Direct-acting Antivirals Help Non-specialists Effectively Manage Hepatitis C Virus
An estimated 2.7 million Americans have hepatitis C, too many for specialists to be the sole provider of anti-HCV therapy.
New, direct-acting antivirals (DAAs) will allow primary care providers (PCPs) and nurse practitioners (NPs) to safely and effectively manage hepatitis C virus (HCV) in patients, according to a study.
A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection with HIV in the District of Columbia (ASCEND) was the first study to compare the outcomes of HCV treatment by specialists vs. nonspecialists in a real-world setting.
"Because of these requirements, most PCPs and NPs in the United States currently are not permitted to provide independent HCV treatment,” Sarah Kattakuzhy, MD, from the University of Maryland School of Medicine, Baltimore (pictured), and colleagues wrote. “The ASCEND investigation suggests that such provider restrictions are not supported by evidence and stand as unnecessary hurdles in the HCV care continuum.”
Previous studies have suggested that nonspecialists treating uncomplicated HCV could increase the access to HCV treatment without having an effect on cure rates, but limited supporting evidence exists.
Currently, a referral for specialist care is required to receive direct-acting antiviral treatment. It is estimated that 2.7 million Americans have HCV, too many for specialists to be the sole provider of anti-HCV therapy.
“Reversal of such policies might allow rapid escalation of safe, effective therapy for HCV infection and improve the care of patients living with this potentially fatal disease," the authors wrote.
The evaluation of the safety and efficacy of nonspecialist deliverance of direct-acting antivirals was done with a nonrandomized, open-label trial that included 600 patients in 13 urban community health centers for 12 weeks.
150 patients (25%) were assigned to receive treatment from NPs, 160 (27%) from PCPs, and 290 (48%) from specialists. All 3 provider groups received a 3-hour, guideline-based training session for providing ledipasvir-sofosbuvir to HCV patients.
The results showed that 516 patients achieved sustained viral response (86.0%) and that no matter what provider was seen, similar rates were achieved. Those treated by NPs had an 89.3% response rate, PCPs an 86.9% rate, and specialists an 83.8% rate.
Additionally, patient toleration went over well, with only 3 patients discontinuing treatment due to severe headache, rash, and severe gastroesophageal reflux disease. 98% of events that occurred were determined grade 1 or 2.
"[The] results support decentralization of HCV treatment to facilitate greater therapeutic capacity for the many patients who remain untreated," Kattakuzhy and colleagues wrote.
The ASCEND study was originally published in the Annals of Internal Medicine.