Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
Key facts
- Where
- Chian, ChinaSee the site
- Phase
- Phase 4
Where in China
- National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,BeijingChian, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Center for AIDS/STD Control and Prevention, China CDC
- Trial code
- NCT06830668
- Record updated
- 17 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC; 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 are psychiatric illness or active tuberculosis co-infection; ••Patients who are pregnant.