with regard to HIV regimen.”

Rockstroh presented 218 patients treated with 100 mg grazoprevir (Merck) and 50 mg elbasvir (Merck) for 12 weeks in the open-label study. All patients received HIV therapies, with stable CD4 cell counts and undetectable HIV RNA. The study was conducted in Australia, Europe and the U.S. and included patients with genotype 1, 4 and 6 infection with or without cirrhosis. “The median age was slightly lower than for most of the monoinfection trials, and 17% of our cohort was black or African American,” he said.

Twenty four-week follow-up data are presented.

There were 144 patients with genotype 1a HCV, 44 with 1b, 28 with genotype 4 and two patients with genotype 6 disease.

The overall SVR24 rate was 93.1% in the full analysis set. The SVR rate was 93.1% among patients with genotypes 1a and 1b disease, and 92.9% for those with genotype 4. In the modified full analysis set, which excluded patients with reinfections or those lost to follow-up, the overall SVR rate was 97.6%.

Patients with baseline NS5A resistance-associated variants (RAVs) reached an SVR24 rate of 94%. The rate was 98% for those without baseline NS5A RAVs.

“There is no major impact of NS5A RAVs for this particular analysis,” Rockstroh said.

There were five relapses, all among non-cirrhotic patients. Two patients with genotype 1 disease were reinfected with a genotype 3 infection. 

Eight serious adverse events were reported, but no patient discontinued due to adverse events. There were no deaths recorded.

Regarding HIV parameters, two patients experienced transient HIV viremia during treatment. However, they ultimately reached undetectable HIV RNA with adjustment to therapy.

“We observed comparable response rates to HCV monoinfected populations receiving this compound,” Rockstroh said. “Elbasvir and grazoprevir represents another highly effective treatment option for patients with coinfection.” – by Rob Volansky

Reference:

Rockstroh JK, et al. Abstract 210. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Rockstroh reports financial relationships with Abbott, AbbVie, Bionor, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Roche, Tibotec, Tobira and  ViiV. Please see the full study for a list of all other authors’ relevant financial disclosures.