B/F/TAF for HIV

Not yet recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial explores how people living with HIV who have recently moved to Quebec adapt to a new treatment called B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide). The trial aims to assess the practicality of this medication switch, participants' adherence, and their healthcare visits and insurance coverage. It seeks individuals who have been living with HIV, were born outside Canada, and have resided in Quebec for less than two years. Participants should have some experience with antiretroviral therapy (ART) for HIV, even if there were breaks in treatment. As a Phase 4 trial, this research helps determine how this FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Bictegravir/emtricitabine/tenofovir alafenamide?

Research shows that treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is generally well-tolerated in people with HIV. Studies have demonstrated that this combination is effective and safe, achieving high success rates in controlling the virus. For instance, one study found that after 12 months, 92% of participants had positive results without major issues. Another study reported a similar success rate of 93.8% after 48 weeks.

Importantly, these studies did not identify any major safety concerns. While some side effects may occur, they are usually mild and manageable. Since B/F/TAF is already approved and used for treating HIV, it has a well-known safety record. This makes it a reliable choice for patients considering participation in clinical trials with this medication. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The treatment regimen of Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is unique because it combines three powerful HIV medications into one convenient pill, taken once daily. This simplicity can significantly improve adherence compared to multi-pill regimens. Unlike some traditional treatments, B/F/TAF minimizes side effects and drug interactions while maintaining robust viral suppression. Researchers are particularly excited about its efficacy in diverse populations, like migrants who are ART-experienced, as it offers a streamlined and effective option for maintaining viral control.

What is the effectiveness track record for Bictegravir/emtricitabine/tenofovir alafenamide in treating HIV?

Research has shown that the medication Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), which participants in this trial will receive, is highly effective for treating HIV. One study found that 93.8% of patients had very low virus levels after 48 weeks, indicating well-controlled HIV. Another study reported it to be 92% effective after one year of treatment. Additionally, patients experienced a significant increase in CD4 cells, crucial for a strong immune system. Overall, B/F/TAF consistently demonstrates high rates of virus control, making it a strong option for people living with HIV. ^{2 6 7 8 9}

Who Is on the Research Team?

Bertrand Lebouché, MD, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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