HCV Treatment Administered by Non-Specialists Safe, Effective
Researchers found that 86% of patients achieved a sustained virologic response, with no major safety concerns.
HealthDay News — Non-specialists, including primary care providers (PCPs) and nurse practitioners (NPs), safely and effectively administer direct-acting antiviral therapy for hepatitis C virus (HCV) to patients seen in federally qualified health centers (FQHCs), according to a study published in the Annals of Internal Medicine.
Sarah Kattakuzhy, MD, from the University of Maryland in Baltimore, and colleagues assigned 600 patients (seen at 13 urban FQHCs) 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. Patients received treatment with ledipasvir-sofosbuvir according to U.S. Food and Drug Administration labeling requirements.
The researchers found that 86% of patients achieved a sustained virologic response (SVR), with no major safety concerns. Response rates were similar across the provider types: NPs, 89.3%; PCPs, 86.9%; and specialists, 83.8%. Non-SVR was primarily caused by patient loss to follow-up.
"NPs 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," the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Gilead, which manufactures ledipasvir-sofosbuvir and provided funding for the study.
- Kattakuzhy S, Gross C, Emmanuel B, et al. Expansion of treatment for hepatitis C virus infection by task shifting to community-based nonspecialist providers: a nonrandomized clinical trial [published online August 8, 2017]. Ann Intern Med. doi: 10.7326/M17-0118