Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads: TANDEM Study Subgroup Analyses
Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment u...
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| Vydáno v: | Infectious diseases and therapy Ročník 13; číslo 4; s. 875 - 889 |
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| Hlavní autoři: | , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Springer Healthcare
01.04.2024
Springer Springer Nature B.V Adis, Springer Healthcare |
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| ISSN: | 2193-8229, 2193-6382 |
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| Abstract | Introduction
Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (
n
= 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml;
n
= 16) from the TANDEM study.
Methods
TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive.
Results
Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9–1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000–250,000 copies/ml: 1.2 [0.8–1.8] years; > 250,000 copies/ml: 1.0 [0.7–1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup.
Conclusions
Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. |
|---|---|
| AbstractList | Abstract Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. Methods TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Results Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9–1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000–250,000 copies/ml: 1.2 [0.8–1.8] years; > 250,000 copies/ml: 1.0 [0.7–1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Conclusions Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. IntroductionDolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study.MethodsTANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive.ResultsAmong 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9–1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000–250,000 copies/ml: 1.2 [0.8–1.8] years; > 250,000 copies/ml: 1.0 [0.7–1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup.ConclusionsResults demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study.INTRODUCTIONDolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study.TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive.METHODSTANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive.Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup.RESULTSAmong 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup.Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads.CONCLUSIONSResults demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA [greater than or equal to] 100,000 copies/ml; n = 16) from the TANDEM study. TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged [greater than or equal to] 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had [greater than or equal to] 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 ( 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA [greater than or equal to] 100,000 copies/ml; n = 16) from the TANDEM study. Methods TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged [greater than or equal to] 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had [greater than or equal to] 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Results Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 ( 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Conclusions Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy ( n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. Methods TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Results Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9–1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000–250,000 copies/ml: 1.2 [0.8–1.8] years; > 250,000 copies/ml: 1.0 [0.7–1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Conclusions Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads. |
| Audience | Academic |
| Author | Benson, Paul Oglesby, Alan Harper, Gavin Patarroyo, Jimena Donovan, Cynthia Metzner, Aimee A. Wallis, Hannah Merrill, Deanna Brogan, Andrew P. Kuretski, Jennifer Mycock, Katie |
