The FDA ( U.S. Food and Drug Administration ) has approved Biktarvy ( Bictegravir 50mg / Emtricitabine 200mg / Tenofovir alafenamide 25mg, BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) for the treatment of HIV-1 infection.
Biktarvy combines the novel, unboosted integrase strand transfer inhibitor ( INSTI ) Bictegravir, with the demonstrated safety and efficacy profile of the Descovy ( FTC/TAF ) dual nucleoside reverse transcriptase inhibitor ( NRTI ) backbone, and is the smallest INSTI-based triple-therapy STR available.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed ( HIV-1 RNA less than 50 c/mL ) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
No dosage adjustment of Biktarvy is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
Biktarvy does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions.
Prior to or when initiating treatment with Biktarvy, healthcare providers should test for hepatitis B virus ( HBV ) infection and renal function, and monitor renal function as clinically appropriate during therapy.
Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B.
In clinical trials through 48 weeks, no patients taking the regimen of Bictegravir plus FTC/TAF developed treatment-emergent resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens.
In addition, the clinical data have shown that the regimen’s antiviral efficacy, tolerability profile and limited drug interactions offer an effective new treatment option for a range of people living with HIV.
The approval of Biktarvy is supported by data from four ongoing phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.
The trials are comprised of a diverse population of 2,415 participants, including a wide range of adult age groups and races/ethnicities.
Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies failed Biktarvy with treatment-emergent virologic resistance, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome.
The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache.
In Study 1489, a total of 629 treatment-naïve adults with HIV were randomized 1:1 to receive Biktarvy or Abacavir / Dolutegravir / Lamivudine ( 600/50/300mg ) ( ABC/DTG/3TC ).
At Week 48, 92.4% ( n=290/314 ) of patients taking Biktarvy and 93.0% ( n=293/315 ) of patients taking ABC/DTG/3TC achieved the primary endpoint of HIV-1 RNA less than 50 copies/mL.
In Study 1490, a total of 645 treatment-naïve adults with HIV were randomized 1:1 to receive Biktarvy or DTG+FTC/TAF.
At Week 48, 89.4% ( n=286/320 ) of patients taking Biktarvy and 92.9% ( n=302/325 ) of patients taking DTG+FTC/TAF achieved the primary endpoint of HIV-1 RNA less than 50 copies/mL.
In Study 1878, a total of 577 virologically suppressed ( HIV-1 RNA less than 50 copies/mL ) adults with HIV taking regimens of a boosted protease inhibitor ( bPI; Atazanavir or Darunavir ) plus a dual-NRTI backbone ( ABC/3TC or FTC/Tenofovir disoproxil fumarate ) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated Biktarvy once daily.
At the primary endpoint of week 48, switching to Biktarvy was non-inferior to continuing on a bPI regimen with 1.7% of patients in each group having HIV-1 RNA greater than or equal to 50 copies/mL; the proportion of patients with HIV-1 RNA less than 50 copies/mL was 92.1% in the Biktarvy arm and 88.9% in the bPI arm, according to FDA snapshot algorithm. ( Xagena )
Source: Gilead, 2018