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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infection; HIV
• Intervention / Treatment: Drug: Regimen：BIC+FTC+TAF

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yan Zhao, PhD; Phone Number: 010-58900930; Email: zhaoyan@chinaaids.cn

Study Locations

• China
  • Beijing
    • Chian, Beijing, China, 102206
      • National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing
      • Contact: Yan Zhao, PhD; Phone Number: 86-010-58900930; Email: zhaoyan@chinaaids.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AIDS patients who discontinued NNRTI for more than 90 days; 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.

Drug: Regimen：BIC+FTC+TAF; Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of re-initiation of B/F/TAF	Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (< 50 copies/ml).	From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug resistance status	Describe drug resistance status	From enrollment to the end of treatment at 48 weeks
The reasons for discontinuation of prior therapy	Describe the reasons for discontinuation of prior therapy	From enrollment to the end of treatment at 1 week
The efficacy of B/F/TAF	Evaluate the efficacy of B/F/TAF (achievement of HIV-1 RNA< 50 copies/ml and HIV-1 RNA < 200 copies/ml) among those participants rapidly restarting B/F/TAF	From enrollment to the end of treatment at Week 12, Week24 and Week 48
The persistence on B/F/TAF .	Evaluate the persistence on B/F/TAF during the study period and describe the reasons for discontinuation of B/F/TAF if it happens.	From enrollment to the end of treatment at 48 weeks
The changes in parameters of quality of life and treatment satisfaction	Describe changes in parameters of quality of life and treatment satisfaction	From enrollment to the end of treatment at Week24 and Week 48
The safety and tolerability on B/F/TAF	Evaluate the safety and tolerability on B/F/TAF during the study period.	From enrollment to the end of treatment at 48 weeks
The emergence of drug resistance	Describe the emergence of drug resistance developed during the study period.	From enrollment to the end of treatment at 48 weeks

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: HIV; HIV Infection
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: CO-US-380-7381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes