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Posted On: 07/22/2019 2:14:15 PM
Post# of 154003
Yeah, it is important that they start with mono relatively soon, pending Phase 3 protocol approval by the FDA (and pending funding!).
In any case, Gilead is not sitting idle:
Gilead Sciences (GILD +0.3%) announces results from two Phase 3 clinical trials evaluating Biktarvy (bictegravir 50 mg/emtricitabine 200mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in women and drug-resistant HIV patients who switched from other treatments. The data were presented at the International AIDS Society Conference on HIV Science in Mexico City.
In one study, 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 without developing treatment-emergent resistance.
Results from the other study in patients who switched to Biktarvy from DTG+F/TAF or DTG-F/TDF regimens for 48 weeks, including some with prior resistance to NTRTs, NNRTIs and/or protease inhibitors, showed its non-inferiority (no worse than) to DTG+F/TAF at week 48. No participants with pre-existing NRTI resistance mutations has HIV RNA greater than 50 c/mL.
Biktarvy is not yet approved for treating HIV in patients with known drug resistance.
In any case, Gilead is not sitting idle:
Gilead Sciences (GILD +0.3%) announces results from two Phase 3 clinical trials evaluating Biktarvy (bictegravir 50 mg/emtricitabine 200mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in women and drug-resistant HIV patients who switched from other treatments. The data were presented at the International AIDS Society Conference on HIV Science in Mexico City.
In one study, 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 without developing treatment-emergent resistance.
Results from the other study in patients who switched to Biktarvy from DTG+F/TAF or DTG-F/TDF regimens for 48 weeks, including some with prior resistance to NTRTs, NNRTIs and/or protease inhibitors, showed its non-inferiority (no worse than) to DTG+F/TAF at week 48. No participants with pre-existing NRTI resistance mutations has HIV RNA greater than 50 c/mL.
Biktarvy is not yet approved for treating HIV in patients with known drug resistance.
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