Researchers at the University of California, San Francisco, report positive results from the No One Waits study.
People experiencing homelessness and people who inject drugs (PWID) achieved successful hepatitis C virus (HCV) treatment outcomes and sustained virologic response (SVR) 12 weeks after starting treatment at the point of diagnosis in a nonclinical setting.
Meghan Morris, Ph.D., of the Department of Epidemiology and Biostatistics at the University of California, San Francisco, and colleagues conducted a study, the results of which were published in JAMA Network Open last month examining whether an HCV test-and-treat model may prove effective in marginalized communities that have otherwise been unable to overcome barriers to testing and treatment.
Ideally, access to healthcare should not be hindered by the barriers of inconvenience or travel. Unfortunately, many individuals around the world face challenges in accessing the healthcare they require. One specific area where access to healthcare is crucial is in the treatment of HCV.
HCV is a viral infection that affects the liver and can lead to severe health complications if left untreated. It is estimated that over 70 million people worldwide are infected with Hepatitis C, with a significant number of them facing difficulties in accessing the necessary treatment. Marginalized populations in the United States, including PWID, account for more than 80% of HCV infections. The incidence of HCV infections has increased in the U.S. due to the opioid epidemic.
Traditionally, the diagnosis and treatment of HCV have been centralized in healthcare facilities, making it challenging for individuals in remote or underserved areas to receive proper care. Now, though, some care is shifting to community-based, point-of-diagnosis treatment, which aims to bring healthcare services closer to those who need them.
Community-based, point-of-diagnosis treatment involves integrating testing and treatment services into community settings such as primary care clinics, community health centers, and outreach programs. This approach eliminates the need for patients to travel to specialized healthcare facilities, increasing access to care and reducing barriers.
There are several benefits to community-based point-of-diagnosis HCV treatment. It allows for early detection and treatment, leading to better health outcomes. By bringing testing and treatment closer to the community, individuals are more likely to seek medical help at an earlier stage, increasing the chances of successful treatment and reducing the risk of complications.
Community-based treatment programs may help address the stigma associated with HCV. Many individuals are hesitant to seek testing and treatment due to the fear of judgment or discrimination, according to researchers. By providing services in familiar and non-threatening community settings, people may feel more comfortable seeking assistance, which can help reduce the stigma surrounding the disease.
The wide availability of direct acting antivirals (DAAs) has resulted in better access to treatment and improved treatment compliance. Additionally, HCV treatment with DAAs has pushed SVR/cure rates toward 100%. Although clinical guidelines recommend treatment for all adults living with HCV, the low treatment uptake among marginalized populations, including PWID remains a significant concern.
Morris and colleagues reported results from the No One Waits (NOW), a single-arm nonrandomized controlled trial to assess the feasibility, acceptability and safety of providing HCV treatment at the time of diagnosis in a nonclinical community setting. The primary end point was SVR12 at post-treatment week 12 or later. The secondary end points included undetectable HCV RNA at treatment completion.Treatment discontinuation either from late exclusion criterion or adverse event was the measured safety end point.
The participants received HCV testing, disclosure of diagnosis, and treatment in a nonclinical site. Participants were offered a starter pack of Epclusa (sofosbuvir and velpatasvir) upon disclosure of HCV RNA results. They transitioned to insurance-provided medication for a 12-week treatment course when feasible.
The study enrolled 492 participants, with 50% testing positive for antibodies against HCV and 111 participants (23%) eligible for simplified HCV treatment. Of the participants (80%) who returned for their RNA results, 98% accepted and initiated treatment. Furthermore, 79% successfully completed 12 weeks of treatment. Among the treated patients, 67% achieved SVR 12 weeks after treatment in the intention to treat group. No adverse events, late exclusions, or deaths were reported during the study.
Findings suggested that the point-of-diagnosis treatment model utilized in the study reduced barriers to HCV treatment initiation and led to high levels of treatment initiation, completion, and cure. Simplified HCV treatment algorithms can empower non-HCV specialist healthcare providers to deliver DAA treatment, and innovative approaches aim to lower barriers for PWID. The study highlighted the potential of this model to expand HCV test-and-treat efforts by reaching marginalized communities and furthering curative therapy.
Morris and colleagues stress the importance of expanding HCV test-and-treat efforts to reach marginalized populations and overcome the barriers they face in accessing HCV treatment. The authors added “With additional resources dedicated to improving HCV diagnosis, access to DAA treatment….as outlined in the US National Hepatitis C Elimination Program, our model can be implemented in community based settings and other areas of colocalized services in other cities.”