HIV, HIV Infection
Conditions
Keywords
HIV, HIV Infection
Brief 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.
Interventions
DRUGRegimen：BIC+FTC+TAF
Same-day restart of BIC+FTC+TAF among HIV patients who experienced discontinuation from previous NNRTI-based regimens
Sponsors
Gilead Sciences
National Center for AIDS/STD Control and Prevention, China CDC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of re-initiation of B/F/TAF | From enrollment to the end of treatment at 24 weeks | Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (\< 50 copies/ml). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The reasons for discontinuation of prior therapy | From enrollment to the end of treatment at 1 week | Describe the reasons for discontinuation of prior therapy |
| The efficacy of B/F/TAF | From enrollment to the end of treatment at Week 12, Week24 and Week 48 | 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 |
| The persistence on B/F/TAF . | From enrollment to the end of treatment at 48 weeks | Evaluate the persistence on B/F/TAF during the study period and describe the reasons for discontinuation of B/F/TAF if it happens. |
| Drug resistance status | From enrollment to the end of treatment at 48 weeks | Describe drug resistance status |
| The safety and tolerability on B/F/TAF | From enrollment to the end of treatment at 48 weeks | Evaluate the safety and tolerability on B/F/TAF during the study period. |
| The emergence of drug resistance | From enrollment to the end of treatment at 48 weeks | Describe the emergence of drug resistance developed during the study period. |
| The changes in parameters of quality of life and treatment satisfaction | From enrollment to the end of treatment at Week24 and Week 48 | Describe changes in parameters of quality of life and treatment satisfaction |
Countries
China
Contacts
Primary ContactYan Zhao, PhD
Outcome results
None listed