The EMERALD Study is a Phase III, open-label, noninferiority study in which 1,141 patients with stable HIV suppression on a regimen comprising a boosted protease inhibitor plus TDF/FTC were randomized (2:1) to either switch to an investigational single-tablet regimen containing...

Treatment of tuberculosis (TB) in HIV-infected persons remains challenging, in part because of drug interactions between rifampin and some ARVs that may compromise antiretroviral therapy (ART). Three studies presented at CROI provide clinicians with additional guidance on how to manage certain...

Bictegravir (BIC), a new integrase inhibitor, was recently approved by the FDA for use in a single-pill coformulation with TAF/FTC (brand name: Biktarvy) as initial therapy and as a switch regimen for patients who are already on a suppressive ART regimen and who have no history of...

The availability of ART immediately after the diagnosis of HIV offers many possible benefits, including earlier engagement in care and earlier HIV suppression, which may result in personal and public health benefits. Based on randomized clinical trials done in developing-world...

Doravirine (DOR) is an investigational NNRTI that currently is being developed in a coformulation with TDF and FTC. A Phase 3 comparison of DOR + 2 NRTIs (87% of study subjects were given TDF/FTC) and DRV/r + 2 NRTIs in initial therapy was presented at CROI earlier this year (...

The EMERALD Study is a Phase 3 randomized (2:1), open-label, noninferiority study examining the strategy of switching patients with suppressed HIV RNA on a regimen consisting of a boosted protease inhibitor plus tenofovir disoproxil fumarate (TDF)/emtricitabine to an...

Bictegravir is an investigational integrase inhibitor that is dosed once daily, unboosted. It is active in vitro against many viruses with integrase resistance mutations. A Phase 2 double-blind placebo-controlled study randomized treatment-naive patients (n...

Leading up to this year, some researchers and clinicians had optimistically viewed dolutegravir an invincible ARV, a drug so mighty that it was unlikely to fail, and even more unlikely to be victim to emergent resistance mutations. Two presentations at CROI demonstrated the...

At the ASM Microbe meeting in June, researchers from Gilead Sciences presented data on use of TDF/FTC (Truvada) PrEP in the United States according to sex and race. They evaluated national pharmacy databases to identify prescriptions of TDF/FTC given for PrEP between January 2012 and September...

The PARTNER Study, a multisite European study, evaluated rates of HIV transmissions within serodifferent heterosexual and MSM couples (n = 548 and n = 340, respectively, contributed eligible data). The HIV-positive partners were on ART with HIV RNA levels of <200 copies/mL, and the couples...

Using data from the Medical Monitoring Project, this article presents a useful view of ARV treatment in the United States. The analysis demonstrates that U.S. national rates of both ARV prescribing (for persons maintained in care) and viral suppression to <200 copies/mL increased from...

Tenofovir disoproxil fumarate (TDF) may cause decreases in bone mineral density (BMD) both in HIV-infected patients treated with TDF-containing ARV regimens and in HIV-uninfected persons who use it for PrEP. A substudy of the large iPrEx trial of TDF/FTC PrEP in MSM and transgender...

The FDA has approved a new 2-NRTI formulation containing tenofovir alafenamide (TAF) 25 mg + emtricitabine (FTC) 200 mg for adults and children ≥12 years of age; its brand name is Descovy. This is a TAF-containing alternative to TDF/FTC (Truvada).

Recommended dosing is 1 tablet PO daily...

Researchers at the 2016 Conference on Retroviruses and Opportunistic Infections presented results from a randomized double-blind, double-dummy switch study of TAF/FTC. Over 660 patients with virologic suppression on TDF/FTC-containing 3-drug regimens were either switched to TAF/FTC (200/10 mg...

A pharmacokinetic study presented at the Conference on Retroviruses and Opportunistic Infections in Boston in February evaluated concentrations of tenofovir (TFV) and TFV-diphosphate (DP) in genital and rectal tissue and in anogenital fluid samples after administration of oral tenofovir...

The U.S. Food and Drug Administration has approved rilpivirine for use in adolescents 12 to 18 years of age; it is not recommended for younger children. As in adults, it is suggested for use in ARV-naive individuals with HIV RNA levels of ≤100,000 copies/mL. The dosage is 25 mg...

Pyrimethamine is no longer available in retail pharmacies in the United States, though it is available through a commercial specialty pharmacy program (the application process, approval, and delivery of the medication will take at least 2 days; for information on ordering, click...

Annual meetings of the Centers for Disease Control and Prevention (CDC)-sponsored Elimination of Mother-to-Child Transmission of HIV (EMCT) Stakeholders Group and the Expert Panel on Reproductive Health and Preconception Care for Persons Living with HIV, held at the Washington...

Very few data are available to gauge the possible benefits and adverse effects of long-term testosterone supplementation in HIV-infected men. Despite this, and despite concerns about possible risks of testosterone supplementation (eg, cardiovascular events, prostate cancer), testosterone...

