Real-world effectiveness of doravirine-containing antiretroviral therapy in Chinese adults living with HIV-1: a retrospective study.

BACKGROUND

Doravirine (DOR)-containing antiretroviral therapy (ART) has been recommended as first-line ART by China treatment guidelines since 2021. However, Real-world studies on DOR in China are scarce. We evaluated the real-world effectiveness of DOR-containing ART in Chinese people with HIV-1 (PWH), including treatment-naïve people regardless of viral load (VL) at baseline and treatment-experienced people regardless if they were virologic suppression (VS) or not.

METHODS

This was a retrospective, multicenter, observational study using medical chart review in seven hospitals, covering top-tier infectious disease hospitals across regions in China. All the participants who initiated DOR-containing ART during August 2021 and September 2023 were included and followed until September 2024.

RESULTS

At baseline, higher proportions of the 352 participants were male (84.9%), from west region (78.7%), and mean age was 40.0 years. Of the 271 participants with available VL data to confirm the achievement of VS at week 48 ± 8 (271/352), 22.1% were treatment-naïve and 77.9% had prior antiretroviral experience. The adherence rate of DOR in the regimen or DOR/3TC/TDF single tablet was ≥ 80% in 91.5% of participants. Overall, DOR-containing ART achieved a VS rate of 93.7% (95% confidence interval: 90.8%, 96.6%), with rates of 90.0% and 94.8% observed in treatment-naïve and treatment-experienced participants, respectively. Notably, among all six treatment-experienced people who were unsuppressed at baseline, 100% of participants were suppressed at week 48 ± 8. DOR-containing ART appeared to be well tolerated among Chinese PWH, with an adverse event profile consistent with that described in product label.

CONCLUSION

DOR-containing ART is an effective treatment for Chinese PWH in real-world settings, regardless of their VLs and treatment experience at baseline.

CLINICAL TRIAL NUMBER: EUPAS (registration number: EUPAS103993), registered on [2023-03-23]; NMPA (registration number: CTR20231040), registered on [2023-04-10].