Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naive HIV-infected individuals in three randomized trials

AIDS

Volumn 29, Issue 2, 2015, Pages 167-174

  Raffi, Franҫois ^a   Rachlis, Anita ^b   Brinson, Cynthia ^c   Arasteh, Keikawus ^d   Górgolas, Miguel ^e   Brennan, Clare ^f   Pappa, Keith ^f   Almond, Steve ^g   Granier, Catherine ^h   Nichols, W Garrett ^f   Cuffe, Robert Liam ⁱ   Eron, Joseph ^j   Walmsley, Sharon ^k  

^a UNIVERSITÉ DE NANTES   (France)

^b UNIVERSITY OF TORONTO   (Canada)

^c Central Texas Clinical Research   (United States)

^d Vivantes Auguste Viktoria Klinikum   (Germany)

^e UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

^f GLAXOSMITHKLINE   (United States)

^g GLAXOSMITHKLINE   (Canada)

^h GLAXOSMITHKLINE   (United Kingdom)

ⁱ VIIV HEALTHCARE   (United States)

^j UNIVERSITY OF NORTH CAROLINA   (United States)

^k UNIVERSITY HEALTH NETWORK   (Canada)

more..

Author keywords

Dolutegravir; Integrase; Subgroup; Treatment efficacy; Treatment naive

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; DARUNAVIR PLUS RITONAVIR; DOLUTEGRAVIR; EFAVIRENZ; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; RALTEGRAVIR; 2 PYRROLIDONE DERIVATIVE; 2',3' DIDEOXYNUCLEOSIDE DERIVATIVE; ABACAVIR, LAMIVUDINE DRUG COMBINATION; ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DEOXYCYTIDINE; DRUG COMBINATION; EMTRICITABINE; FUSED HETEROCYCLIC RINGS; HUMAN IMMUNODEFICIENCY VIRUS PROTEINASE INHIBITOR; INTEGRASE INHIBITOR; LAMIVUDINE; PHOSPHONIC ACID DERIVATIVE; RITONAVIR; TENOFOVIR;

ADULT; ARTICLE; CD4 LYMPHOCYTE COUNT; COMPARATIVE STUDY; CONTROLLED STUDY; DEMOGRAPHY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; EXPLORATORY RESEARCH; FEMALE; HEPATITIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; TREATMENT OUTCOME; TREATMENT RESPONSE; VIRUS LOAD; ANALOGS AND DERIVATIVES; DRUG COMBINATION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; PHASE 3 CLINICAL TRIAL (TOPIC); PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGRESSION ANALYSIS;

ADENINE; ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; CLINICAL TRIALS, PHASE III AS TOPIC; COINFECTION; DEOXYCYTIDINE; DIDEOXYNUCLEOSIDES; DRUG COMBINATIONS; EMTRICITABINE; FEMALE; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; MALE; ORGANOPHOSPHONATES; PYRROLIDINONES; RALTEGRAVIR POTASSIUM; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGRESSION ANALYSIS; RETROSPECTIVE STUDIES; RITONAVIR; TENOFOVIR; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84920262900     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000519     Document Type: Article

References (14)

1. US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. Recommendation on integrase inhibitor use in antiretroviral treatment-naive HIV-infected individuals. http://aidsinfo.nih.gov/news/1392/hhs-panel-on-antiretroviral-guidelines-for-adults-and-adolescents-updates-recommendations-on-preferred-insti-based-regimens-for-art-naive-individuals. [Accessed 16 December 2013]
2. Branas F, Berenguer J, Sanchez-Conde M, Lopez-Bernaldo de Quiros JC, Miralles P, Cosin J, et al. The eldest of older adults living with HIV: response and adherence to highly active antiretroviral therapy. Am J Med 2008; 121:820-824.
3. Kumar PN, Rodriguez-French A, Thompson MA, Tashima KT, Averitt D, Wannamaker PG, et al. A prospective, 96-week study of the impact of Trizivir®, Combivir1®/nelfinavir and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med 2006; 7:85-98.
4. Tedaldi EM, Absalon J, Thomas AJ, Shlay JC, van den Berg-Wolf M. Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). J Acquir Immune Defic Syndr 2008; 47:441-448.
5. Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, et al. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med 2012; 13:127-131.
6. Raffi F, Rachlis A, Stellbrink H-J, Hardy WD, Torti C, Orkin C, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, noninferiority SPRING-2 study. Lancet 2013; 381:735-743.
7. Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med 2013; 369:1807-1818.
8. Clotet B, Feinberg J, van Lunzen J, Khuong-Josses M-A, Antinori A, Dumitru I, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised openlabel phase 3b study. Lancet 2014; 383:2222-2231.
9. Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, doubleblind, noninferiority trial. Lancet Infect Dis 2013; 13:927-935.
10. US Department of Health and Human Services. Guidance for Industry. Human immunodeficiency virus-1 infection: developing antiretroviral drugs for treatment. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf. [Accessed 25 February 2014]
11. Therneau TM, Grambsch PM. Modeling survival data: extending the Cox model. New York: Springer; 2000.
12. Akaike H. Information theory and an extension of the maximum likelihood principle. In: Petrov BN, Csaki F, editors. Second international symposium on information theory Budapest, Hungary: Akademiai Kiado; 1973. pp. 267-281.
13. Sax PE, Tierney C, Collier AC, Fischl MA, Mollan K, Peeples L, et al. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med 2009; 361:2230-2240.
14. Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS 2009; 23:1547-1556.