The recent first global approval of bictegravir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

Bictegravir (Biktarvy®), developed by Gilead Sciences, received its first global approval in February 2018 in the USA as a fixed-dose combination, with emtricitabine and tenofovir alafenamide. It was approved for use as a complete treatment regimen in patients with HIV-1 infections who are naive to antiretroviral treatment, or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL), on a stable antiretroviral regimen for at least three months, without history of treatment failure or known substitutions associated with resistance to the individual components of the tablet.[3][4]

Bicktarvy® is administered as a single tablet comprising bictegravir, an unboosted, integrase strand transfer inhibitor (INSTI), a nucleoside reverse transcriptase inhibitor (emtricitabine), and a nucleotide reverse transcriptase inhibitor (tenofovir alafenamide; a prodrug of tenofovir). [2]

Although the prevalence of people with HIV 1 infections is the US is declining slightly over time, mainly resulting from targeted and effective therapy, almost 40,000 people were diagnosed with HIV in 2016 (more recent statistics not available).[5] Coincidentally, the approval date of the product was the National Black HIV/AIDS Awareness Day that is observed annually in the US to emphasize the disproportionate impact that HIV infections and AIDS have on the US Black population.[6]

Biktarvy is not designed to cure HIV, however it is expected that this once-daily, single tablet regimen will make keeping the disease under control more simple.

As John F. Milligan, PhD, Gilead’s President and Chief Executive Officer explained, the Company is “… committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients.” [4]

Approval of Biktarvy® was supported by two phase III studies in treatment-naïve patients[7][8] and two more in virologically suppressed adults.[9][10]

This fixed-dose combination product is also awaiting approval in the EU for the same indication.

Biktarvy® carries a boxed warning regarding the risk of post-treatment acute exacerbation of Hepatitis B Virus (HBV); healthcare professionals are advised to test and monitor for HBV infection prior to and during therapy. [3]

For further information related to the overall development of the fixed-dose combination and the individual composite drugs visit AdisInsight. [2][11][12]


Image credit:  Jess Watters on Unsplash

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.