ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)–infected Participants With HIV-1 RNA <500000 Copies/mL
| Autor: | Amesika N. Nyaku, Edward P. Acosta, Andrei Stefanescu, David W. Haas, Roy M. Gulick, Catherine Godfrey, Paul E. Sax, Carole L. Wallis, Kimberly Y. Smith, Beverly Sha, Lu Zheng, Baiba Bezins, Babafemi Taiwo, Cornelius N Van Dam |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Microbiology (medical) medicine.medical_specialty Anti-HIV Agents Pyridones 030106 microbiology HIV Infections Pilot Projects Drug resistance Piperazines 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Oxazines medicine Humans 030212 general & internal medicine Adverse effect Articles and Commentaries business.industry Lamivudine Viral Load Resistance mutation Confidence interval CD4 Lymphocyte Count Clinical trial Infectious Diseases chemistry Dolutegravir HIV-1 RNA Viral Drug Therapy Combination Female business Heterocyclic Compounds 3-Ring Viral load medicine.drug |
| Zdroj: | Clinical Infectious Diseases. 66:1689-1697 |
| ISSN: | 1537-6591 1058-4838 |
| Popis: | BACKGROUND: Limited data exist on initial human immunodeficiency virus type 1 (HIV-1) treatment with dolutegravir plus lamivudine. METHODS: A5353 is a phase 2, single-arm, pilot study of once-daily dolutegravir (50 mg) plus lamivudine (300 mg) in treatment-naive participants with HIV-1 RNA ≥1000 and 400 copies/mL at week 16/20 or >200 copies/mL at or after week 24. Dolutegravir levels and drug resistance testing were performed at VF. RESULTS: One hundred and twenty participants (87% male, median age 30 years, 37 (31%) HIV-1 RNA >100000 copies/mL) initiated study treatment. Median entry HIV-1 RNA and CD4 count were 4.61 log(10) copies/mL and 387 cells/mm(3). Virologic efficacy at week 24 was 108/120 (90%, confidence interval [83%, 95%]), with comparable results in the >100000 copies/mL and ≤100000 copies/mL strata, that is, 89% (75%, 97%) and 90% (82%, 96%), respectively. Three participants with VF, had undetected plasma dolutegravir at ≥1 time points; the M184V and R263R/K mutations developed in 1 participant. Two participants experienced grade 3 possible/probable treatment-related adverse events; none discontinued treatment due to adverse events. CONCLUSIONS: Dolutegravir plus lamivudine demonstrated efficacy in individuals with pretreatment HIV-1 RNA up to 500000 copies/mL in this pilot trial, but a participant developed resistance mutations. CLINICAL TRIALS REGISTRATION: NCT02582684. |
| Databáze: | OpenAIRE |
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