BARCELONA, Spain — For patients with chronic hepatitis C, treatment administered by nonspecialist practitioners is as effective as that administered by specialists in hepatology or infectious diseases, new research shows.
The findings, presented in a late-breaking poster here at the International Liver Congress 2016, suggest a possible solution to the current "therapeutic bottleneck" in hepatitis C care, said lead investigator Sarah Kattakuzhy, MD, from the University of Maryland in Baltimore.
"Despite the therapeutic advances in hepatitis C, the care continuum is still experiencing some significant hurdles, namely in the form of trained and available specialist providers who traditionally administered hepatitis C therapy," she said.
The team conducted their study to see whether the relationship between primary care provider and patient is something that can be built on to ease the bottleneck, Dr Kattakuzhy explained.
Although the findings might ruffle the feathers of some specialist providers, "I believe that most specialists would agree that the global burden of hepatitis C greatly surpasses specialist provider capacity and has already overwhelmed our efforts to engage and treat patients with hepatitis C," she told Medscape Medical News.
"Certainly, more complicated hepatitis C patients not represented in this study should be managed by experienced specialists," she said, such as patients with decompensated liver disease and those who have failed treatment with direct-acting antiviral therapy. However, as this study shows, "the majority of hepatitis C patients treated with direct-acting antivirals will achieve cure, regardless of treating provider."
The investigators evaluated 600 patients with chronic hepatitis C from two community health centers in Washington, DC.
"These are areas that are medically underserved and the population is traditionally of low socioeconomic status," Dr Kattakuzhy explained.
The patients were assigned in a nonrandomized manner to one of 16 providers: five nurse practitioners; five primary care physicians (board-certified internists or family practice physicians); and six specialists (board-certified infectious disease or hepatology physicians).
All providers received a 3-hour training session on the treatment of hepatitis C; the information provided was in accordance with joint guidelines from the Infectious Diseases Society of America and American Association for the Study of Liver Diseases. A special focus was placed on the combination of ledipasvir and sofosbuvir, the treatment used in the study.
There were, in the study cohort, some "challenging subpopulations of the hepatitis C epidemic, including those with advanced fibrosis," Dr Kattakuzhy explained.
In fact, 23.7% of the patients were coinfected with HIV, 20% had cirrhosis, and about one-third had advanced fibrosis. In addition, 96.3% of the patients were black and 69.3% were men. Mean age was 58.7 years.
Patients were assessed at weeks 4, 8, 12, and 24. Most patients (89.8%) were prescribed a 12-week treatment regimen.
The study is ongoing, but in a preliminary per protocol analysis, rates of treatment response were "essentially equivalent," no matter who the provider was, Dr Kattakuzhy reported.
The sustained viral response at 12 weeks was 94.2% overall, 95.2% for those treated by a nurse practitioner, 97.3% for those treated by a primary care physician, and 92.7% for those treated by a specialist.
For patients coinfected with HIV, response at 12 weeks was 90.9%, and there was also no significant difference between provider groups.
All 22 patients who had viral relapse were infected with genotype 1a.
Of the 71 patients who discontinued therapy early, 53 were lost to follow-up and 10 were discontinued by the provider for medical or noncompliance reasons. Three patients died, but for reasons deemed to be unrelated to study participation.
There was a general decline in visit attendance over the study period. By week 12, roughly 61% of the patients were retained by their provider. However, cumulative attendance was significantly higher for nurse practitioners than for specialists (81.5% vs 63.8%; P = .0001).
"All of the providers were in the same health center, so this difference is not explained by patients having to travel further to see a specialist," said Dr Kattakuzhy. Part of the reason for the difference could be the multiple services provided by primary care doctors. "When you see a primary care physician, you can get your refill for your diabetes medication, you can talk to them about the ache in your back," she pointed out.
Widening the care model for patients with hepatitis C to include nonspecialists, even for traditionally harder-to-treat subpopulations, could "significantly expand the scale of therapy and bridge existing gaps in the hepatitis C care cascade," she pointed out.
These data are "extremely important in showing both the feasibility and efficacy of hepatitis C treatment in the primary care setting," said Andrew Aronsohn, MD, from the Center for Liver Diseases at the University of Chicago.
In an editorial cowritten by Dr Aronsohn, he and his colleague explain that unless patterns change, "referral for treatment to subspecialists and tertiary care centers will remain impractical, expensive, and inefficient. A key element will be to recruit trained, midlevel providers and primary care physicians as new treaters" (Hepatology. 2014;59:13-15).
In the era of direct-acting antivirals, "hepatitis C therapy is not only safe and highly effective, the relative ease of administration allows for widespread use outside of a specialist's office," Dr Aronsohn told Medscape Medical News.
"In this study, investigators have shown high rates of hepatitis C cure, whether care was managed by primary care physicians, nurse practitioners, or liver specialists." But, he added, the appropriate training of providers was an essential element in the study. "As in many other types of diseases, special care must be taken to identify those who are difficult to treat or are sick enough to require specialist attention."
Dr Kattakuzhy reports receiving funding from Gilead Sciences. Dr Aronsohn has disclosed no relevant financial relationships.
International Liver Congress (ILC) 2016: Abstract LBP-524. Presented April 15, 2016.
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Cite this: Nonspecialists Can Expand Treatment Access for Hepatitis C - Medscape - Apr 16, 2016.