In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks
SINGAPORE, Feb. 14, 2019 /PRNewswire/ — Gilead Sciences, Inc. today announced that the Singapore Health Sciences Authority has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*.
The triple-combination, single tablet regimen combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone – Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF). BIC/FTC/TAF has convenient once-daily dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.
"Having a drug regimen that has fewer screening requirements means that patients will be able to start their treatment course sooner, therefore positively impact a patient’s quality of life in the longer term. This is especially important as we see a steady rise of new HIV infections among the young (age 20 to 39)[1]," said Dr. Leong Hoe Nam, Private Infectious Disease Consultant, Mount Elizabeth Novena Hospital. "Starting treatment early on a regimen that offers durable viral suppression and high barrier to resistance also supports the long term health of patients."
The approval was based on data from four studies: Studies 1489 and 1490 in HIV-1 infected adults with no antiretroviral treatment history, and Studies 1844 and 1878 in HIV-1 virologically-suppressed adults who switched to Biktarvy. The trials are comprised of a population of 2,414 participants, and BIC/FTC/TAF met its primary efficacy objective at 48 weeks in all four studies, with no participants in any of the four BIC/FTC/TAF studies developing treatment-emergent virologic resistance. There were no cases of renal discontinuation, proximal renal tubulopathy or Fanconi syndrome in the BIC/FTC/TAF arms at 48 weeks. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhoea, nausea and headache.
"We believe that the availability of a standard of care therapy such as Biktarvy will be able to not only improve a patient’s quality of life, but also has to reduce transmission and eventually impact public health outcomes. We are pleased to work with Singapore’s health authorities to ensure patient access to safe and effective HIV treatments in the country," said Andrew Hexter, Vice President and General Manager, Asia 5, Gilead Sciences.
Additional ongoing studies not included in the marketing authorization application involve dedicated studies in women, adolescents and children.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018, the European Commission on June 21, 2018 and the Hong Kong Department of Health on September 26, 2018.
* BIC/FTC/TAF is a once-daily single tablet regimen (STR) indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
About Gilead Sciences, Inc. Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with global headquarters in Foster City, California.
Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing BIC/FTC/TAF for the treatment of HIV-1 infection and the possibility of unfavourable results from additional clinical trials involving BIC/FTC/TAF. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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[1] Ministry of Health, Singapore. Update on the HIV/AIDS situation in Singapore 2017 (June 2018). Available at: https://www.moh.gov.sg/resources-statistics/infectious-disease-statistics/hiv-stats/update-on-the-hiv-aids-situation-in-singapore-2017-(june-2018)
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