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Tytuł:
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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.
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Autorzy:
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Santevecchi BA; University of Florida, Gainesville, FL, USA.
Miller S; University of Florida, Gainesville, FL, USA.
Childs-Kean LM; University of Florida, Gainesville, FL, USA.
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Źródło:
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The Annals of pharmacotherapy [Ann Pharmacother] 2020 Dec; Vol. 54 (12), pp. 1252-1259. Date of Electronic Publication: 2020 Jun 09.
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Typ publikacji:
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Journal Article; Review
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Język:
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English
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Imprint Name(s):
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Publication: Sept. 2013- : Thousand Oaks, CA : Sage
Original Publication: Cincinnati, OH : Harvey Whitney Books Co., c1992-
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MeSH Terms:
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Anti-HIV Agents/*therapeutic use
HIV Infections/*drug therapy
HIV-1/*drug effects
Heterocyclic Compounds, 3-Ring/*therapeutic use
Lamivudine/*therapeutic use
Oxazines/*therapeutic use
Piperazines/*therapeutic use
Pyridones/*therapeutic use
Adult ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/adverse effects ; Clinical Trials as Topic ; Drug Administration Schedule ; Drug Combinations ; Female ; Heterocyclic Compounds, 3-Ring/administration & dosage ; Heterocyclic Compounds, 3-Ring/adverse effects ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Male ; Mutation ; Oxazines/administration & dosage ; Oxazines/adverse effects ; Piperazines/administration & dosage ; Piperazines/adverse effects ; Pyridones/administration & dosage ; Pyridones/adverse effects ; Tablets ; Treatment Outcome
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Contributed Indexing:
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Keywords: HIV/AIDS; antiretrovirals; clinical trials; drug development and approval; infectious diseases
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Substance Nomenclature:
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0 (Anti-HIV Agents)
0 (Drug Combinations)
0 (Heterocyclic Compounds, 3-Ring)
0 (Oxazines)
0 (Piperazines)
0 (Pyridones)
0 (Tablets)
2T8Q726O95 (Lamivudine)
DKO1W9H7M1 (dolutegravir)
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Entry Date(s):
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Date Created: 20200611 Date Completed: 20201225 Latest Revision: 20201225
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Update Code:
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20240104
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DOI:
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10.1177/1060028020933772
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PMID:
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32517480
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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.