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Rapid HCV Testing and Treating Young
Drug Injectors Yields Higher SVR12
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AASLD, The Liver Meeting, November 12-15, 2021
Mark Mascolini
Sustained virologic response 12 weeks after anti-HCV treatment ended (SVR12) proved significantly higher after 12 months in young drug injectors randomized to same-day evaluation, testing, and getting a 7-day sofosbuvir/velpatasvir starter pack than in those randomized to usual care in a pilot trial, HCV-Seek Test & Rapid Treatment (HCV-ST&RT) [1]. The researchers believe quick treatment coupled with less monitoring may be a promising strategy for hard-to-reach young people who inject drugs.
Researchers from New York University and colleagues at other New York institutions noted that direct-acting antivirals (DAAs) that can cure HCV infection have been slow to reach younger people, especially young people who inject drugs. For this challenging population, accumulating research supports a strategy of fewer initial lab tests, quick access to DAA therapy suitable for all HCV genotypes, and less on-treatment monitoring. HCV-ST&RT aimed to assess the effectiveness of such a simplified, rapid HCV treatment model in young current drug injectors.
This open-label (nonblinded) pilot trial at a single site-a community-based syringe service program-recruited 18- to 29-year-olds who injected drugs within the last 30 days, tested positive for HCV antibody, and had never received anti-HCV therapy. HCV RNA test results were not available until after randomization. The trial took place from October 2018 through March 2021, and the primary endpoint was percentage of participants achieving SVR12 within 12 months of enrollment.
At the first study visit (on day 0) people randomized to rapid treatment had a medical evaluation and baseline lab testing and got a sofosbuvir/velpatasvir 7-day starter pack. On days 2 to 7, participants had an in-person or phone discussion about HCV RNA test results and baseline lab data. Those positive for HCV RNA tapped their starter pack to begin treatment. The usual-care control arm followed the same procedure, except that instead of beginning treatment with a starter pack if positive for HCV RNA, they received facilitated referral to local providers.
On treatment day 7 in the rapid treatment group, participants could pick up or get delivered a 21-day medication pack. On day 28 they repeated lab tests and got 56 days of medication. Twelve weeks after treatment ended, all participants had another HCV RNA test to determine if sofosbuvir/velpatasvir had cleared HCV.
Nineteen young drug injectors got randomized to rapid treatment and 20 to usual care. Five people in the rapid arm tested negative for HCV RNA or withdrew before starting treatment, leaving an intention-to-treat population of 14. Nine people in the usual-care group tested negative for HCV RNA, leaving 11.
Age averaged 26.1 in the rapid group and 25.4 in the usual-care group. Respective proportions of women were 21.4% and 27.3%, whites 42.9% and 54.5%, Hispanics 42.9% and 27.3%, and homeless any time in the last 90 days 14.3% and 36.4%. The rapid group averaged 18.2 days injecting in the last 30 days and the usual-care group 16.9 days.
In the 12-month intention-to-treat analysis, 9 of 14 people in the rapid treatment group attained SVR, compared with 1 of 11 in the usual-care group, a significant difference (64.3% vs 9.1%, P = 0.01). Of the 5 people who did not reach SVR12 in 12 months in the rapid group, 2 had continuing viremia and 3 missed their viral load test. Of the 10 people who did not reach SVR12 in the control group, all had continuing viremia. Among 13 people who began DAA therapy in the rapid group, 9 (69.2%) attained SVR12, 1 (7.7%) had treatment failure, and 3 (23.1%) had an unknown outcome. Among 3 people who started DAAs in the usual-care group, 1 attained SVR12 and 2 had treatment failure.
Among the 14 people testing positive for HCV RNA in the rapid treatment group, 14 had an initial visit with an HCV provider, 14 completed baseline lab testing, 13 started treatment, 12 completed treatment, and 9 achieved SVR12. Among the 11 people with a positive HCV RNA test in the usual-care group, 5 made an initial provider visit, 5 completed baseline lab testing, 3 started therapy, 1 completed therapy, and 1 reached SVR12.
Of the 13 rapid treatment participants who started therapy, median time from enrollment to starting was 5 days (range 3 to 89) and from HCR RNA confirmation to starting 1 day (range 0 to 81).
The HCV-ST&RT investigators proposed that "meeting young people who inject drugs where they're at, and initiating HCV treatment 'in the moment' without the need for repeat visits (minimal monitoring), appears to be a promising strategy for treating this hard-to-reach population." The results clearly need confirmation in larger trials.
Reference
1. Eckhardt BJ, Kapadia SN, Pai M, et al. Rapid hepatitis C treatment initiation in young people who inject drugs: final results from the HCV-SEEK, TEST & RAPID TREATMENT (HCV-ST&RT) randomized pilot clinical trial. AASLD, The Liver Meeting, November 12-15, 2021. Parallel session 14: Hepatitis C Oral Session.
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