Brief

AASLD: AbbVie reports positive 8-week data in HCV

Dive Brief:

  • AbbVie's investigational drug regimen to treat chronic hepatitis C virus (HCV) resulted in nearly all patients having no detectable evidence of the virus in their bloodstream after eight weeks of treatment, the company said Nov. 11 at the American Association for the Study of Liver Diseases (AASLD) annual meeting. 
  • Fully 97.5% of the 700-plus patients – without cirrhosis, new to treatment, and across all major genotypes – who got the once-daily, fixed-dose combination of glecaprevir (ABT-493)/pibrentasvir (ABT-530), dubbed G/P for short, had high SVR rates after eight weeks, AbbVie told The Liver Meeting in Boston. Glecaprevir is being developed through Enanta Pharmaceuticals' collaboration with AbbVie. Having high sustained viral response (SVR) rates at 24 weeks post-treatment is considered a "cure."
  • Across three studies, the rate of virologic failure was 1% and no patients discontinued G/P treatment because of adverse effects, AbbVie said.

Dive Insight:

There are numerous highly effective HCV treatments available now, and a key differentiator in the crowded market could be the introduction of therapies with shorter regimens of six or eight weeks rather than the standard 12 weeks.

"The SVR rates in these studies are an important step toward providing an 8-week treatment option to HCV-infected patients without cirrhosis who are new to treatment," said Jay Luly, Enanta's president and CEO. "We look forward to AbbVie’s regulatory approval filings planned in the U.S. by the end of this year and in Europe and Japan in early 2017."

Jefferies equity analyst Brian Abrahams said the most notable aspect of the first full day of the AASLD annual meeting was the maturity of the HCV space. He noted that "multiple cocktails are now looking competitive," and noted that there were "no major stumbles or surprises" for HCV competitors. He also cited the "emerging but still very early" non-alcoholic steatohepatitis (NASH) space, for which several companies discussed early data, as an area to follow.

Among them was Enanta, which presented additional preclinical data, including data indicating that its Farnesoid X Receptor (FXR) agonist, EDP-305, reduced fibrosis progression in bile-duct ligated rats. EDP-305, being developed for the treatment of NASH, is now in Phase I clinical development.

Also at the meeting, Merck announced findings for its investigational triple-combination chronic hepatits C therapy, showing high rates of SVR in people with genotypes, 1, 2 or 3 infection.

"Across the chronic hepatitis C treatment landscape, incredible progress has been made in a remarkably short amount of time, but there remains a need for more options, particularly for patients who do not achieve sustained virologic response with treatment regimens available today," said Eliav Barr, SVP of global clinical development for infectious diseases and vaccines at Merck Research Laboratories.

Filed Under: Drug Discovery Clinical Trials Corporate News