| Author_xml | – sequence: 1 givenname: Paul surname: Benson fullname: Benson, Paul organization: Be Well Medical Center – sequence: 2 givenname: Jennifer surname: Kuretski fullname: Kuretski, Jennifer organization: Midway Specialty Care Center – sequence: 3 givenname: Cynthia surname: Donovan fullname: Donovan, Cynthia organization: ViiV Healthcare – sequence: 4 givenname: Gavin surname: Harper fullname: Harper, Gavin organization: Adelphi Real World, Adelphi Mill – sequence: 5 givenname: Deanna surname: Merrill fullname: Merrill, Deanna organization: ViiV Healthcare – sequence: 6 givenname: Aimee A. orcidid: 0000-0002-2702-3865 surname: Metzner fullname: Metzner, Aimee A. email: aimee.a.metzner@viivhealthcare.com organization: ViiV Healthcare – sequence: 7 givenname: Katie surname: Mycock fullname: Mycock, Katie organization: Adelphi Real World, Adelphi Mill – sequence: 8 givenname: Hannah surname: Wallis fullname: Wallis, Hannah organization: Adelphi Real World, Adelphi Mill – sequence: 9 givenname: Andrew P. surname: Brogan fullname: Brogan, Andrew P. organization: ViiV Healthcare – sequence: 10 givenname: Jimena surname: Patarroyo fullname: Patarroyo, Jimena organization: ViiV Healthcare – sequence: 11 givenname: Alan surname: Oglesby fullname: Oglesby, Alan organization: ViiV Healthcare |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38570444$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1093_jac_dkae456 crossref_primary_10_1093_jac_dkaf345 |
| Cites_doi | 10.1093/cid/civ981 10.1007/s40121-024-00961-y 10.3390/v14030524 10.1016/j.jgar.2019.08.010 10.1097/QAD.0000000000002979 10.1097/QAI.0000000000003053 10.1097/QAI.0000000000002302 10.1097/QAD.0000000000003070 10.1093/ofid/ofad101 10.1097/QAD.0000000000001476 10.1016/S0140-6736(18)32462-0 10.1097/QAI.0000000000002275 10.18683/germs.2017.1115 |
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| Issue | 4 |
| Keywords | HIV-1 Lamivudine Viral load Test-and-treat Dolutegravir Real-world evidence |
| Language | English |
| License | 2024. The Author(s). Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. |
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| References | GirouardMPSaxPEParkerRAThe cost-effectiveness and budget impact of 2-drug dolutegravir-lamivudine regimens for the treatment of HIV infection in the United StatesClin Infect Dis2016627847911:CAS:528:DC%2BC1cXitVGrt7c%3D10.1093/cid/civ98126658053 Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv. Accessed December 18, 2023. Pulido F, López Bernaldo de Quirós JC, Górgolas M, et al. 96 Weeks effectiveness and tolerability of DTG + 3TC in naive patients: the REDOLA study. Presented at HIV Drug Therapy Glasgow 2022; October 23–26, 2022; Glasgow, Scotland. EronJHungC-CBarilJ-GBrief report: virologic response by baseline viral load with dolutegravir plus lamivudine vs dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysisJ Acquir Immune Defic Syndr20208460651:CAS:528:DC%2BB3cXmtl2lsr0%3D10.1097/QAI.000000000000230231977595 CentoVPernoCFTwo-drug regimens with dolutegravir plus rilpivirine or lamivudine in HIV-1 treatment-naive, virologically-suppressed patients: latest evidence from the literature on their efficacy and safetyJ Glob Antimicrob Resist20202022823710.1016/j.jgar.2019.08.01031446092 Hidalgo-TenorioCPasquauJVinuesaDDOLAVI real-life study of dolutegravir plus lamivudine in naive HIV-1 patients (48 weeks)Viruses2022145241:CAS:528:DC%2BB38XosVGmt78%3D10.3390/v14030524353369318951045 New York State Department of Health. The new standard: treatment initiation at time of HIV diagnosis. https://www.health.ny.gov/diseases/aids/providers/treatment/docs/faqs.pdf. New York State Department of Health. Accessed February 16, 2024. BackD2-Drug regimens in HIV treatment: pharmacological considerationsGerms2017711311410.18683/germs.2017.1115289327105601093 ZhaoFRaoMChenWDolutegravir plus lamivudine dual-drug regimen in treatment-naive HIV-1-infected patients with high-level viral load: preliminary data from the real worldJ Acquir Immune Defic Syndr202291S1S16S191:CAS:528:DC%2BB38XisVSgs7vI10.1097/QAI.000000000000305336094510 Florida Department of Health. HIV test and treat (T&T) and re-engage in care guidance. Florida Department of Health. https://www.floridahealth.gov/diseases-and-conditions/aids/clinical_resources/_documents/Test_and_Treat_Guidance.pdf. Accessed February 16, 2024. CahnPSierra MaderoJArribasJRDurable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trialsJ Acquir Immune Defic Syndr20208331031810.1097/QAI.000000000000227531834000 SchneiderSBlickGBurkeCTwo-drug regimens dolutegravir/lamivudine and dolutegravir/rilpivirine are effective with few discontinuations in US real-world settings: results from the TANDEM studyInfect Dis