Summary
What is this summary about?
This is a summary of an article about an ongoing study called the BICSTaR study.
The BICSTaR study includes people with HIV (human immunodeficiency virus) who are taking a medicine called bictegravir/emtricitabine/tenofovir alafenamide (shortened to B/F/TAF). B/F/TAF is a single tablet that contains 3 different drugs for the treatment of HIV. The drugs work together to reduce the levels of HIV so that the virus can no longer be detected by a blood test.
People taking part in the study are adults with HIV living in Europe, Canada, Israel, Japan, South Korea, Singapore and Taiwan. People take 1 tablet of B/F/TAF once a day. They are either taking B/F/TAF as their first treatment for HIV, or they have switched to B/F/TAF from another HIV treatment.
Researchers looked at how well B/F/TAF worked and how safe it was in people who took B/F/TAF for a year.
What are the key takeaways?
Researchers found that B/F/TAF worked well in almost all people in the study by reducing levels of HIV in the blood. The virus could not be found in the blood of more than 9 out of 10 (94%) people who were taking B/F/TAF as their first HIV medicine and more than 9 out of 10 people (97%) who had taken another HIV medicine before starting B/F/TAF. This is known as having an ‘undetectable viral load’ and is a major goal for HIV treatment success. Researchers did not find any evidence of HIV developing resistance to B/F/TAF, which might stop B/F/TAF from working properly.
Around 1 out of 10 people (13%) had side effects (any unwanted sign or symptom that people have when taking a medicine that researchers think might be caused by the medicine) that might have been caused by B/F/TAF. Most of these side effects were not classified as serious. Less than 1 out of 100 (0.1%) people had serious side effects that might have been caused by B/F/TAF. Only 6 out of 100 people stopped taking B/F/TAF due to side effects caused by B/F/TAF. As a result, more than 9 out of 10 people (95%) took B/F/TAF for at least 1 year.
What were the main conclusions reported by the researchers?
B/F/TAF worked well in people with HIV in this study. Most people (around 9 out of 10) did not have any side effects.
Keywords: : Antiretroviral therapy, HIV medicine, lay language summary, plain language summary, real-world data, treatment-experienced, treatment-naïve
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Acknowledgments
We thank everyone involved in the study. We thank the participants in this study.
Author contributions
SE, AI, IL, AD'AM, JSL, BvW, KT, MB, C-EL, OAA, and OR contributed to study accrual, clinical care, and data recording; DT, MH, AM, MB, TC, LD'A, and RH contributed to trial management, data collection, and data analysis or interpretation; DT, MH, and RH contributed to study design. All authors reviewed and critically revised the summary, approved the final draft, and agree to be accountable for the summary's accuracy and integrity.
Financial disclosure
Stefan Esser: participated in advisory boards for Gilead, GSK, Janssen, MSD, ViiV Healthcare, and Theratechnologies; received honoraria from AbbVie, Gilead, Janssen, MSD, and ViiV Healthcare; received research funding from Gilead, Janssen, MSD, and ViiV Healthcare; and travel expenses from Gilead, Janssen, MSD, and ViiV Healthcare. Alexy Inciarte: received research funding from Gilead, GSK, and Janssen; participated in advisory boards for AbbVie, Almirall, Bayer, and Pfizer. All fees were paid to the institution. Itzchak Levy: consultant/advisor for Gilead, GSK, and MSD; expert testimony for GSK; received grants from Gilead and payment for lectures from Gilead, GSK, MSD, and Pfizer. Antonella D'Arminio Monforte: participated in advisory boards for Gilead, Janssen, MSD, Pfizer, and ViiV Healthcare; received honoraria from Gilead and ViiV Healthcare; received research funding from Gilead, Janssen, MSD, and ViiV Healthcare. John S. Lambert: has received an honorarium for a presentation/workshop supported by ViiV Healthcare. Berend van Welzen: participated in advisory boards for Gilead and ViiV Healthcare; received honoraria from Gilead and ViiV Healthcare; received research funding from Gilead. All fees were paid to the institution. Katsuji Teruya: received payment for lectures from Shionogi Pharmaceuticals. Marta Boffito: has received speaker and advisor fees and/or research grants (to her organization) from Cipla, Gilead, GSK, Janssen, Moderna, MSD, Mylan, Novavax, Pfizer, Roche, Valneva, and ViiV Healthcare. Ozlem A. Aydın: participated in advisory boards for Gilead and GSK; received conference sponsorship and speaker fees from AbbVie, Gilead, GSK, and MSD; received research funding from Gilead and GSK. All fees were paid to the institution.David Thorpe: employee of Gilead and owns shares in Gilead. Marion Heinzkill: employee of Gilead and owns shares in Gilead. Andrea Marongiu: employee of Gilead and owns shares in Gilead. Tali Cassidy: employee of Gilead and owns shares in Gilead. Richard Haubrich: former employee of Gilead and owns shares in Gilead. Lisa D'Amato: employee of Gilead and owns shares in Gilead. Olivier Robineau: consultant/advisor for Gilead Sciences, MSD, and ViiV Healthcare. Chun-Eng Liu: Nothing to disclose. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript.
Writing disclosure
Medical writing support was provided by Joanna Nikitorowicz-Buniak, PhD, and Christina Holleywood, PhD, from Aspire Scientific Limited and was funded by Gilead Sciences Europe Ltd.