Two boosted protease inhibitor (PI) coformulations have just been approved by the FDA. These are:

In these fixed-dose combinations, cobicistat is used as the pharmacokinetic booster of the PI...

Providers at Kaiser San Francisco, which has a large HIV preexposure prophylaxis (PrEP) program, recently published a brief report on 2 patients who developed acute HCV while on HIV PrEP. This reinforces what we might expect--that while PrEP may be effective as an HIV prevention method,...

Are you still conflicted about the choice between the NRTI backbones abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC)? A recent report will give you more to consider. It has been observed in other studies that patients on TDF/FTC tended to have lower lipid values than those on...

Two boosted protease inhibitor (PI) coformulations have just been approved by the FDA. These are:

In these fixed-dose combinations, cobicistat is used as the pharmacokinetic booster of the PI...

Elvitegravir is an HIV integrase inhibitor that requires pharmacokinetic enhancement with cobicistat or ritonavir. Since 2012 it has been available in a coformulation with cobicistat, tenofovir, and emtricitabine (Stribild) for treatment-naïve adults. This month the FDA approved elvitegravir as...

The FDA has approved the coformulation of the integrase inhibitor dolutegravir (50 mg) with the NRTIs abacavir (600 mg) and lamivudine (300 mg); its brand name is Triumeq. Triumeq is the first single-pill combination that does not include tenofovir.

Dosing is...

Antacids, laxatives, mineral supplements, and other compounds that contain metal cations (eg, calcium, magnesium, aluminum, and iron) may decrease levels of integrase inhibitors if taken close in time to each other. Results of two studies help to assess the magnitude of this effect and assist in...

Over the past few years, numerous studies have examined the use of NRTI-sparing regimens in initial therapy. These regimens generally have not been as effective as standard regimens, for reasons that are not entirely clear, or have had higher rates of toxicity. Two small studies...

This month the AETC NRC is reaching a milestone in a year-long process to update and upgrade our website. If you are reading this blog post, you are one of our new website's visitors. The biggest changes may be behind the scenes -- we moved all of our content into a new content management system...

Dolutegravir (DTG), the third integrase inhibitor approved by the FDA, previously has been compared with raltegravir and with efavirenz in antiretroviral-naive patients. At ICAAC, data from an ongoing open-label comparison of DTG with ritonavir-boosted darunavir (DRV/r) were...

The integrase inhibitor dolutegravir (brand name: Tivicay) was approved by the U.S. Federal Drug Administration in August, for use in treatment-naive and treatment-experienced adults, as well as for children aged ≥12 years (and weight ≥40 kg) who have not previously taken integrase inhibitors....

Program Manager AETC National Resource Center

As leaders in HIV education, prevention and reform, the AIDS Education and Training Center (AETC) network has remained committed to closing the gap of HIV racial health inequities.  Despite these efforts, HIV/AIDS continues...

Boceprevir (BOC) is a hepatitis C virus (HCV) NS3/4A protease inhibitor used in combination with pegylated interferon + ribavirin for the treatment of HCV. As BOC is an inhibitor of hepatic cytochrome (CYP) 3A4, and many protease inhibitors and NNRTIs affect or are...

The FDA recently approved revisions to the pediatric dosing recommendations for darunavir tablets and oral suspension. Once-daily dosing of darunavir + ritonavir is recommended for children 3 years of age and older, and >10 kg in weight, who are treatment naive or whose HIV virus does not...

You’re planning a training for oral health providers at varying clinics at a designated time. You know you’ll need to use some kind of technology to reach your target audience, but what type(s) of technology should you use and what are the adult learning best practices that apply?  How will you...

Elvitegravir is a once-daily integrase inhibitor that requires PK boosting with either ritonavir or cobicistat. It recently received FDA approval for initial therapy as part of a fixed-dose combination that includes cobicistat, tenofovir, and emtricitabine (Stribild).

Dolutegravir (formerly known as S/GSK 572) is an investigational integrase inhibitor that is in the late stages of development. It is administered once daily and does not require pharmacokinetic boosting. Two recently presented Phase 3 studies evaluated dolutegravir in combination...

Recommendations for coadministration of pravastatin with darunavir have been based on a small PK study that showed substantial intersubject variability in the impact of interactions between the two drugs.[1] In that study, concurrent administration of pravastatin (40 mg, single...

The AETC National Resource Center (NRC) wrapped up its Social Media Workgroup in November 2011 with a web-based debate entitled “To Tweet or Not to Tweet, That is the Question: AETCs and Social Media,”a tongue-in-cheeky, yet, comprehensive review on the pros and cons of social media and how the...

Recommendations for use of the recently approved NNRTI rilpivirine have been added to the U.S. Department of Health and Human Services adult and...

It has been reported previously that efavirenz reduces serum levels of rilpivirine and that this effect may be prolonged, even after discontinuation of efavirenz (see Sustained Effect of Efavirenz on Rilpivirine Serum Concentrations). A small, nonrandomized study was designed to answer the...