Patients with HCV infection achieved the same rates of sustained virologic response regardless of whether they were treated by a specialist or non-specialist provider.
Patients with hepatitis C virus (HCV) infection achieved the same rates of sustained virologic response (SVR) regardless of whether they were treated by a specialist or non-specialist, in the first prospective trial comparing HCV treatment outcomes by provider in a real-world cohort.
Sarah Kattakuzhy, MD, Clinical and Administrative Director of the DC PFAP Hepatitis Clinical Research Program, and Assistant Professor of Institute of Human Virology in the Division of Infectious Diseases at the University of Maryland, and lead author of the study explained how their findings could support an expansion of HCV treatment.
"Patients are often reticent to see additional providers, and specialist-based treatment may incur additional cost, travel, and/or wait time, particularly in medically underserved areas," Kattakuzhy told MD Magazine. "Non-specialist based HCV therapy could help close existing gaps in the HCV care cascade, bringing more patients to treatment and cure."
Kattakuzhy and colleagues cited a study that found that of 43% of patients with HCV who were aware of their diagnosis and established with a healthcare provider, only 16% began treatment. They point out that the approximate 20,000 gastroenterology-hepatology and infectious disease physicians in the US are insufficient to meet the treatment demands of the estimated 2.7 million Americans living with HCV infection.
The researchers suggest, however, that the high SVR rates achieved with well-tolerated, straight forward regimens of direct-acting antivirals (DAAs) presents the possibility of expanding the number of treatment providers and attaining widespread cure.
The phase 4 ASCEND trial was conducted to assess outcomes in patients with HCV infection from treatment managed independently by 3 types of community-based providers: nurse practitioners (5), primary care (5) and specialist physicians (5 infectious disease and 1 hepatologist). All practitioners completed a uniform 3-hour training course before the study.
Six hundred patients with chronic HCV (72% with genotype 1a), including 23% with HIV and 20% with cirrhosis, were recruited from 13 participating federally qualified health centers (FQHCs) in Washington, DC, which provide care to a primarily African-American, publicly insured, underserved population.
The patients were assigned in nonrandomized fashion so that each practitioner treated patients with similar baseline characteristics, and patients with HCV monoinfection as well as those with HIV-HCV co-infection. Provider assignment was also made to minimize patient travel time to treatment, and to maintain their established relations with a health center.
Kattakuzhy and colleagues reported that response rates to a regimen of ledipasvir-sofosbuvir (Harvoni) were consistent across the 3 provider types, and that there were no major safety signals. SVR was attained in 89.3% of patients treated by nurse practitioners, 86.9% of those treated by primary care physicians, and 83.8 % treated by specialists. Patient loss to follow-up was the major cause of not attaining SVR.
"The take home message is that primary care providers can treat most HCV-infected patients independently in an office-based setting, with appropriate but concise training, and be confident that the vast majority of these patients will be cured," Kattakuzhy said.
She noted that, in the current era of chronic disease management options, physicians have the “rare opportunity” to eliminate potentially life-threatening disease.
“As such, primary care providers should advocate for full prescriber access to HCV medications without insurance-based restrictions," Kattakuzhy said.
The trial, "Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial," was published online in the Annals of Internal Medicine.