HIV/AIDS

FDA Approves Two New Oral Treatments for HIV-1 Infection

By August 31, 2018

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

1997 to 2015 Saw Increase in HIV Viral Suppression Rates

August 23, 2018

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

Long-Acting 2-Drug Injectable Noninferior to Oral 3-Drug Combo in HIV Study

By August 16, 2018

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

Labeling for Several HIV Meds Updated to Include Interaction Data With DOACs

By August 14, 2018

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

Mavyret Labeling Updated With Dosing for Liver, Kidney Transplant Patients

By August 10, 2018

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

Protease Inhibitors May Worsen Outcomes in Patients With HIV + Heart Failure

August 02, 2018

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

Juluca Maintains Viral Suppression in HIV Patients Through 100 Weeks

By July 25, 2018

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.

Increased Use of Truvada for PrEP Linked to Declines in New HIV Cases

By July 24, 2018

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

New Data Reinforce Efficacy of Symtuza for HIV-1 Treatment

By July 24, 2018

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

Single-Tablet Regimen Symtuza Approved to Treat HIV-1 Infection

By July 18, 2018

Symtuza is the first complete darunavir-based single-tablet regimen to be approved.

Intelence Indication Expanded to Include Younger HIV Patients

By July 18, 2018

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.

Novel Mosaic HIV Vaccine Safe, Immunogenic in Healthy Adults and Monkeys

By July 13, 2018

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.

Long-Term Safety Data for Vemlidy in Chronic Hepatitis B Added to Labeling

By July 05, 2018

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

Prezcobix Not Recommended During Pregnancy, According to Updated Labeling

By June 05, 2018

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.

FDA: Possible Risk of Neural Tube Birth Defects With Certain HIV Meds

By May 18, 2018

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.

Truvada Approved for HIV-1 Pre-Exposure Prophylaxis in At-Risk Adolescents

By May 17, 2018

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).

In-utero exposure to tenofovir-emtricitabine not associated with higher risk of adverse birth outcomes

May 01, 2018

Pairwise comparisons of tenofovir-emtricitabine and ritonavir-boosted lopinavir (TDF-FTC-LPV/r), zidovudine-lamivudine and ritonavir-boosted lopinavir (ZDV-3TC-LPV/r), and tenofovir-emtricitabine and ritonavir-boosted atazanavir (TDF-FTC-ATV/r) HIV regimens among pregnant women with HIV showed all three regimens had comparable risks of preterm birth, low birth weight, and neonatal death.

Novel Antiretroviral Therapy Trogarzo Now Available to Treat HIV-1

By April 30, 2018

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.

FDA Approves Combination Treatment Symfi for HIV-1 Infection

By March 28, 2018

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.

For Those With HIV, Symptom Burden Higher in Women

March 26, 2018

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.

Raltegravir Labeling Updated With Long-Term Data from Phase 3 HIV Trial

By March 09, 2018

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

High Adherence to HIV Preventative Vaginal Ring Seen in Study

By March 08, 2018

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.

Trogarzo Approved to Treat Multidrug Resistant HIV-1 Infection

By March 06, 2018

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 Found to Be Non-Inferior to Abacavir-Containing Regimen in Phase 3 Study

By March 05, 2018

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, Cimduo Will Be Available Soon for HIV Treatment

By March 02, 2018

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

Unexpected Toxicities Identified With Concomitant HIV, Tuberculosis Tx Use

By February 09, 2018

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

FDA Approves Biktarvy to Treat HIV-1 Infection in Adults

By February 08, 2018

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

Three-Drug Combo Symfi Lo Approved for the Treatment of HIV

By February 07, 2018

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.

Edurant Dosing Recommendations Updated for Pregnant HIV Patients

By February 02, 2018

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

Prezcobix Labeling Updated With New Drug Interactions

By January 31, 2018

Prezcobix, a combination of an HIV-1 protease inhibitor and a CYP3A inhibitor, is indicated to treat HIV-1 infection in adults.