23 July 2019 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has presented findings from two Phase 3 trials a trial demonstrating the effectiveness of switching to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) in women, and a trial evaluating the potential for the single tablet regimen to be an effective treatment option in virologically suppressed patients with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse transcriptase inhibitors (NRTIs or NNRTIs), the company said.
The use of Biktarvy in patients with known drug resistance is investigational. These data were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City.
In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral treatment history.
While Biktarvy is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable antiretroviral regimen, these patients must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
On June 18, 2019, the US Food and Drug Administration approved labeling revisions to Biktarvy, expanding the patient population to include HIV-1 infected pediatric patients weighing at least 25 kg.
Biktarvy has a Boxed Warning in its US product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.
Key abstracts for Biktarvy data presented at IAS 2019 include:
Oral Presentation MOAB0106: Longer-term (96-week) efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in women
This international multicenter, randomized, open-label Phase 3 trial evaluated 470 virologically suppressed women on a baseline regimen of either Genvoya (elvitegravir/cobicistat/F/TAF; 150/150/200/10 mg), elvitegravir/cobicistat/F/TDF (150/150/200/300 mg) or atazanavir+ritonavir+F/TDF (300+100+200/300 mg) who switched 1: 1 from these baseline regimens to Biktarvy.
The primary endpoint for this study conducted exclusively in women, was previously presented, and demonstrated noninferior maintained virologic suppression, with a low frequency of serious adverse events and no emergent resistance at Week 48. All participants, including those on baseline regimens, switched to Biktarvy through Week 96.
At Week 96, 99.5% of women who received Biktarvy throughout the study duration and 98.5 % of women who switched to Biktarvy at Week 48 maintained virologic suppression (missing=excluded; M=E), with no development of treatment-emergent resistance.
Biktarvy was also shown to be well-tolerated with low frequencies of serious adverse events.
Oral Presentation MOAB0105: Switching to a single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir plus emtricitabine and either tenofovir alafenamide or tenofovir disoproxil fumarate (F/TAF or F/TDF)
This ongoing, randomized, double-blinded Phase 3 study evaluated 565 virologically suppressed adults who switched 1: 1 from a regimen of DTG+F/TAF (50+200/25 mg) or DTG+F/TDF (50+200/300 mg) to DTG+F/TAF or Biktarvy for 48 weeks.
Unlike previous studies which excluded participants with known resistance participants in this study with prior resistance to NRTIs, NNRTIs and/or protease inhibitors could enroll.
Only those participants with documented integrase inhibitor resistance were excluded, and 24% of participants had resistance to NRTIs.
The study's primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 c/ml at Week 48.
At Week 48, 0.4% (n=284) of participants on Biktarvy had HIV-1 RNA ≥ 50 c/ml, compared to 1.1 % of participants on DTG+F/TAF (n=281) (snapshot algorithm), demonstrating noninferiority.
In addition, at Week 48, no treatment-emergent resistance was detected, and no participants with pre-existing NRTI resistance mutations had HIV RNA >50 c/mL.
The use of Biktarvy in patients with known drug resistance is investigational and has not been determined to be safe or efficacious and is not approved by the US FDA.
Biktarvy does not cure HIV infection or AIDS.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA