BOSTON — In the ASCEND clinical trial, researchers found that hepatitis C virus infection treatment administered to a patient by a primary care physician or nurse practitioner is safe and effective, according to a Late Breaker presented at CROI 2016.
“For the first time, we demonstrate that HCV treatment administered independently by [primary care physicians] and [nurse practitioners] is safe and effective [and] inclusive of challenging subpopulations of the epidemic,” Sarah M. Kattakuzhy, MD, assistant professor of medicine, Institute of Human Virology at the University of Maryland, and colleagues wrote.
Six hundred patients with chronic HCV seen at various community health centers in Washington, D.C. were nonrandomly assigned to a treatment regimen of Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) from May to November 2015 administered by an infectious disease or hepatology specialist (n = 94), primary care physician (PCP; n = 38) or nurse practitioner (NP; n =49). A majority of the patients were black (96%) and had HCV genotype 1a (72%). Also among the cohort were patients with HIV/HCV co-infection (24%), Child-Pugh A cirrhosis (20%) or who were treatment-experienced (18%).
The primary objective of the study was to determine unquantifiable HCV RNA viral load 12 weeks after completion of therapy. Follow-up is ongoing, according to the abstract.
Analyses showed 95.9% of patients administered treatment by an NP (n = 47), 94.7% given treatment by a PCP (n = 36) and 91.5% of patients given treatment by specialists (n = 86) achieved SVR12 post-treatment. Of 419 patients who completed 12 weeks of treatment, composite adherence was associated with provider type: 50% in NPs, 41% in PCPs and 19% in specialists (P < .001). HIV status did not impact SVR12 or SVR12 by provider type.
There was no significant difference between sustained virologic response 12 weeks post-treatment based on per protocol analysis and provider type (P = .67).
Overall, 14 patients discontinued treatment early, some due to adverse events (n = 4) and mortality unrelated to study participation (n = 1). Of these, 169 achieved SVR12 (93.4% in the per protocol analysis, 86.7% in an intention-to-treat analysis).
Twelve patients experienced virologic failure, of which one had virologic breakthrough and 11 relapsed.
The researchers concluded: “Community based nonspecialist providers could significantly expand the scale of HCV therapy.” – by Melinda Stevens
Kattakuzhy SM, et al. Abstract #538LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.
Disclosure: Kattakuzhy reports her institution received a grant from Gilead Sciences.