B/F/TAF for HIV

Recruiting at 26 trial locations

Overseen By Gilead Study Team

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Gilead Sciences

Must be taking: Antiretrovirals

Disqualifiers: HIV resistance, Low eGFR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 48 weeks

177 Participants Needed

Trial Summary

What is the purpose of this trial?

The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on a stable antiretroviral regimen for at least 6 months before joining. If you are taking nevirapine or efavirenz, you should have stopped at least 14 days before enrolling.

What data supports the effectiveness of the drug B/F/TAF for treating HIV?

Research shows that the drug B/F/TAF is highly effective and well-tolerated for treating HIV, with studies demonstrating no new resistance to the treatment over 48 weeks. It has been effective in both men and women, including older individuals, and maintains its effectiveness even in patients with certain drug resistance mutations. ^{1 2 3 4 5}

Is B/F/TAF safe for humans?

B/F/TAF, a combination of bictegravir, emtricitabine, and tenofovir alafenamide, has been shown to be generally safe and well-tolerated in multiple studies for treating HIV-1. These studies included different groups, such as women and older adults, and reported no significant safety concerns over periods ranging from 48 to 240 weeks. ^{1 2 3 6 7}

How is the drug B/F/TAF unique for treating HIV?

B/F/TAF is a single-tablet regimen that combines three drugs, making it simple to take and highly effective for treating HIV. It has a high barrier to resistance, meaning the virus is less likely to become resistant to it, and it causes fewer side effects compared to some other treatments. Additionally, it is suitable for both adults and children, and it has potential use in pre- and post-exposure prevention. ^{1 3 4 5 8}

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for children and adolescents with HIV-1 who have been virologically suppressed for at least 6 months. It includes different age groups: those aged 12 to <18 years weighing ≥35 kg, those aged 6 to <12 years weighing ≥25 kg, and younger children down to infants of ≥1 month old with varying weight requirements. Participants must have a stable antiretroviral regimen, good kidney function (eGFR ≥90 mL/min/1.73 m^2), and no resistance to certain HIV medications.

Inclusion Criteria

I have been on a stable HIV medication regimen for at least 6 months.

My HIV does not resist common medications like FTC, TFV, or INSTIs.

I am a child with HIV, either new to treatment or have been on ARV for at least a month.

Exclusion Criteria

Other protocol defined Inclusion/Exclusion criteria may apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive B/F/TAF FDC tablets for oral suspension once daily through Week 48

48 weeks

Intensive PK evaluation at Week 2

Open-label extension

Participants in countries where B/F/TAF is not available may continue to receive the treatment until it becomes available

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Trial Overview The study tests various doses of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in fixed dose combinations for safety and how the body processes them. The goal is also to confirm the appropriate dosing for these age groups while monitoring their response to this combination therapy.

Participant Groups

Group I: Open-Label Extension Experimental Treatment 3 Interventions

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.

Group II: Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group III: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group IV: Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group V: Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Experimental Treatment 1 Intervention

Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.

Group VI: Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.

Group VII: Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.

Group VIII: Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

In a 96-week study involving 86 older adults (≥65 years) living with HIV, switching to the treatment B/F/TAF maintained high rates of viral suppression, with 94.2% of participants remaining virologically suppressed at week 72 and 74.4% at week 96.

The treatment was found to be safe, with no serious drug-related adverse events and stable CD4 counts, indicating that B/F/TAF is a viable long-term option for older adults with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people ≥65 years of age. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2023]

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated high efficacy in maintaining HIV-1 suppression, with 98.6% of participants achieving HIV-1 RNA levels below 50 copies/mL after 240 weeks of treatment.

The treatment was found to be safe, with only 1.6% of participants discontinuing due to adverse events, and no cases of treatment-emergent resistance were detected, indicating its long-term durability and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. Sax, PE., Arribas, JR., Orkin, C., et al.[2023]

In a study involving 631 treatment-naive adults with HIV-1, the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be non-inferior to the combination of dolutegravir, abacavir, and lamivudine at week 96, with 88% of participants achieving undetectable HIV-1 RNA levels.

Bictegravir was associated with fewer adverse events compared to dolutegravir, with only 28% of participants reporting drug-related side effects, and no participants discontinuing treatment due to adverse events, highlighting its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Wohl, DA., Yazdanpanah, Y., Baumgarten, A., et al.[2022]

In a 48-week study involving 86 older adults with HIV, switching to the medication bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) resulted in a high rate of virologic suppression, with 90.7% of participants maintaining HIV-1 RNA levels below 50 copies/ml.

The treatment was well tolerated, with no serious adverse events related to the drug and a high adherence rate of 98.6%, indicating that B/F/TAF is a safe and effective option for older adults living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people ≥65 years of age. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of bictegravir/emtricitabine/tenofovir alafenamide fixed dose combination and its potential in the treatment of HIV-1 infection: evidence to date. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV-1: What is the Hidden Potential of This Emerging Treatment? [2023]