B/F/TAF for HIV

Overseen By David Lessard, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Antiretrovirals

Must not be taking: Integrase inhibitors

Disqualifiers: Pregnancy, Substance use, Tuberculosis, Hepatitis, 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: Unknown

Duration: 48 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you cannot use drugs that have contraindications or interactions with B/F/TAF. It's best to discuss your current medications with the study team to see if any adjustments are needed.

What data supports the effectiveness of the drug Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for treating HIV?

Research shows that B/F/TAF is effective for treating HIV, with studies demonstrating high efficacy and safety in both older adults and women, as well as in initial treatment and when switching from other therapies. The drug has been shown to maintain viral suppression without developing resistance over extended periods. ^{1 2 3 4 5}

Is B/F/TAF safe for humans?

B/F/TAF has been studied in several clinical trials for HIV treatment, showing it is generally safe and well-tolerated in both younger and older adults, including women. These studies have not reported any new safety concerns over periods ranging from 48 to 240 weeks. ^{1 2 3 4 6}

What makes the drug B/F/TAF unique for treating HIV?

B/F/TAF is unique because it is a single-tablet regimen that combines three drugs, making it easier to take. It has a high barrier to resistance, meaning the virus is less likely to become resistant to it, and it is well-tolerated with fewer side effects and drug interactions. It is also effective in children and those with certain drug resistance mutations. ^{2 4 7 8 9}

What is the purpose of this trial?

This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).

Research Team

Bertrand Lebouché, MD, PhD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

The ASAP-Switch Study is for migrant individuals living with HIV. Participants will have their treatment switched to a medication called B/F/TAF and the study aims to understand their experience with this change, including how well they stick to it and their overall care.

Inclusion Criteria

I have taken HIV medication before, with or without breaks.

Willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to performing study procedures

I am not pregnant and do not plan to become pregnant in the next year.

Exclusion Criteria

Pregnant, breastfeeding, or planning to become pregnant

Known hypersensitivity to B/F/TAF, its metabolite or formulation excipient

Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants' antiretroviral treatment is switched to B/F/TAF, provided free of charge

48 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Extension

Participants continue to be monitored for viral suppression and healthcare coverage changes

72 weeks

Treatment Details

Interventions

• Bictegravir/emtricitabine/tenofovir alafenamide

Trial Overview This study tests the switch of HIV treatment to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). It looks at how feasible and acceptable the switch is for migrants, adherence levels, healthcare interactions, and insurance coverage aspects.

Participant Groups

Group I: Antiretroviral Speed Access Program Switch Experimental Treatment 1 Intervention

HIV (type 1) infected adults born outside of Canada (migrants) and recently moved to province of Quebec (less than 2 years), ART-experienced, newly referred at the study sites.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

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]

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]

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 of 136 virologically suppressed Asian participants living with HIV, switching to the regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) resulted in 100% virological suppression at week 48, with no treatment-emergent drug resistance observed.

The safety profile of B/F/TAF was comparable to that of participants who continued their baseline regimens, with no serious adverse events reported and a significant reduction in tubular proteinuria for those switching from tenofovir disoproxil fumarate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. Avihingsanon, A., Chetchotisakd, P., Kiertiburanakul, S., 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]

References

1. 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]

2. 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]

3. 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]

4. 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]

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

Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. [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

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

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]

9. England pubmed.ncbi.nlm.nih.gov

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