NCT06830668

Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation

Effectiveness and Persistence of Same-day Re-start with B/F/TAF Among Patients with HIV Who Experienced Discontinuation from Previous NNRTI Based Regimens in China

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.

Conditions

• HIV Infection
• HIV

Interventions

Type	Name	Description
DRUG	Regimen：BIC+FTC+TAF	Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-17
• Last updated: 2025-02-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study