AETC National Coordinating Resource Center

The FLAIR study evaluated the efficacy and safety of the long-acting injectable regimen of cabotegravir (CAB) + rilpivirine (RPV) in previously ART-naïve individuals who switched to CAB+RPV after viral suppression on a standard 3-drug oral regimen (dolutegravir [DTG]/ABC/3TC). At both 48 weeks (...

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A long-acting formulation of the investigational integrase inhibitor cabotegravir (CAB) is being studied as a single agent for HIV prevention. (CAB also has been studied, in combination with long-acting rilpivirine, as treatment for people with HIV, see Long-Acting Injectable ART: Cabotegravir...

In 2018, initial results from the Tsepamo study of birth outcomes in Botswanan women treated with ART during pregnancy raised questions about the safety of dolutegravir (DTG) when given at the time of conception or very early in pregnancy. Specifically, an early interim analysis found a higher...

At CROI 2019, investigators presented 48-week results from the Phase 3 international multisite ATLAS and FLAIR studies of long-acting 2-drug injectable therapy. The study regimen consisted of the integrase inhibitor cabotegravir (CAB) plus the NNRTI rilpivirine (RPV), both given every 4 weeks as...

In April 2019, the U.S. Food and Drug Administration approved a combination pill comprising the integrase inhibitor dolutegravir (DTG), 50 mg, and the NRTI lamivudine (3TC), 300 mg, for use as a complete ARV regimen for initial HIV treatment of patients. The approval specifies that DTG/3TC is...

The U.S. Food and Drug Administration has approved the NNRTI doravirine for use in initial HIV therapy. FDA approval was based on 48-week results of 2 Phase III studies in treatment-naive persons that showed doravirine + 2 NRTIs resulted in similar rates of viral suppression at 48 weeks as...

Two pharmacokinetic studies from AIDS 2018 help elucidate the disposition of tenofovir alafenamide (TAF) and cobicistat-boosted darunavir during pregnancy.

The IMPAACT P1026s study examined plasma concentrations of TAF with and without cobicistat in 43 pregnant women. For women taking...

It's easier than ever to stay on target. The Health Resources and Services Administration's (HRSA) Ryan White HIV/AIDS Program (RWHAP) technical assistance (TA) and training website has undergone a major update to make it easier for users to access tools and materials for the RWHAP. The...

As we have commented in the past, initial ARV regimens consisting of 2 drugs tend to perform poorly in comparison with currently recommended 3-drug regimens. Yet, given toxicity concerns about some ARVs (particularly about tenofovir DF and abacavir) and cost concerns about 3-drug regimens, the...

On May 18, 2018, the U.S. Food and Drug Administration and the World Health Organization announced that cases of neural tube defects have been reported in babies of women with HIV who were on treatment with dolutegravir at the time of conception and during early pregnancy. The...

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...

Ibalizumab (TNX-355), an entry inhibitor, has been approved by the FDA for use in persons with an extensive ARV treatment history and multidrug resistant HIV who are on a failing ARV regimen. Ibalizumab (trade name: Trogarzo) is a monoclonal antibody that binds the CD4 receptor and blocks HIV...

In September 2017, the U.S. Centers for Disease Control and Prevention (CDC) officially recognized that suppressing HIV through antiretroviral therapy (ART) prevents sexual transmission of HIV. In a "Dear Colleague" letter, CDC officials said, "people who take ART daily as...

Bictegravir (BIC) is an investigational integrase inhibitor that is being studied as part of a coformulation with tenofovir alafenamide (TAF) and emtricitabine (FTC). Two Phase 3 trials comparing a single-tablet regimen of BIC/TAF/FTC (50/25/200 mg) with regimens containing dolutegravir (DTG)...

In recent years, a number of studies have evaluated 2-drug or even 1-drug ARV regimens, either in initial therapy or in switch regimens for patients with virologic suppression on 3-drug therapy. In general, these have not been as successful in achieving or maintaining virologic suppression as...

Doravirine is an investigational NNRTI that is active in vitro against many common NNRTI resistance mutations (including K103N, Y181C, and E138K). It is given once daily, has no food restrictions, and can be given with acid-blocking medications. In a Phase 2 study of treatment-...

We know that very early treatment in acute HIV infection decreases HIV RNA; this study shows it also greatly decreases proviral DNA (and reservoir size). Researchers investigated 2 small cohorts of patients in Thailand with acute (and very early) HIV infection, 1 untreated and 1 treated with ART...

This publication presents the results of San Francisco General Hospital's Ward 86 pilot study of immediate ART initiation. This RAPID program systematically offered ART to patients upon diagnosis of HIV; patients were referred from HIV testing sites in San Francisco. Of the 39 patients who...

Dolutegravir has several characteristics that, in theory, suggest it will not be significantly removed by dialysis: It has a large apparent volume of distribution (17.4 L) and is highly protein bound (98.9%). A small study of 5 HIV-infected patients with end-stage renal disease...

Three studies presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) explored the pharmacokinetics of antiretrovirals administered during pregnancy. These studies support the use of standard-dose efavirenz, once-daily dolutegravir, and BID ritonavir-boosted...

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