Treatment for hepatitis C virus (HCV) infection provided by nurse practitioners (NPs) and primary care physicians (PCPs) appeared to be as safe and effective as treatment provided by subspecialists, according to a new study.
Researchers performed a nonrandomized open-label clinical trial to compare the efficacy of HCV treatment with direct-acting antivirals (DAAs) provided by NPs, PCPs, or subspecialists. The trial began in 2015 and was performed at 13 urban federally qualified health centers in the District of Columbia. Patients were assigned to receive treatment with ledipasvir-sofosbuvir from one of five NPs, five PCPs, or six subspecialists, all of whom had participated in an identical three-hour guideline-based training session. PCPs were physicians board-certified in internal medicine or family medicine, while subspecialists were internists specializing in infectious diseases or gastroenterology/hepatology.
Patients had treatment visits once per month with their clinician, and ledipasvir-sofosbuvir was prescribed in four-week increments. The primary outcome was sustained virologic response, defined as undetectable HCV RNA viral load 12 weeks after treatment was completed. Adverse events were determined by questioning and examinations. The study was funded by the National Institutes of Health and Gilead Sciences. Results were published Aug. 8 by Annals of Internal Medicine.
A referred sample of 600 patients was included in the study. Overall, 96% were black, 69% were men, 82% were treatment-naïve, 20% had cirrhosis, and 72% were infected with HCV genotype 1a. One hundred fifty patients (25%) were assigned to an NP, 160 were assigned to a PCP (27%), and 290 (48%) were assigned to a subspecialist. Five hundred sixteen patients had sustained virologic response (response rate, 86% [95% CI, 83.0% to 88.7%]), and rates were consistent for all three types of clinician (89.3% [95% CI, 83.3% to 93.8%] for NPs, 86.9% [95% CI, 80.6% to 91.7%] for PCPs, and 83.8% [95% CI, 79.0% to 87.8%] for subspecialists). Eighty-four patients did not have sustained virologic response; the most common reason was loss to follow-up (54%), followed by viral relapse (42%) and death (4%). Adverse events occurred in 98 patients and were considered low severity, mainly fatigue and headache, in 96 (98%).
The researchers noted that their study was not randomized and may have involved referral bias, among other limitations. However, they concluded that HCV treatment by NPs and PCPs was as safe and effective as HCV treatment provided by subspecialists. The authors pointed out that study patients were given the study drug at the treating facility, avoiding the prior authorization process that most insurance plans require and that often restricts prescription of DAA therapy to certain types of clinicians. This study “suggests that such provider restrictions are not supported by evidence and stand as unnecessary hurdles in the HCV care continuum,” the authors wrote. “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.”