Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals.

Lower odds of having detectable viral load for older adults and those using ISTI-based regimen

The ATLAS study enrolled 570 patients infected with HIV-1; participants were randomized to either the experimental or active comparator arms.

If Tybost is given with atazanavir or darunavir, coadministration with rivaroxaban is not recommended due to a potentially increased bleeding risk.

The Dosage and Administration section has been revised to state that Mavyret is recommended for 12 weeks in liver or kidney transplant recipients.

The researchers found that patients who were receiving a PI had higher rates of hyperlipidemia, diabetes mellitus, and coronary artery disease.

The SWORD 1 and SWORD 2 trials enrolled 1027 HIV-infected and virologically suppressed adults; both trials had an early (Day 1 to Week 52) and late (Week 52 to Week 148) switch phase.

Findings from the study were presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam.

In the new subgroup analysis, these results were found to be consistent regardless of baseline regimen.

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 regimens were well-tolerated as evident by the comparable incidence of local and systemic reactions among all treatment arms. No grade 4 adverse events or death were reported.

Vemlidy, a nucleoside analogue (reverse transcriptase inhibitor), is currently approved to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

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 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 approval of Trogarzo was supported by a clinical trial (N=40) of heavily treatment-experienced adults with multidrug resistant HIV-1 infection who continued to have high levels of HIV RNA in their blood despite antiretroviral therapy.

Symfi contains the same triple combination ingredients found in the recently approved and launched Symfi Lo but with a 600mg dose of efavirenz vs 400mg seen in Symfi Lo.

Among respondents to the female survey, the burden scores were higher in women reporting amenorrhea due to natural menopause or hysterectomy (104 respondents) versus the menstruating group (118 respondents) for muscle aches/pains (P=0.05), fatigue (P=0.03), and difficulty falling asleep (P=0.04), independent of age, HIV duration, and number of HIV-associated, non-AIDS conditions.

The Isentress (raltegravir) and Isentrress (raltegravir) HD label was recently updated to include Week 96 data from the Phase 3 trial (ONCEMRK).

As of October 2017 — the cut off date for interim analysis — 89% of the rings returned had residual dapivirine levels consistent with some use in the prior month.

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 is indicated as a complete regimen for the treatment of HIV-1 in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50c/mL) on a stable antiretroviral regimen for at least 3 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

Symfi Lo will be available in the coming weeks whereas Cimduo is expected in the second quarter of 2018.

The study had to be cut short when 2 of 4 subjects developed serious toxicities following the third isoniazid-rifapentine dose.

Biktarvy combines bictegravir, an integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), two nucleoside reverse transcriptase inhibitors (NRTIs).

Symfi Lo combines efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors.

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.