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

National Center for AIDS/STD Control and Prevention, China CDC

Status and phase: Not yet enrolling; Phase 4

Conditions: HIV; HIV Infection

Treatments: Drug: Regimen：BIC+FTC+TAF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06830668

CO-US-380-7381

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with 18 years old or above.
• Discontinuation of previous NNRTI based regimen for more than 90 days.
• No known CrCl< 30mL/min or severe hepatic impairment.
• No known or suspected resistance to BIC.
• No known pregnancy

Exclusion criteria

••Patients who are pregnant.

• Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl< 30).Hepatitis virus co-infection does not serve as an exclusion criterion.
• Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
• Patients who are psychiatric illness or active tuberculosis co-infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

AIDS patients who discontinued NNRTI for more than 90 days

Experimental group

Description:

HIV patients of any gender, older than 18 years of age, who have been off their prior NNRTI regimen for more than 90 days and who have an HIV-1 viral load greater than 50 copies/uL.In this study, eligible patients will restart treatment on the same day and receive B/F/TAF for one year.We will conduct follow-ups on the patients and carry out routine clinical tests.

Treatment:

Drug: Regimen：BIC+FTC+TAF