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  • Doravirine in Initial Therapy: DRIVE-AHEAD Study

    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 (...

  • Bictegravir in Initial Therapy

    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

    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...

  • Recap: 17th Ryan White HIV/AIDS Program Clinical Care Conference

    Highlights from Laura W. Cheever, MD, ScM, HRSA HIV/AIDS Bureau Associate Administrator and Conference Co-Chair

    The field of HIV/AIDS care and treatment continues to evolve rapidly. Groundbreaking developments in HIV research are regularly presented at international meetings and...

  • CROI 2017: Failure of Dolutegravir Monotherapy

    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: Improvements in ART and Viral Suppression Rates in the United States

    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...

  • HIV Meds Update - RAPID: Immediate ART Initiation

    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

    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

    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...

  • TAF/FTC Coformulation Approved

    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...

  • Efavirenz, Dolutegravir, and Darunavir: Pharmacokinetics during Pregnancy

    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

    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...

  • FDA Approves New TAF-Containing Analogue of Complera; Complera Approved for Pediatrics

    The FDA has approved a single-pill combination of rilpivirine + emtricitabine + tenofovir alafenamide (TAF); its brand name is Odefsey.

    It is intended for initial treatment of HIV-1-infected persons age 12 years and older whose pretreatment HIV RNA is ≤100,000 copies/mL, or as a substitute...

  • Tissue Levels of TAF: Too Low for PrEP?

    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...

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

    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...

  • Adult and Adolescent Guidelines: Major Changes

    The U.S. Department of Health and Human Services has released new treatment guidelines for adults and adolescents, and these contain some important changes. Key among these is a major shakeup in the "Recommended Regimen Options" for initial therapy. 

    Efavirenz/TDF/FTC (Atripla) has...
  • Once-Daily Dosing of Lamivudine and Abacavir for Pediatric Patients

    The U.S. Food and Drug Administration has approved once-daily dosing recommendations for lamivudine and abacavir for HIV-infected children. Previously, these NRTIs were approved only for twice-daily dosing in children. The dosing revisions apply to both the oral solution and the tablet...

  • Drug-Drug Interactions: Tenofovir with Boosted PI + Ledipasvir

    It has been reported that the hepatitis C combination medication ledipasvir/sofosbuvir (LDV/SOF, Harvoni), and in particular the ledipasvir component, may increase tenofovir levels in the body. It also is known from previous investigations that ritonavir-boosted protease inhibitors (PIs)...

  • HIV PrEP and Incident HCV Infection

    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,...

  • Switch to TDF/FTC from ABC/3TC Lowers Lipids

    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 New Boosted-PI Coformulations

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

    Darunavir 800 mg + cobicistat 150 mg (Prezcobix), andAtazanavir 300 mg + cobicistat 150 mg (Evotaz)

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

  • Two New Boosted-PI Coformulations

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

    Darunavir 800 mg + cobicistat 150 mg (Prezcobix), andAtazanavir 300 mg + cobicistat 150 mg (Evotaz)

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

  • Drug-Drug Interactions: Etravirine with Dolutegravir or Atazanavir

    New data show that etravirine (ETR) substantially lowers plasma concentrations of dolutegravir (DTG) (DTG Cmin decreased 88%, AUC decreased 71%). This effect is lessened by coadministration of ritonavir-boosted PIs: the combination of ETR + DTG + darunavir/...

  • Cobicistat approved as PK booster

    Cobicistat, a CYP3A inhibitor, has been approved by the FDA to be used as a pharmacokinetic booster for atazanavir and once-daily darunavir.  Thus, it can be used as an alternative to ritonavir in these combinations. It already is available as a PK enhancer of elvitegravir in the elvitegravir/...

  • New Fixed-Dose Combination Pill: Dolutegravir + Abacavir + Lamivudine

    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...

  • Elvitegravir Approved as an Independent Medication

    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...

  • HIV Meds Updates: Fast Takes - ATV & Rilpivirine / Rifabutin

    ATV pediatric powder formulation

    An oral powder formulation of atazanavir has been approved by the FDA for use in infants and children older than 3 months and weighing 10 to <25 kg. It must administered with ritonavir, and used in combination with other antiretrovirals. For infants, it may be...

  • Darunavir + Raltegravir without NRTIs: NEAT Study Results

    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...

  • First-Line Therapy: Raltegravir, Darunavir, or Atazanavir?

    ACTG 5257 is a randomized open-label comparison of 3 ARV regimens for initial therapy: atazanavir + ritonavir (ATV/r), darunavir + ritonavir (DRV/r), or raltegravir (RAL), each in combination with fixed-dose tenofovir/emtricitabine.

    The 3 treatment groups (...

  • Dolutegravir vs Darunavir/ritonavir: Open-Label Study in ARV-Naive Patients

    Coauthor: Susa Coffey, MD; Medical Editor, AETC National Resource Center

    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...

  • Cobicistat and Stribild Use in Patients with Renal Insufficiency

    Coauthor: 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 in patients with mild-to-moderate renal...

  • Dolutegravir Receives FDA Approval

    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....

  • Dolutegravir More Effective Than Raltegravir in Treatment-Experienced Patients

    The investigational integrase inhibitor dolutegravir has been studied in treatment-naive patients and in treatment-experienced patients with integrase inhibitor-associated resistance. The present study (SAILING) evaluates dolutegravir in 715 patients who had resistance to at least...

  • Comparison of 2 Tenofovir Prodrugs: TAF (GS 7340) and TDF

    Tenofovir alafenamide fumarate (TAF) is an investigational prodrug of tenofovir. You will recall that the current tenofovir product, tenofovir disoproxil fumarate (TDF), also is a prodrug; so why are we interested in a new prodrug? This largely has to do with efforts to decrease...

  • Fast Takes: Darunavir Once-Daily Dosing for Children

    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...

  • Dolutegravir in Initial Therapy: Two Phase 3 Studies

    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...

  • Cobicistat as a PK Booster of Atazanavir

    Cobicistat is a derivative of ritonavir and a potent inhibitor of CYP3A. As does ritonavir, it "boosts" blood levels of other substrates of this enzyme but, unlike ritonavir, it has no activity against HIV. It has been developed as a pharmacokinetic enhancer of the integrase...

  • Elvitegravir as Effective as Raltegravir in Treatment-Experienced Patients

    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).

    ...
  • Darunavir + Raltegravir without NRTIs, revisited

    In early 2011, a single-arm study of the NRTI-sparing regimen of darunavir/ritonavir (800/100 mg QD) plus raltegravir (400 mg BID) reported worrisome rates of virologic failure, particularly among subjects with baseline HIV RNA levels of >100,000 copies/mL.(1) At ICAAC, researchers involved...

  • Once-Daily Etravirine

    The NNRTI etravirine is approved for twice-daily dosing in both treatment-naive and treatment-experienced patients. The pharmacokinetic characteristics of etravirine suggest it may be given once daily, and several recent trials have examined the efficacy of QD etravirine.

    In particular,...

  • Switching from Efavirenz to Rilpivirine

    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...

  • Winter 2011-12: ARV Fast Takes

    Rilpivirine Added to DHHS RecommendationsRaltegravir-Associated Skin ReactionsDarunavir Oral Suspension

    Rilpivirine Added to DHHS Recommendations

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

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