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PCPs safely, effectively administer HCV treatment

Nonspecialists such as primary care physicians and nurse practitioners can administer direct-acting antiviral therapy for hepatitis C virus as safely and effectively as specialists, which expands treatment access for challenging populations with HCV, according to recent findings.

“In the [direct-acting antiviral] era, complete task shifting of HCV therapy to general practitioners may be the ideal strategy for patients with uncomplicated infection,” Sarah Kattakuzhy, MD, assistant professor of medicine at University of Maryland School of Medicine, and colleagues wrote in Annals of Internal Medicine. “Yet, information of the success of nonspecialists practicing independent of specialist supervision is limited.”

Researchers compared the efficacy of HCV treatment managed by PCPs, nurse practitioners, and specialist physicians using direct-acting antiviral therapy. In this prospective, observational study, the investigators measured sustained virologic response (SVR) in 600 patients with chronic HCV infection at 13 federally qualified health centers in Washington, D.C. They assigned participants to receive treatment with Harvoni (ledipasvir-sofosbuvir, Gilead Sciences) from one of 16 providers (5 PCPs, 5 nurse practitioners and 6 specialists) who completed identical training sessions based on hepatitis treatment guidelines recommended by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

Of 600 participants, 150 received treatment from nurse practitioners, 160 from PCPs and 290 from specialists. The results showed that 516 patients achieved SVR, a response rate of 86% (95% CI, 83-88.7) without any major safety signals. The response rate was consistent across all provider types: 86.9% (95% CI, 80.6-91.7) for PCPs; 89.3% (95% CI, 83.3-93.8) for nurse practitioners and 83.8% for specialists (95% CI, 79-87.8).

After adjustment for age, sex, race, HIV status and cirrhosis status, the overall SVR rate was 87.1%. When separated by provider type, the SVR rates were 87.6% (95% CI, 62-96.8) for patients treated by PCPs, 90.4% (95% CI, 59-98.4) for those treated by nurse practitioners, and 84.8% (95% CI, 70.2%-93%) for those treated by specialists. The major cause of non-SVR was patient loss to follow-up (7.5% of patients). These findings show that task shifting of HCV treatment to nonspecialist providers was safe and effective, according to researchers.

“This investigation differs from real-life practice in that all providers dispensed medication directly to patients at the treating facility, avoiding the rigorous process of prior authorization — including restrictions regarding provider type — currently required by public and private insurance plans and managed by care organizations in most states,” Kattakuzhy and colleagues wrote. “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.” – by Savannah Demko

Disclosures: Kattakuzhy reports grants and nonfinancial support from Gilead Sciences. Please see the full study for a complete list of all other authors’ relevant financial disclosures.