Biktarvy: Bictegravir, Emtricitabine, Tenofovir Alafenamide approved by FDA for treatment of HIV-1 infection
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.
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 c/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 c/mL.
In Study 1878, a total of 577 virologically suppressed ( HIV-1 RNA less than 50 c/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 c/mL; the proportion of patients with HIV-1 RNA less than 50 c/mL was 92.1% in the Biktarvy arm and 88.9% in the bPI arm, according to FDA snapshot algorithm. ( Xagena )
Source: Gilead, 2018
The nucleoside-modified messenger RNA in COVID-19 mRNA vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA...
Opdivo plus Yervoy for patients with hepatocellular carcinoma previously treated with Sorafenib, FDA approved
Opdivo ( Nivolumab ) 1 mg/kg plus Yervoy ( Ipilimumab ) 3 mg/kg ( injections for intravenous use ) was...
Initial preliminary findings from the Papa Giovanni XXIII Hospital sponsored SISCO ( Siltuximab In Serious COVID-19 ) Study, based on...
Adults and children with all genotypes of hepatitis C and compensated cirrhosis: Mavyret shortens duration of treatment to eight weeks, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir )...
Results from the largest study of hepatitis B and C and HIV infection prevalence in cancer patients show an alarmingly...
FDA has approved Dovato, the first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
The FDA ( U.S. Food and Drug Administration ) has approved Dovato ( Dolutegravir and Lamivudine ), as a complete...
Dovato, based on Dolutegravir and Lamivudine, a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection, approved in European Union
The European Commission has granted Marketing Authorisation for Dovato ( Dolutegravir / Lamivudine ) for the treatment of HIV-1 infection...
The results of a study has shown that patients living with HIV and one of a variety of potentially deadly...
HIV-1 control with a 2-drug regimen of Dolutegravir plus Lamivudine in virally suppressed patients switching from a TAF-containing 3-drug regimen
Week 48 results from phase III TANGO study were announced. The TANGO study was conducted to assess whether adults living...