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Bifast study: efficacy and safety of immediate start of BIC/FTC/TAF after HIV diagnosis: Aws Waleed M. Al-Hayani, ECCMID 2023

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Published Online: Apr 18th 2023

After HIV diagnosis, antiretroviral therapy is indicated to be started as early as possible, the phase 4 Bifast study looked at the efficacy and safety of BIC/FTC/TAF when initiated at the first HIV-specialist appointment. In this interview with Dr. Aws Waleed M. Al-Hayani (Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain) we discuss the controversies surrounding the immediate start of antiretroviral therapy in HIV, the aims, design, inclusion criteria and findings from the Bifast study and the benefits of using patient-reported outcomes in HIV clinical trials.

The abstract ‘The Bifast Study: 24 weeks data of starting BIC/FTC/TAF with or without baseline data in treatment naive patients with HIV infection.’ (Abstract number: P2798) was presented at ECCMID 2023, 15-18 April, 2023, Copenhagen, Denmark.


  1. What controversies surround the immediate start of antiretroviral therapy (ART) in HIV? (0:15)
  2. What are the benefits of using patient-reported outcomes in HIV clinical trials? (1:27)
  3. What were the aims, design and inclusion criteria of the phase 4 Bifast study? (2:01)
  4. What were the findings at week 24? (3:21)
  5. What impact will these findings have on clinical practice and patient quality of life? (3:49)

Disclosures: Aws Waleed M. Al-Hayani has nothing to disclose in relation to this video interview.

Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Katey Gabrysch and Victoria Jones.

Filmed in coverage of the 33rd European Congress of Clinical Microbiology & Infectious Diseases.

Click here for more content on HIV & for further ECCMID 2023 highlights visit here.


What controversies surround the immediate start of antiretroviral therapy (ART) in HIV? (0:15)

The collective benefits from the starting of HIV treatment is that the patient then gets undetectable levels of viral load and cannot be a potential source of transmission for the infection. So immediate initiation of antiretroviral treatment has been also associated with increased retention in HIV care and also with higher proportion of people living with AIDS with undetectable viral loads at 48 weeks. This data or all of this data are from developing countries, but in Europe and the Western countries, data are lacking. But the data we have a longer rapid initiation of antiretroviral treatment says that it’s a safe and effective strategy, and especially if we start with a regimen containing inhibitors/ transfer inhibitor.

What are the benefits of using patient-reported outcomes in HIV clinical trials? (1:27)

When we use the patient reported outcomes in our clinical practice, that could offer us a valuable insight into a patient’s subjective experience and quality of life. Providing to us a more comprehensive understanding of how a patient will be, adherencr to therapy and also give us a retrospective satisfaction with the care that the patient could have.

What were the aims, design and inclusion criteria of the phase 4 Bifast study? (2:01)

We conducted our phase four open label non-randomized single centre clinical trial in our hospital from the Fundación University hospital, which is a referral HIV clinic downtown in Madrid. And we included consecutive patients, which included 98 patients newly diagnosed with HIV. And they were all offered a same day treatment with whether or not having the baseline laboratory data. The group one started the treatment without the lab data and the group two started the treatment with the lab data. The aim of this study was to assess the impact of this initiation of antiretroviral treatment at the first visit with the infectious disease specialist with ART on a single tablet daily regimen. And we evaluate the safety, efficacy defined as the level of HIV1-RNA less than 50 copies and benefits from the procedure PRO based on reported outcomes of the week 24.

What were the findings at week 24? (3:21)

Well, basically we found that the starting of the antiretroviral treatment at the first HIV specialist appointment will determine whether or not having the laboratory data is a safe and effective strategy with also a significant impact on the quality of life perceived by the patients within the first week of the treatment.

What impact will these findings have on clinical practice and patient quality of life? (3:49)

The rapid or the immediate initiation of antiretroviral treatment with regions like BIC/FTC/TAF, which is an effective treatment and it’s a very well-tolerated regimen and it’s a drug with very infrequent interactions. All of this, these things could lead to better outcomes, not only in achieving an undetectable viral load, but also in improving the quality of life because it’s a very well-tolerated regime.

Subtitles and transcript are autogenerated.

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