Ther202410.1007/s40121-024-00961-y38570443 CahnPSierra MaderoJArribasJRDolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trialsLancet20193931431551:CAS:528:DC%2BC1cXitFKjsLnK10.1016/S0140-6736(18)32462-030420123 CahnPSierra MaderoJArribasJRThree-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naive adults with HIV-1 infectionAIDS20223639481:CAS:528:DC%2BB3MXis1KmsrnJ10.1097/QAD.000000000000307034534138 RolleC-PBerheMSinghTDolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIVAIDS202135195719651:CAS:528:DC%2BB3MXhvFWrsL3F10.1097/QAD.000000000000297934115650 Dovato [prescribing information]. Durham, NC: ViiV Healthcare; 2023. Juluca [prescribing information]. Durham, NC: ViiV Healthcare; 2022. Biktarvy [prescribing information]. Foster City, CA: Gilead Sciences, Inc; 2022. RolleC-PBerheMSinghTSustained virologic suppression with dolutegravir/lamivudine in a test-and-treat setting through 48 weeksOpen Forum Infect Dis202310ofad10110.1093/ofid/ofad1013696895910034754 AETC National Coordinating Resource Center. Immediate ART initiation & restart: guide for clinicians. https://aidsetc.org/sites/default/files/media/document/2023-06/ncrc-rapid-art-full.pdf. AIDS Education & Training Center Program. Accessed February 16, 2024. KatlamaCGhosnJMurphyRLIndividualized antiretroviral therapeutic approaches: less can be moreAIDS2017311065107110.1097/QAD.000000000000147628358730 C-P Rolle (950_CR13) 2021; 35 C-P Rolle (950_CR14) 2023; 10 P Cahn (950_CR9) 2020; 83 F Zhao (950_CR21) 2022; 91 C Hidalgo-Tenorio (950_CR19) 2022; 14 950_CR20 P Cahn (950_CR8) 2019; 393 950_CR12 D Back (950_CR7) 2017; 7 950_CR16 950_CR17 950_CR18 950_CR1 J Eron (950_CR11) 2020; 84 V Cento (950_CR5) 2020; 20 P Cahn (950_CR10) 2022; 36 950_CR2 C Katlama (950_CR4) 2017; 31 950_CR3 MP Girouard (950_CR6) 2016; 62 S Schneider (950_CR15) 2024 |
| References_xml | – reference: New York State Department of Health. The new standard: treatment initiation at time of HIV diagnosis. https://www.health.ny.gov/diseases/aids/providers/treatment/docs/faqs.pdf. New York State Department of Health. Accessed February 16, 2024. – reference: Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv. Accessed December 18, 2023. – reference: Pulido F, López Bernaldo de Quirós JC, Górgolas M, et al. 96 Weeks effectiveness and tolerability of DTG + 3TC in naive patients: the REDOLA study. Presented at HIV Drug Therapy Glasgow 2022; October 23–26, 2022; Glasgow, Scotland. – reference: GirouardMPSaxPEParkerRAThe cost-effectiveness and budget impact of 2-drug dolutegravir-lamivudine regimens for the treatment of HIV infection in the United StatesClin Infect Dis2016627847911:CAS:528:DC%2BC1cXitVGrt7c%3D10.1093/cid/civ98126658053 – reference: CahnPSierra MaderoJArribasJRDurable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trialsJ Acquir Immune Defic Syndr20208331031810.1097/QAI.000000000000227531834000 – reference: Juluca [prescribing information]. Durham, NC: ViiV Healthcare; 2022. – reference: Biktarvy [prescribing information]. Foster City, CA: Gilead Sciences, Inc; 2022. – reference: Hidalgo-TenorioCPasquauJVinuesaDDOLAVI real-life study of dolutegravir plus lamivudine in naive HIV-1 patients (48 weeks)Viruses2022145241:CAS:528:DC%2BB38XosVGmt78%3D10.3390/v14030524353369318951045 – reference: KatlamaCGhosnJMurphyRLIndividualized antiretroviral therapeutic approaches: less can be moreAIDS2017311065107110.1097/QAD.000000000000147628358730 – reference: CahnPSierra MaderoJArribasJRDolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trialsLancet20193931431551:CAS:528:DC%2BC1cXitFKjsLnK10.1016/S0140-6736(18)32462-030420123 – reference: AETC National Coordinating Resource Center. Immediate ART initiation & restart: guide for clinicians. https://aidsetc.org/sites/default/files/media/document/2023-06/ncrc-rapid-art-full.pdf. AIDS Education & Training Center Program. Accessed February 16, 2024. – reference: Dovato [prescribing information]. Durham, NC: ViiV Healthcare; 2023. – reference: BackD2-Drug regimens in HIV treatment: pharmacological considerationsGerms2017711311410.18683/germs.2017.1115289327105601093 – reference: SchneiderSBlickGBurkeCTwo-drug regimens dolutegravir/lamivudine and dolutegravir/rilpivirine are effective with few discontinuations in US real-world settings: results from the TANDEM studyInfect Dis Ther202410.1007/s40121-024-00961-y38570443 – reference: Florida Department of Health. HIV