December 1, 2016
Sustained virologic response 12 weeks after ledipasvir/sofosbuvir (LDV/SOF, Harvoni) treatment ended (SVR12) proved nearly identical in patients treated by hepatitis specialists, by primary care providers (PCPs) or by nurse practitioners (NP) in a nonrandomized trial in Washington, D.C. SVR12s were also similar with the three types of providers among patients with compensated cirrhosis. But patient visit adherence was better with NPs than with specialists or PCPs.
Direct-acting antivirals (DAAs) are transforming care of HCV infection, but DAA use remains limited because hepatitis specialists still manage most patients taking DAAs. University of Maryland researchers conducted this study to assess the effectiveness of task shifting DAA therapy to nonspecialists.
The study involved 600 HCV patients at two Washington, D.C., clinics assigned to LDV/SOF therapy with a specialist (infectious disease or hepatology), a PCP (family or internal medicine), or a licensed NP. The six specialists, five PCPs and five NPs, all received the same three-hour training course. Of the 600 patients, 69% were men, 96% were black and 23% were coinfected with HIV; 20% had cirrhosis, 82% had never received HCV therapy and 90% received the 12-week course of LDV/SOF. Treatment took place from May through November 2015.
The 121 patients with compensated cirrhosis were older than the 479 without cirrhosis (mean 60.4 versus 58.3 years, P = .003) and included a higher proportion of men (78% versus 67%, P = .03), a higher proportion with HIV (31% versus 21%, P = .03) and a lower proportion of treatment-naive people (74% versus 84%, P = .01). Similar proportions of people with and without cirrhosis were treated by the three types of providers.
An intention-to-treat analysis showed no significant difference in SVR12 in patients treated by specialists (83.0%), PCPs (86.3%) or NPs (89.4%) (P = .19). SVR12s were higher and similar across provider types in a per-protocol analysis: specialists (92.3%), PCPs (94.5%) and NPs (95.0%) (P = .49). Per-protocol analysis limited to cirrhotic patients also found similar SVR12s with the three types of providers: specialists (92.3%), PCPs (92.6%) and NPs (86.7%) (P = .69). An overall comparison of cirrhotic and noncirrhotic patients found little difference in SVR12: cirrhotic (90.8%) and noncirrhotic (94.3%) (P = .18).
Treatment visit adherence (calculated as a composite percentage of visits made every four weeks while on treatment) was similar in cirrhotic and noncirrhotic patients (63% and 62%, P = .70) but significantly higher in patients of NPs (74.5%) than in patients of PCPs (56%) or specialists (60.6%) (P = .04). Prescription pick-up adherence was similar in cirrhotic and noncirrhotic patients (89% and 86%, P = .50).
The researchers concluded that DAA therapy for patients with and without compensated cirrhosis can be assumed by NPs and PCPs. They proposed that task shifting in this way "could expand the scale of HCV therapy and close gaps in the HCV treatment cascade using non-specialist providers."
Mark Mascolini writes about HIV and hepatitis virus infection.
Copyright © 2016 Remedy Health Media, LLC. All rights reserved.
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