Theme: Clinical Research Year: 2023
Background:
OPPORTUNI-C was a pragmatic, stepped wedge cluster randomized trial evaluating the efficacy of opportunistic HCV treatment among hospitalized PWID. This abstract reports on sustained virologic response (SVR), the secondary outcome from this trial.
Methods:
Data was obtained by retrospective review of the electronic ‘core medical pharmacy record’ and microbiology files among individuals enrolled in OPPORTUNI-C, supplemented by HCV RNA testing using venipuncture or ambulant point of care HCV RNA (GeneExpert). SVR was defined as undetectable HCV RNA at least four weeks after the estimated date of end of treatment (SVR≥4). SVR was analyzed according to an intention to treat (ITT) principle among all enrolled individuals. Virologic failure was defined as detectable HCV RNA in any sample following end of treatment.
Results:
A total of 200 individuals were enrolled in OPPORTUNI-C, 98 during intervention conditions (immediate treatment) and 102 during control conditions (standard of care referral for outpatient care). ITT SVR was accomplished by 60 of 98 (61.2% [95% CI 50.8-70.9]) during intervention conditions and by 66 of 102 (64.7% [95% CI 54.6-73.9]) during control conditions (risk difference -3.5% [95% CI -16.9-9.9]; risk ratio 0.95 [95% CI 0.76-1.2]). Failure to achieve SVR was explained by lack of treatment in 41 (20.5%) loss to follow-up in 25 (12.5%), or virologic failure (i.e., relapse or reinfection) in 8 (4.0%). Among 159 participants who were dispensed the final DAA package from the pharmacy within data lock (i.e., treatment completion), 120 (85.1%) achieved SVR and 5 (3.6%) achieved end of treatment response, while SVR was accomplished by 33% (6 of 18) of those who were only dispensed the first package.
Conclusion:
Although SVR was similar during both conditions, it was limited by frequent loss to follow-up. Complete DAA dispensation from the pharmacy is a valid proxy for cure in this population.