In a five-year follow-up analysis of people treated for hepatitis C in the ASCEND study, more than 90% ultimately achieved a sustained virological response (SVR), which is considered a cure. Outcomes were consistent across provider types, according to findings published in Open Forum Infectious Diseases. What’s more, reinfection rates were low five years after completing antiviral therapy.

When interferon-free direct-acting antiviral therapy became available in 2013, the high cost of the drugs led some private and public health insurers—including state Medicaid programs—to limit treatment access, for example, by requiring a period of abstinence from drugs and alcohol, only treating those with advanced liver fibrosis or requiring that treatment be managed by specialists such as hepatologists or infectious disease experts.

But studies have since shown that primary care providers and other nonspecialists can successfully manage hepatitis C care. Task-shifting to nonspecialists can increase access to care, as more people can be treated in more settings.

ASCEND was a Phase IV pilot study to assess the efficacy of community-based treatment for people with hepatitis C virus (HCV) alone or HIV/HCV coinfection in Washington, DC (ClinicalTrials.gov: NCT02339038). The trial initially found that antiviral therapy was effective regardless of provider type, but further follow-up was needed to determine long-term outcomes.

Sarah Kattakuzhy, MD, of the Institute of Human Virology at the University of Maryland School of Medicine, and colleagues compared long-term clinical outcomes when antiviral therapy was administered by a primary care provider, nurse practitioner or specialist physician. In particular, the researchers sought to determine whether rates of functional cure, HCV reinfection, retreatment and mortality varied based on provider type.

The analysis included 551 people at 12 urban health centers who were treated with Harvoni (ledipasvir/sofosbuvir) in 2015 as part of the ASCEND study. Nearly 70% were men, most (95%) were Black and the average age was approximately 60 years. A majority were treated for hepatitis C for the first time, and 20% were living with HIV.

The initial SVR rate was 87%. After five years of follow-up, 6.5% more were successfully treated, bringing the cure rate to more than 90%. These included individuals originally lost to follow-up whose subsequent testing confirmed a sustained response and those with successful retreatment after initial treatment failure.

“In the original ASCEND investigation, loss to follow-up was the primary reason for non-SVR,” wrote the researchers. “However, of individuals originally lost to follow-up who later had HCV RNA assessment, 76% were revealed to have achieved SVR.”

A majority of patients (70%) were tested for HCV reinfection at some point, 45% of them during the first year after being cured, 41% at least three years after successful treatment and some 10% five years after achieving SVR. During the five-year follow-up period, the researchers identified only two cases of reinfection. Twenty-five people died during the five-year period, five of them due to HCV-related causes.

SVR rates were similarly high for all provider types (primary care providers 85.2%, nurse practitioners 89.8%, specialist physicians 90.6%). There were no significant differences in reinfection, retreatment or mortality rates according to provider type.

“In this five-year follow-up evaluation of the ASCEND cohort, we found increased rates of SVR, high rates of retreatment and retreatment SVR, and minimal reinfection, independent of provider type,” wrote the researchers. “The results of this analysis affirm the long-term safety and efficacy of HCV treatment with DAA [therapy] by nonspecialist providers, emphasizing the durability of task shifting as a mechanism to address the HCV epidemic.”

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