Primary care providers (PCPs) and nurse practitioners (NPs) can safely and effectively manage care for patients with hepatitis C virus (HCV), using new drugs, according to a study published online August 7 in the Annals of Internal Medicine.
ASCEND (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) is the first study to prospectively compare outcomes for treating HCV with direct-acting antivirals delivered by nonspecialists vs specialists in a real-world setting serving mostly urban, impoverished patients.
“[T]hese results support decentralization of HCV treatment to facilitate greater therapeutic capacity for the many patients who remain untreated,” Sarah Kattakuzhy, MD, from the University of Maryland School of Medicine, Baltimore, and colleagues write.
To evaluate the efficacy and safety of direct-acting antivirals delivered independently by nonspecialists, researchers conducted a nonrandomized open-label trial in 13 urban community health centers in the District of Columbia. The study included 600 patients (96% black, 69% male, 20% with cirrhosis). The researchers nonrandomly assigned patients to receive HCV therapy (ledipasvir-sofosbuvir) from licensed NPs (n = 150; 25%), PCPS (n = 160; 27%) or specialists (n = 290; 48%). All providers received the same 3-hour guideline-based training for providing anti-HCV therapy with ledipasvir-sofosbuvir.
Results showed that 516 patients achieved sustained viral response, for a response rate of 86.0% (95% confidence interval [CI], 83.0% – 88.7%).
Patients had similar sustained viral response rates no matter which provider they saw (NPs, 89.3% [95% CI, 83.3% – 93.8%]; PCPs, 86.9% [95% CI, 80.6% – 91.7%]; specialists, 83.8% [96% CI, 79.0% – 87.8%]).
Results were similar when adjusted for age, sex, race, HIV, and cirrhosis.
Cure rates were slightly lower but consistent with these findings in patients with HIV or cirrhosis, suggesting nonspecialists could effectively provide treatment even in more complex patients.
Patients tolerated therapy well, with 98% of adverse events judged grade 1 or 2. Only three patients discontinued treatment as a result of therapy (severe headache, rash, severe gastroesophageal reflux disease).
Direct-acting antivirals can result in high cure rates for HCV, but currently require referral for specialist care. Approximately 2.7 million Americans have HCV, a number far too high for specialists to provide anti-HCV therapy.
Past studies have suggested that partially shifting the task of treating uncomplicated HCV to nonspecialists may increase access to HCV treatment without affecting cure rates. However, limited evidence exists to support this approach.
The authors noted several limitations, including the study’s nonrandomized design. Also, the drugs used in this study had limited dosing variation and few drug–drug interactions. Results may not generalize to medications with more complex dosing.
Finally, providers dispensed the medication directly at the clinic, thus avoiding prior authorization and other restrictions placed by public and private insurance.
“Because of these requirements, most PCPs and NPs in the United States currently are not permitted to provide independent HCV treatment. The ASCEND investigation suggests that such provider restrictions are not supported by evidence and stand as unnecessary hurdles in the HCV care continuum. 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 concluded.
The study was funded by the National Institutes of Health and Gilead Sciences. One or more authors reports grants, nonfinancial support, and/or stock ownership from one or more of the following: Gilead Sciences, Merck, Pfizer, Johnson & Johnson.