Gilead joins ongoing NASH, HBV observational study initiative

TARGET PharmaSolutions has partnered with Gilead Sciences for the TARGET-NASH observational study of nonalcoholic fatty liver disease and the TARGET-HBV observational study of hepatitis B, according to a press release.

“TARGET-NASH is critical for the scientific and regulatory community as we prepare for the plethora of new agents for the treatment of NASH,” Arun Sanyal, MD, from the Virginia Commonwealth University and co-chair of the studies’ academic steering committee, said in the release.

“In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world across multiple populations,” he continued. “In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included or underrepresented in phase 3 clinical trials.”

The researchers have enrolled more than 4,250 patients with nonalcoholic fatty liver disease or NASH in the TARGET-NASH study and will continue to enroll up to 15,000 over the coming years.

The TARGET-HBV study will enroll up to 5,000 patients with HBV from a diverse network of sites.

According to the release, Gilead is the sixth partner to join the TARGET-NASH initiative, following Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Intercept and Novartis.

Reference: www.targetpharmasolutions.com