Hepatitis C (HCV) can cause both acute and chronic health implications, including serious health threats if left untreated. In 2018, the Centers for Disease Control and Prevention (CDC) reported 15,713 deaths related to HCV, which likely represents a significant under-reporting. It is estimated that over 2.4 million people are living with HCV in the United States, which requires ongoing treatment and surveillance.1
Often though, people may not realize they have HCV or even how it’s spread. Most commonly spread through direct contact with infected blood, transmission can also occur from sharing drug-injection equipment, healthcare exposures, unregulated tattoos or body piercing without sterilized equipment, and even sex with an infected person. In fact, 6% of infants born to mothers with HCV will develop the disease.
Like so many infectious diseases with the potential for chronic illness, the capacity to ensure access and adherence to treatment is critical. A new study published in JAMA sought to address HCV care through initiating treatment at the point-of-diagnosis within the community, aimed specifically at marginalized populations through a nonrandomized controlled trial. The goal was simple—try to improve direct-acting antiviral treatment uptake in populations underrepresented and underserved. Considering that HCV prevalence is high and on a global scale 57-71 million people are living with it, the implications could be hugely significant for larger public health efforts.2
What You Should Know
The NOW study demonstrates the effectiveness of initiating Hepatitis C treatment at the point of diagnosis. By providing a two-week starter package of direct-acting antivirals (DAAs) immediately after a positive HCV test result, the study aimed to reduce the gap between diagnosis and treatment initiation.
The study specifically targeted marginalized populations, such as individuals experiencing homelessness and injecting drugs.
The study reported a high rate of treatment completion, with 79% of participants completing the 12-week sofosbuvir-velpatasvir treatment.
Direct-acting antivirals (DAAs) help treat HCV quite significantly and cure rates are reported to be close to 100%. And in this new study, No One Waits (NOW), investigators followed the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) reporting methods. The study occurred from July 1, 2020 to October 31, 2021 in street-outreach recruitment in people experiencing homelessness and injecting drugs in urban, nonmedical community in San Francisco, California.
The NOW model provided a two-week starter package of 400 mg of sofosbuvir and 100mg of velpatasvir when results were disclosed (done via screening through the OraQuick HCV Rapid Antibody test and then on-site venipuncture for HCV RNA). Following this, participants would be given insurance-provided sofosbuvir-velpatasvir when possible to ensure a 12-week treatment protocol. The authors noted that, “Of the 492 people (median [IQR] age, 48 [37-58] years; 62 [71%] male) who underwent anti-HCV testing, 246 (50%) tested anti-HCV positive, and 111 (23%) tested HCV RNA positive and were eligible for simplified HCV treatment. Eighty-nine of the 111 eligible participants (80%) returned for confirmatory RNA results, and 87 (98%) accepted and initiated HCV treatment. Seventy (80%) were currently injecting drugs, 83 (97%) had an income below the poverty line, and 53 (61%) were currently unsheltered. Most had HCV genotype 1a (45 [52%]) or 3 (20 [23%]). Sixty-nine (79%) completed 12 weeks of sofosbuvir-velpatasvir treatment, 2 stopped treatment because of low adherence, and 16 were lost to follow-up.”2
For those 66 individuals who fully completed treatment and had a blood draw, 92% yielded undetectable HCV RNA, which is immensely successful. The research team noted that within the treatment group (87 patients), 58 achieved SVR12 with a treatment response of 67%. No adverse events, late exclusions, or deaths were reported, and as the authors emphasized, this nonrandomized controlled trial underscored the success that the NOW model can have, especially within underserved and marginalized populations.
Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved SVR12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intention-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group. There were no adverse events, late exclusions, or deaths.”2
References
1. Viral Hepatitis, Q&As for the Public. CDC. Updated October 31, 2023. https://www.cdc.gov/hepatitis/hcv/cfaq.htm#overview
2. Morris MD, McDonell C, Luetkemeyer AF, Thawley R, McKinney J, Price JC. Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023;6(10):e2338792. doi:10.1001/jamanetworkopen.2023.38792
