NIH Study to Evaluate Hepatitis C Treatment

The National Institutes of Health (NIH) and the city of Washington, D.C. have partnered to launch a clinical trial that will evaluate the role of primary care physicians as well as other healthcare providers in using a new antiviral therapy to treat hepatitis C virus (HCV) infection.

The ASCEND study—being conducted as part of the D.C. Partnership for HIV/AIDS Progress program, geared toward reducing the burden of HIV/AIDS and associated diseases—will include 600 adult residents of the D.C. area who are infected with HCV alone or co-infected with HCV and HIV. Co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), with additional support from the NIH Office of AIDS Research, the trial will examine whether primary care practitioners, as well as other providers such as nurse practitioners and physician assistants, are as effective as specialist physicians in treating HCV, and will also examine the long-term effects of the treatment.
______________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Study: Many Hep C Patients Do Not Complete Treatment
Oral Drug Combo Shows Promise for Hep C Cure
______________________________________________________________________________________________________________________________________________________________

Participants will be monitored over a 10-year period for short-term and long-term treatment outcomes, including viral response to a new, once-daily antiviral drug for treatment of hepatitis C infection that combines ledipasvir and sofosbuvir (trade name Harvoni), which could provide more effective, shorter-duration, curative treatments.

Researchers also intend to determine whether the type of provider administering the treatment has an impact on outcomes, in addition to assessing the safety of the drug, how well it is tolerated, and whether there are differences in outcomes for those infected with both HCV and HIV, compared to those with HCV alone. The investigators anticipate the study will be completed in 2025.

“In most cases, primary care physicians have had little experience treating hepatitis C, says Henry Masur, MD, chief of the critical care medicine department at the NIH Clinical Center, and the study’s principal investigator.

“Moreover, some insurance companies require that hepatitis C therapy be administered by specialists rather than primary care providers,” says Masur, noting that “it is not clear, however, that specialists are needed to treat patients as long as their liver disease is in its early stages.”

In this trial, Masur and colleagues plan to look at the success rate for primary care physicians and nurse practitioners who treat hepatitis C outside of a research setting, he says, adding that providers are given 3 hours of instruction and a copy of current treatment guidelines before selecting patients and providing treatment according to the package insert for the drugs and the national guidelines.

“The study will assess whether primary care providers, with a short training session, can attain comparable success to heavily supervised research studies,” says Masur. “This study may provide evidence for insurers about whether subspecialist care is necessary for a good outcome for therapy for patients with early and mid-stage fibrosis, recognizing that patients with late disease will need care by hepatologists.” 

—Mark McGraw