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Antiretroviral Therapy

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Active Resources: 51

Archive Resources: 20

Articles: 27

  • HIV Meds Updates - Long-acting Injectable Therapy: Cabotegravir + Rilpivirine

    Susa Coffey's picture

    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 (...

  • HIV Meds Updates - TANGO and SALSA Studies: Switch to DTG/3TC from 3-Drug ART

    Susa Coffey's picture

    TANGO is a randomized open-label study in which subjects with virologic suppression on standard 3-drug TAF-based ART either switched to the 2-drug regimen of dolutegravir (DTG)/lamivudine (3TC) (Dovato) n = 369) or continued their baseline ART (n = 372). Previously published...

  • HIV Meds Updates: Long-acting Injectable Therapy: Lenacapavir

    Susa Coffey's picture

    Lenacapavir (LEN) is a novel investigational long-acting injectable ARV that is administered every 6 months by subcutaneous (SC) injection. It is an HIV-1 capsid inhibitor that acts at several points in the HIV life cycle. As a novel class, has full activity against viruses with resistance to...

  • Long-acting Injectable PrEP: Cabotegravir

    Susa Coffey's picture

    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...

  • New ARV Approval - Fostemsavir

    Susa Coffey's picture

    In July 2020, the U.S. Food and Drug Administration approved fostemsavir (FTR) for treatment of people with multi-drug resistant HIV-1 whose current ARV regimen is failing because of resistance, intolerance, or safety issues. FTR is a novel attachment inhibitor that binds the HIV envelope...

  • Safety of Dolutegravir at Conception: Updated Data

    Susa Coffey's picture

    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...

  • FDA Approves 2-Drug Combination of Dolutegravir + Lamivudine

    Susa Coffey's picture

    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...

  • Tenofovir Alafenamide (TAF) and Darunavir/Cobicistat in Pregnant Women

    Jennifer Cocohoba's picture

    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...

  • U=U in PARTNER2 Study of MSM

    Susa Coffey's picture

    PARTNER1, whose results were reported last year,(1) was one of the studies that supported current efforts to promote the growing scientific consensus supporting "Treatment as Prevention" (TasP) or Undetectable = Untransmittable (U=U).

    PARTNER1 evaluated HIV transmission risk in a...

  • Darunavir/Cobicistat/FTC/TAF Coformulation Approved; More Data from EMERALD Switch Study

    Susa Coffey's picture

    The U.S. Food and Drug Administration has given approval to a coformulation of darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg, to be marketed under the brand name Symtuza. DRV/COBI/FTC/TAF constitutes a complete regimen for patients with susceptible HIV...

  • Bictegravir/TAF/FTC in Women

    Susa Coffey's picture

    The single-pill combination of bictegravir (BIC) with tenofovir alafenamide (TAF) and emtricitabine (FTC) has been shown in four Phase III trials to be effective as initial therapy.Also as a switch regimen in patients with stably suppressed HIV RNA and no resistance to BIC, TAF,...

  • Darunavir/Cobicistat/FTC/TAF Single-Pill Combination in Treatment-Experienced Patients: EMERALD Study

    Susa Coffey's picture

    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...

  • Rifampin Drug-Drug Interactions with Newer Antiretrovirals (TAF, Bictegravir, Dolutegravir)

    Jennifer Cocohoba's picture

    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 Approved for Initial ART, in Combination with TAF/FTC

    Susa Coffey's picture

    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...

  • Undetectable = Untransmittable: Effective HIV Treatment Prevents HIV Transmission

    Susa Coffey's picture

    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...

  • Doravirine in Initial Therapy: DRIVE-AHEAD Study

    Susa Coffey's picture

    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 (DRIVE-FORWARD); the...

  • Bictegravir in Initial Therapy

    Susa Coffey's picture

    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)...

  • On the Way: The First Protease Inhibitor-Based Single-Tablet Regimen

    Jennifer Cocohoba's picture

    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 investigational single-...

  • CROI 2017: Failure of Dolutegravir Monotherapy

    Susa Coffey's picture

    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...

  • HIV Meds Update - RAPID: Immediate ART Initiation

    Susa Coffey's picture

    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...

  • HIV Meds Update: Treatment as Prevention: Suppressive ART, Condomless Sex, and HIV Transmission Risk - also a Word on HPTN 052

    Susa Coffey's picture

    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...

  • HIV Meds Update: ART in Acute HIV--Decreasing HIV DNA

    Susa Coffey's picture

    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...

  • Efavirenz, Dolutegravir, and Darunavir: Pharmacokinetics during Pregnancy

    Jennifer Cocohoba's picture

    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...

  • Switching from TDF/FTC to TAF/FTC

    Susa Coffey's picture

    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...

  • Tissue Levels of TAF: Too Low for PrEP?

    Susa Coffey's picture

    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...

  • START-ing TEMPRANO: Early Initiation of Antiretroviral Therapy for HIV

    Jennifer Cocohoba's picture

    The prevailing opinion among experts regarding the optimal CD4 T-cell count at which to start patients on antiretroviral therapy (ART) has shifted several times during the evolution of HIV treatment. These shifts reflect attempts to strike a balance between preventing HIV-associated illness and...

  • Cobicistat and Stribild Use in Patients with Renal Insufficiency

    Ian R. McNicholl's picture

    Co-Author: Susa Coffey, MD; Medical Editor, AETC National Resource Center

    An open-label study is evaluating the renal safety of elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild, or the "quad" pill) and cobicistat. For those patients with mild-to-...