Primary care treats chronic HCV just as well as specialists

June 9, 2016

PCPs can “play a decisive role in eradicating” hepatitis C virus in the U.S., says lead author of new study.

Primary care physicians (PCPs) can treat chronic hepatitis C virus (HCV) infections just as well as experienced specialists, according to a new study.

“HCV is in a new era of therapy. With direct-acting antivirals (DAAs) given as one pill per day, PCPs could manage treatment and therapy and play a decisive role in eradicating HCV in the U.S. and globally. We need universal policies that expand treatment access and more evidence-based guidelines,” lead author Sarah Kattakuzhy, MD, assistant professor at the Institute of Human Virology at the University of Maryland School of Medicine, told Medical Economics.

Kattakuzhy reported the results of the study (Abstract: LBP524) at The International Liver Congress 2016 in Barcelona, Spain, on April 13, 2016.

The multi-center, open-label clinical trial assessed 304 chronic HCV-infected patients at community health centers in the U.S. The patients received non-randomized treatment from a specialist provider, PCP, or nurse practitioner. The providers underwent uniform three-hour training on the Infectious Disease Society of America–American Association for the Study of Liver Disease guidelines for HCV.

Patients received the same standardized treatments with the DAAs ledipasvir and sofosbuvir, with outcomes assessed via unquantifiable HCV RNA viral load 12 weeks after the completion of treatment (SVR12) and by a composite score of attendance. The patients were predominantly black (96%) and genotype 1a (72%); one-quarter were co-infected with HIV and HCV, 18% were treatment experienced, and 20% had cirrhosis.

Results show that 285 patients achieved SVR12 (93.8% per protocol; 88.2% intention-to-treat including patients who discontinued medication early), with no significant difference identified between providers. SVR12 was achieved by 92.1% of patients receiving care from specialists, 96.7% of patients receiving care from PCPs, and 94.9% of patients receiving care from nurse practitioners.

 

“All three groups of providers had high SVR 12 rates in an urban, high-risk cohort that represents the foundation of HCV patients in the U.S. This was a real-world cohort treated under real-world circumstances,” said Kattakuzhy. “The results should give PCPs who are interested in providing HCV treatment the confidence that they can successfully manage these patients with just a little education and in a normal office setting.”

Previously, HCV patients needed a specialist to closely monitor and provide detailed care. “PCPs did not have the high degree of expertise or the time to administer these drugs, which were the equivalent to chemotherapy,” she said.

Kattakuzhy noted that “in most parts of country insurers restrict HCV treatment and providers. But these restrictions are not evidence-based. HCV therapy does not require a specialist for all patients.”

And there are not enough specialists to care for all HCV patients. “There are only 8000 infection disease/hepatology providers for the 2.7 million Americans infected with HCV. Obviously, we need more providers,” said Kattakuzhy.

What’s more, adherence to visits was higher among care provided by PCPs. “HCV care can be included in the management of other chronic diseases, such as diabetes and hypertension. For those patients without advanced fibrosis, HCV is a curable illness. There’s no evidence why PCPs could not treat them,” she said.

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