For initial therapy, an integrase strand transfer inhibitor plus 2 nucleoside reverse transcriptase inhibitors is generally recommended; the treatment choice should be guided by unique patient circumstances.
Symtuza is the first complete darunavir-based single-tablet regimen to be approved.
The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.
The researchers found that depression or suicidal ideation did not differ at baseline for patients ever exposed to efavirenz versus those never exposed to efavirenz and receiving nevirapine.
The labeling now states that Prezcobix is not recommended for use in pregnant women due to substantially lower exposures of the active ingredients, darunavir and cobicistat, during pregnancy.
The authors found that vaccination rates varied between 1.5% and 42.4% at the 6 institutions assessed and that 21.3% of eligible patients at the University of Colorado received HZV prior to the intervention.
The Agency has received reports of serious neural tube birth defects involving the brain, spine, and spinal cord in babies born to women who received dolutegravir for HIV treatment.
The use of Truvada for PrEP in the adolescent population was based on a single-arm, open-label clinical study (ATN113) among 67 HIV-1 negative young men (aged 15 to 17 years) who have sex with men (YMSM).
The safety and efficacy of Trogarzo were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs.
Biktarvy combines bictegravir, an integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), two nucleoside reverse transcriptase inhibitors (NRTIs).
