Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial

Abstract

Background: Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of disease cure; however, not enough specialists currently are available to provide care.

Objective: To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy.

Design: Nonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038).

Setting: 13 urban, federally qualified health centers (FQHCs) in the District of Columbia.

Patients: A referred sample of 600 patients, of whom 96% were black, 69% were male, 82% were treatment naive, and 20% had cirrhosis. Seventy-two percent of the patients had HCV genotype 1a infection. The baseline characteristics of patients seen by each provider type were similar.

Intervention: Patients were assigned in a nonrandomized but specified manner to receive treatment from 1 of 5 NPs, 5 PCPs, or 6 specialists. All providers underwent an identical 3-hour training session based on guidelines. Patients received treatment with ledipasvir-sofosbuvir, which was provided on site, according to U.S. Food and Drug Administration labeling requirements.

Measurements: Sustained virologic response (SVR).

Results: 516 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Response rates were consistent across the 3 provider types: NPs, 89.3% (CI, 83.3% to 93.8%); PCPs, 86.9% (CI, 80.6% to 91.7%); and specialists, 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.

Limitation: Nonrandomized patient distribution; possible referral bias.

Conclusion: In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection.

Primary funding source: National Institutes of Health and Gilead Sciences.

Figure 1

Patient disposition. AE = adverse event; LDV–SOF = ledipasvir–sofosbuvir; LTFU = lost to follow-up; NP = nurse practitioner; PCP = primary care physician; SVR = sustained virologic response. *Patients who were LTFU or died were considered to have treatment failure in the final analysis.

Figure 2

SVR, by provider. NP = nurse practitioner; PCP = primary care physician; SVR = sustained virologic response.