test and treat (T&T) and re-engage in care guidance. Florida Department of Health. https://www.floridahealth.gov/diseases-and-conditions/aids/clinical_resources/_documents/Test_and_Treat_Guidance.pdf. Accessed February 16, 2024. – reference: CentoVPernoCFTwo-drug regimens with dolutegravir plus rilpivirine or lamivudine in HIV-1 treatment-naive, virologically-suppressed patients: latest evidence from the literature on their efficacy and safetyJ Glob Antimicrob Resist20202022823710.1016/j.jgar.2019.08.01031446092 – reference: EronJHungC-CBarilJ-GBrief report: virologic response by baseline viral load with dolutegravir plus lamivudine vs dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysisJ Acquir Immune Defic Syndr20208460651:CAS:528:DC%2BB3cXmtl2lsr0%3D10.1097/QAI.000000000000230231977595 – reference: CahnPSierra MaderoJArribasJRThree-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naive adults with HIV-1 infectionAIDS20223639481:CAS:528:DC%2BB3MXis1KmsrnJ10.1097/QAD.000000000000307034534138 – reference: RolleC-PBerheMSinghTDolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIVAIDS202135195719651:CAS:528:DC%2BB3MXhvFWrsL3F10.1097/QAD.000000000000297934115650 – reference: ZhaoFRaoMChenWDolutegravir plus lamivudine dual-drug regimen in treatment-naive HIV-1-infected patients with high-level viral load: preliminary data from the real worldJ Acquir Immune Defic Syndr202291S1S16S191:CAS:528:DC%2BB38XisVSgs7vI10.1097/QAI.000000000000305336094510 – reference: RolleC-PBerheMSinghTSustained virologic suppression with dolutegravir/lamivudine in a test-and-treat setting through 48 weeksOpen Forum Infect Dis202310ofad10110.1093/ofid/ofad1013696895910034754 – ident: 950_CR20 – volume: 62 start-page: 784 year: 2016 ident: 950_CR6 publication-title: Clin Infect Dis doi: 10.1093/cid/civ981 – year: 2024 ident: 950_CR15 publication-title: Infect Dis Ther doi: 10.1007/s40121-024-00961-y – volume: 14 start-page: 524 year: 2022 ident: 950_CR19 publication-title: Viruses doi: 10.3390/v14030524 – ident: 950_CR18 – ident: 950_CR16 – ident: 950_CR17 – volume: 20 start-page: 228 year: 2020 ident: 950_CR5 publication-title: J Glob Antimicrob Resist doi: 10.1016/j.jgar.2019.08.010 – volume: 35 start-page: 1957 year: 2021 ident: 950_CR13 publication-title: AIDS doi: 10.1097/QAD.0000000000002979 – volume: 91 start-page: S16 issue: S1 year: 2022 ident: 950_CR21 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0000000000003053 – volume: 84 start-page: 60 year: 2020 ident: 950_CR11 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0000000000002302 – volume: 36 start-page: 39 year: 2022 ident: 950_CR10 publication-title: AIDS doi: 10.1097/QAD.0000000000003070 – ident: 950_CR12 – volume: 10 start-page: ofad101 year: 2023 ident: 950_CR14 publication-title: Open Forum Infect Dis doi: 10.1093/ofid/ofad101 – volume: 31 start-page: 1065 year: 2017 ident: 950_CR4 publication-title: AIDS doi: 10.1097/QAD.0000000000001476 – volume: 393 start-page: 143 year: 2019 ident: 950_CR8 publication-title: Lancet doi: 10.1016/S0140-6736(18)32462-0 – volume: 83 start-page: 310 year: 2020 ident: 950_CR9 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0000000000002275 – ident: 950_CR1 – volume: 7 start-page: 113 year: 2017 ident: 950_CR7 publication-title: Germs doi: 10.18683/germs.2017.1115 – ident: 950_CR3 – ident: 950_CR2 |
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Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy... Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive... Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy... IntroductionDolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy... Abstract Introduction Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral... |
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| SubjectTerms | Analysis Antiretroviral agents Antiretroviral drugs Antiviral agents Art history Care and treatment Dolutegravir Drug approval Drug therapy Failure analysis FDA approval Highly active antiretroviral therapy HIV (Viruses) HIV testing HIV-1 Infectious Diseases Internal Medicine Lamivudine Medicine Medicine & Public Health Original Research Real-world evidence RNA Social service Test-and-treat Viral load |
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| Title | Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads: TANDEM Study Subgroup Analyses |
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