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Primary care professionals can “substantially expand” HCV treatment in the community, according to new research.
The majority of patients infected with hepatitis C virus (HCV) can be safely, effectively managed in a primary care setting, according to a new study.
Direct-acting antiviral (DAA) therapy for HCV infection has resulted in high rates of disease cure, however, not enough specialists currently are available to provide care, stated researchers led by Sarah Kattakuzhy, MD, assistant professor with the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore, Maryland.
“We found that HCV treatment can be decentralized to facilitate greater therapeutic capacity for the many patients who remain untreated,” Kattakuzhy told Medical Economics.
The researchers published their results August 8, 2017 in the Annals of Internal Medicine.
Kattakuzhy and her colleagues conducted a nonrandomized, open-label clinical trial at 13 urban, federally qualified health centers in the District of Columbia to determine the efficacy of HCV treatment independently provided by primary care physicians, nurse practitioners (NPs) or specialists using DAA therapy.
The 600 patients were predominantly black and treatment naïve; 20% had cirrhosis. About two-thirds of them had HCV genotype 1a infection.
The trial, known as ASCEND (A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia), is the first study to prospectively compare outcomes for HCV treatment with DAAs provided by non-specialists with specialists in a real-world setting that serves mostly urban patients.
The patients were assigned to receive treatment from one of five NPs, five PCPs, or six specialists. All providers underwent an identical 3-hour training session based on guidelines. Patients received treatment with ledipasvir-sofosbuvir, which was provided on site.
The results show 516 patients achieved a sustained virologic response (SVR), a response rate of 86%, with no major safety signals, she said. Response rates were consistent across provider types: nurse practitioners (89.3%), primary care physicians (86.9%) and specialists (83.8%).
Results were similar after adjustments for age, sex, race, HIV and cirrhosis. Also, patients tolerated the therapy well, Kattakuzhy said, with 98% of adverse events either grade 1 or 2.
In this real-world cohort of patients, “HCV treatment administered by non-specialist providers was as safe and effective as that provided by specialists,” she said. Primary care physicians and nurse practitioners 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 researchers stated. “The ASCEND investigation suggests that such insurance-based 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.”
Limitations of the trial include the nonrandomized patient distribution, and possible referral bias. The drug combination had limited dosing variation and few drug–drug interactions, and therefore the results may not generalize to medications with more complex dosing, she said.
Kattakuzhy cautioned that primary care physicians need to consider important drug–drug interactions and recognize when a patient has more advanced liver disease prior to treatment.