Theme: Epidemiology & Public Health Research Year: 2017
Background: Directly observed therapy (DOT) is established as a means of ensuring medication compliance in many different therapeutic areas. In Glasgow, opiate replacement therapy (ORT) is prescribed as DOT when patients are still injecting, or in the early stages of recovery. This allows an opportunity to co-administer direct acting antivirals (DAAs), and treat patients historically considered more difficult to treat. We report results from our experience with partial DOT of a twice daily regimen of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin (3D/2D).
Methods: Patients starting on 3D/2D prior to 31/09/2016 in Glasgow were identified from the Scottish HCV database. Age, PWID status, intended and actual treatment duration and SVR12 were collected. Data were linked to pharmacy records to identify location and frequency of DAA dispensing. Non community pharmacy treatments (prison or hospital) were excluded. Baseline data and outcomes for patients on DOT were compared with patients dispensed DAAs weekly or fortnightly (non-DOT). For DOT, the morning dose was supervised and second dose dispensed for offsite dosing.
Results: 173 patients met the inclusion criteria: 31 DOT and 142 non-DOT. DOT patients were younger, and more likely to be PWIDs. Premature discontinuation rates were similar amongst both groups (2/31 (6.5%) vs 10/142 (7.0%)). Of 158 patients attending for SVR bloods, SVR rates were similar between DOT (27/28 (96.4%)) and non-DOT (122/130 (93.8%)). Of 9 virological failures, 8 had prematurely discontinued therapy and 1 had documented missed doses (non-DOT arm).
Conclusions: DOT of DAAs with ORT allows patients who are still injecting or in the early stages of recovery to be treated safely and effectively with DAAs. Rates of premature discontinuation were higher than in clinical trials, but comparable to non-DOT patients. The requirement for patients to take the second daily dose offsite did not impact on SVR rates, suggesting good compliance.