GRAND PLAN: Safety and Efficacy of Glecaprevir/Pibrentasvir for the Treatment of Hepatitis C Virus Infection Among People Initially Disengaged From Health Care Who Use Drugs-A Systematic Multidisciplinary Approach.

Autor: Conway B; Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada.; Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada., Yi S; Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada., Yung R; Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada., Sharma S; Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2024 Mar 05; Vol. 11 (3), pp. ofad638. Date of Electronic Publication: 2024 Mar 05 (Print Publication: 2024).
DOI: 10.1093/ofid/ofad638
Abstrakt: Background: GRAND PLAN is a prospective, open-label, phase 4 study. Based at a single center and with a single arm, GRAND PLAN evaluated the safety and efficacy of an 8-week course of glecaprevir/pibrentasvir (G/P) among active drug users with hepatitis C virus (HCV) infection in a population enriched for factors that may reduce treatment uptake and success, such as disengagement from health care and unstable housing.
Methods: Participants were ≥19 years old and actively using drugs and were confirmed viremic, noncirrhotic, and HCV treatment naive. All participants provided informed consent before any study procedures. They received G/P for 8 weeks within a multidisciplinary model of care, with daily, weekly, or monthly dispensing of medications to optimize adherence.
Results: We identified 117 eligible patients with a median age of 46 years (range, 22-75): 27% were female, 21.4% were Indigenous, 48.7% were unstably housed, and 95.7% were active drug users (94.9% fentanyl). One patient did not start treatment, and 4 underwent <1 week of treatment, leaving 112 completed treatments with 94.6% picking up medications weekly. HCV RNA was undetectable at the end of treatment in all 112 patients. One died of unknown causes shortly after treatment. A cure was demonstrated in 108 of 111 (97.3%) cases at the SVR12 time point (sustained virologic response at ≥12 weeks); the other 3 experienced virologic relapse. Considering the entire cohort, the intent-to-treat success rate was 92.3% (108/117). HCV reinfection was documented at SVR24 in 5 cases, 2 of which were successfully retreated.
Conclusions: GRAND PLAN demonstrates that administration of an 8-week course of G/P to inner-city residents with HCV infection leads to a cure >95%. With a short course of treatment, G/P is an attractive option for this population in helping us achieve the World Health Organization's HCV objectives by 2030.
Competing Interests: Potential conflicts of interest. B. C. received research grants, honoraria, and consultation fees from AbbVie, Astra Zeneca, Gilead Sciences, Indivior Canada, Merck, Moderna, Sanofi Pasteur, Seqirus, and ViiV Healthcare. S. S. received honoraria and consultation fees from AbbVie and Gilead Sciences. All other authors report no potential conflicts.
(© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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