Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1

A clinical decision report using: Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34. https://doi.org/10.1016/S2352-3018(17)30179-0 for a patient with viriologically suppressed HIV-1.

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Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

AIDS Research and Human Retroviruses ◽

10.1089/aid.2019.0111 ◽

2020 ◽

Vol 36 (1) ◽

pp. 48-57 ◽

Cited By ~ 1

Author(s):

Erkki Lathouwers ◽

Eric Y Wong ◽

Kimberley Brown ◽

Bryan Baugh ◽

Anne Ghys ◽

...

Keyword(s):

Phase Iii ◽

Once Daily ◽

Single Tablet Regimen ◽

Tenofovir Alafenamide ◽

Living With Hiv ◽

Hiv 1

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Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study

HIV Research & Clinical Practice ◽

10.1080/15284336.2019.1608714 ◽

2019 ◽

Vol 20 (1) ◽

pp. 24-33

Author(s):

Bruce Rashbaum ◽

Christoph D. Spinner ◽

Cheryl McDonald ◽

Cristina Mussini ◽

John Jezorwski ◽

...

Keyword(s):

Phase 3 ◽

Subgroup Analyses ◽

Treatment Naïve ◽

Tenofovir Alafenamide ◽

Hiv 1

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Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study

AIDS Research and Therapy ◽

10.1186/s12981-019-0235-1 ◽

2019 ◽

Vol 16 (1) ◽

Cited By ~ 1

Author(s):

Gregory D. Huhn ◽

Joseph J. Eron ◽

Pierre-Marie Girard ◽

Chloe Orkin ◽

Jean-Michel Molina ◽

...

Keyword(s):

Phase 3 ◽

Subgroup Analyses ◽

Tenofovir Alafenamide ◽

Hiv 1

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A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection

Journal of Pharmacy Practice ◽

10.1177/0897190017710519 ◽

2017 ◽

Vol 31 (2) ◽

pp. 216-221 ◽

Cited By ~ 8

Author(s):

Sara A. Angione ◽

Sibyl M. Cherian ◽

Ayşe Elif Özdener

Keyword(s):

Bone Mineral Density ◽

Adverse Events ◽

Renal Impairment ◽

Bone Mineral ◽

Metabolic Effects ◽

Efficacy And Safety ◽

Mineral Density ◽

Single Tablet Regimen ◽

Tenofovir Alafenamide ◽

Hiv 1

Introduction: This review evaluates the efficacy and safety of Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [EVG/c/TAF/FTC]), a single-tablet regimen used for the management of HIV-1 infection. Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)–containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review. Methods: A MEDLINE with full text and PubMed literature search was conducted for the past 5 years, up to April 2016. Results: Virologic suppression was similar between the EVG/c/TAF/FTC and TDF-containing groups (<50 copies/mL) at week 48. The bone mineral density in the hip and spine showed a significant reduction in the TDF-containing groups. The glomerular filtration rate increased in patients in the EVG/c/TAF/FTC arm and there were significant differences in total proteinuria, albuminuria, and tubular proteinuria in patients switching to EVG/c/TAF/FTC. The most common adverse events were diarrhea, nausea, and headache. Discussion: The coformulated Genvoya regimen is well tolerated and effective in treatment-naive and virologically suppressed patients. Data seem to suggest it may also be effective and safe in patients with mild to moderate renal impairment. The lower-dosed single-tablet regimen has significantly reduced bone and renal side effects.

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Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study

The Lancet Infectious Diseases ◽

10.1016/s1473-3099(11)70249-3 ◽

2012 ◽

Vol 12 (1) ◽

pp. 27-35 ◽

Cited By ~ 129

Author(s):

Jean-Michel Molina ◽

Anthony LaMarca ◽

Jaime Andrade-Villanueva ◽

Bonaventura Clotet ◽

Nathan Clumeck ◽

...

Keyword(s):

Protease Inhibitor ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Once Daily ◽

Hiv 1

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Doing More With Less: Review of Dolutegravir-Lamivudine, a Novel Single-Tablet Regimen for Antiretroviral-Naïve Adults With HIV-1 Infection

Annals of Pharmacotherapy ◽

10.1177/1060028020933772 ◽

2020 ◽

Vol 54 (12) ◽

pp. 1252-1259

Author(s):

Barbara A. Santevecchi ◽

Stacy Miller ◽

Lindsey M. Childs-Kean

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Virological Suppression ◽

Phase Iii ◽

Efficacy And Safety ◽

Once Daily ◽

Review Articles ◽

Single Tablet Regimen ◽

Treatment Naïve ◽

Hiv 1

Objective: To review data on efficacy and safety of dolutegravir (DTG) and lamivudine (3TC) in treatment-naïve adults with HIV-1 infection. Data Sources: Phase III clinical trials and review articles were identified through PubMed (1996 to March 2020) and ClinicalTrials.gov (2000 to May 2020) using the keywords dolutegravir, lamivudine, and HIV. Study Selection and Data Extraction: Relevant clinical trials and review articles available in English evaluating efficacy and safety of DTG and 3TC were included. Data Synthesis: The once-daily, single-tablet regimen of DTG/3TC is the first dual antiretroviral therapy (ART) recommended for initial therapy in treatment-naïve adults with HIV-1 infection. DTG and 3TC were compared with a regimen of DTG and tenofovir disoproxil fumarate/emtricitabine in the GEMINI studies and demonstrated noninferiority for the primary end point of virological suppression at up to 96 weeks. No treatment-emergent resistance mutations were identified in a small group of participants who did not reach virological suppression. The regimen is well tolerated, and the most common adverse events reported in trials include headache, diarrhea, nausea, insomnia, and fatigue. Relevance to Patient Care and Clinical Practice: This dual-ART regimen is a favorable treatment option for ART-naïve patients with HIV-1 RNA <500 000 copies/mL, absence of hepatitis B virus, and no resistance to DTG or 3TC. Benefits of dual ART include reduction in treatment-related adverse events and toxicities, drug interactions, and cost. In addition, the once-daily, single-tablet formulation promotes adherence. Conclusions: DTG/3TC has demonstrated efficacy in maintaining virological suppression in ART-naïve patients at up to 96 weeks while minimizing treatment-related adverse events and toxicities.

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