Specialists Not Necessary for Direct-Acting Antiviral Treatments

One concern about getting care to everyone infected with the hepatitis C virus has been that there are not enough medical specialists to provide that care.

But in a preliminary study results presented today at the International Liver Conference in Barcelona, researchers said it does not take a specialist to administer that care.

In fact, in a population of mostly middle-aged black men who used two federally qualified health centers in Washington, DC., patients who saw nurse practitioners were the mostly likely to complete treatment.

Discussing the preliminary results of the trial known as ASCEND this morning at a news conference, Sarah Kattachuzy, MD, of the Institute of Human Virology at the University of Maryland said the common belief is that “despite HCV advances there have been concerns about the care continuum,“ specifically that there are not enough infectious disease or hepatology specialists to treat all patients who could benefit from direct-acting antivirals.

That's not so, Kattachuzy said, because it doesn't take a specialist to treat patients with DAAs.

Her team enrolled 600 Medicaid patients with HCV in an urban, medically underserved neighborhood. All began treatment from either a specialist, a primary care provider, or a nurse practitioner. Some were co-infected with HIV.

The results presented today were based on 409 of those patients. The study is ongoing.

All practitioners in the study had received three hours of training in administering DAAs, she said.

Patients got ledipasvir and sofosbuvir. The primary outcome was having their HCV viral load drop below a level that could be quantified at 12 weeks.

All patients who completed treatment achieved that sustained viral response.

Attendance tended to drop off as the study continued. “Patients felt better so some stopped coming,” Kattachuzy said.

The patients who saw nurse practitioners had the highest rate of attendance with 81.5% completing treatment, compared to 76.8% for those who saw primary care providers, and 63.8% of those who saw specialists.

“HCV infection is a sensitive personal thing,” Kattachuzy said, discussing the study in an interview, and they may well feel a bond with the nurses that they do not readily feel with specialists. "The patient-provider relationship is important” she added and when patients feel comfortable talking to that provider they are more likely to keep coming back.

There were 18 patients who did not complete the study, most because they simply stopped coming to appointments. Some had adverse events unrelated to treatment and there were three deaths, also unrelated to treatment.

“The ASCEND model demonstrates that HCV treatment administered independently by non-specialist providers is safe and equally effective to that observed with experienced specialists, inclusive of challenging subpopulations of the epidemic, and within the largest black cohort described to date,” the team concluded in their report.

If scaled up, the approach of using non-specialists could “significantly expand the scale of HCV therapy and bridge existing gaps in the hepatitis C care cascade.”