Quadruple anti-HCV regimen highly effective in HCV/HIV coinfected individuals

Last Updated: 2015-06-05

By Will Boggs MD

NEW YORK (Reuters Health) - A four-drug anti-HCV regimen provides sustained virological responses (SVR) in most individuals coinfected with HCV and HIV, researchers from France report.

"It is possible to cure nearly all these difficult-to-treat patients with such a combination, which could be of interest as a second-line or salvage approach," Dr. Lionel Piroth from Université de Bourgogne in Dijon told Reuters Health by email.

Previous studies have suggested the superiority of quadruple therapy over dual therapy in HCV monoinfected patients, but few direct anti-HCV agents have been studied in these patients.

Dr. Piroth and colleagues in the ANRS HC30 QUADRIH study group undertook a pilot study to assess the efficacy and safety of quadruple therapy with asunaprevir, daclatasvir, pegylated interferon, and ribavirin in 75 HCV genotype 1 or 4 HIV-coinfected patients who had not responded to previous interferon-ribavirin therapy. Just over a third were cirrhotic (27/75, 36%).

The primary efficacy endpoint, the percentage of patients with undetectable HCV RNA 12 weeks after completing six months of quadruple HCV therapy, was a surprising 96%, the researchers report in Clinical Infectious Diseases, online May 14.

"We speculated when designing the trial on a rate higher than 60%, but not as high as 96%," Dr. Piroth said.

Two of the three patients with detectable HCV RNA experienced virological breakthrough at weeks 12 and 16, and the third patient died at week 24 with undetectable HCV RNA.

Most patients experienced at least one adverse event during therapy, but only four patients - one noncirrhotic patient who developed metastatic lung cancer and three cirrhotic patients who developed pyelonephritis, spondylitis followed by reversible renal failure, and lung abscess - had to stop HCV quadruple therapy prematurely.

"There are other all oral therapeutic solutions which will also likely allow reaching high SVR rate -- so the length of therapy (six months) and the need to use interferon (especially for HCV genotype 1a) preclude its wide use in such a population, despite the impressive SVR rate," Dr. Piroth concluded.

The study was supported by the French National Agency for HIV/AIDS and Viral Hepatitis Research. Bristol-Myers Squibb provided asunaprevir and daclatasvir as well as financial and technical support for the pharmacokinetics substudy.

One of Dr. Piroth's coauthors has received consulting fees from Bristol-Myers Squibb.

SOURCE: http://bit.ly/1RPfYa3

Clin Infect Dis 2015.