Dolutegravir for the treatment of adult patients with HIV-1 infection

Expert Review of Anti-Infective Therapy

Volumn 12, Issue 5, 2014, Pages 535-544

  Wu, Gary ^a   Abraham, Teena ^a   Saad, Nasser ^a  

^a NEW YORK METHODIST HOSPITAL   (United States)

Author keywords

antiretroviral; dolutegravir; HIV 1; human immunodeficiency virus; integrase inhibitors

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ANTICONVULSIVE AGENT; CREATININE; DARUNAVIR PLUS RITONAVIR; DOLUTEGRAVIR; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ELVITEGRAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ETRAVIRINE; FOSAMPRENAVIR PLUS RITONAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; NEVIRAPINE; PLACEBO; RALTEGRAVIR; RIFAMPICIN; RITONAVIR PLUS TIPRANAVIR; 2 PYRROLIDONE DERIVATIVE; 2',3' DIDEOXYNUCLEOSIDE DERIVATIVE; ABACAVIR, LAMIVUDINE DRUG COMBINATION; DRUG COMBINATION; FUSED HETEROCYCLIC RINGS; INTEGRASE; INTEGRASE INHIBITOR; LAMIVUDINE; QUINOLONE DERIVATIVE;

ABNORMAL DREAMING; ADULT; ANTIVIRAL ACTIVITY; ANTIVIRAL RESISTANCE; ANXIETY; AREA UNDER THE CURVE; ARTICLE; CD4 LYMPHOCYTE COUNT; CREATININE BLOOD LEVEL; DIARRHEA; DISTRIBUTION VOLUME; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG CEREBROSPINAL FLUID LEVEL; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG METABOLISM; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FOOD; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; NAUSEA; PHARMACODYNAMICS; PLASMA PROTEIN BINDING; RASH; RHINOPHARYNGITIS; SOMNOLENCE; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VIRUS LOAD; CLINICAL TRIAL (TOPIC); DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; DRUG INTERACTION; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; METABOLISM; PHYSIOLOGY; VIROLOGY;

ADULT; CLINICAL TRIALS AS TOPIC; DIDEOXYNUCLEOSIDES; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG INTERACTIONS; DRUG RESISTANCE, VIRAL; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INFECTIONS; HIV INTEGRASE; HIV INTEGRASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; PYRROLIDINONES; QUINOLONES;

EID: 84898993298     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/14787210.2014.907525     Document Type: Article

References (35)

1. World Health Organization. HIV/AIDS global situation and trends. Available from: www.who.int/gho/hiv/en/[Last accessed 20 October 2013]
2. Piot P, Quinn TC. Response to the AIDS pandemic - a global health model. N Engl J Med 2013;368(23):2210-18
3. UNAIDS 2013 AIDS by the numbers. Available from: www.unaids.org/en/media/ unaids/contentassets/documents/unaidspublication/2013/JC2571-AIDS-by-the- numbers-en.pdf [Last accessed 2 January 2014]
4. CDC basic statistics. Available from: www.cdc.gov/hiv/basics/statistics. html [Last accessed 20 January 2014]
5. Samji H, Cescon A, Hogg RS, et al. closing the gap increases the life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One 2013; 8(12):1-8
6. Karmon SL, Markowitz M. Next generation integrase inhibitors: where to after raltegravir Drugs 2013;73(3):213-18
7. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. Available from: http://aidsinfo. nih.gov/contentfiles/ lvguidelines/adultandadolescentgl.pdf [Last accessed 14 January 2014]
8. Recommendation on integrase inhibitor use in antiretroviral treatment-naive HIVinfected individuals from the HHS Panel on antiretroviral guidelines for adults and adolescents. Available from: http://aidsinfo. nih.gov/news/1392/hhs-panel-onantiretroviral- guidelines-for-adults- andadolescents- updates-recommendations-oninsti- based-regimens-for-art-naive- individuals [Last accessed 2 January 2014]
9. Isentress package insert, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. 2013
10. Stribild package insert, Gilead Sciences, Foster City, CA, USA. 2013
11. Tivicay package insert, GlaxoSmithKline, Research Triangle Park, NC, USA, 2013.
12. DeAnda F, Kendra L, Nolte RT, et al. Dolutegravir interactions with HIV-1 integrase-DNA: structural rationale for drug resistance and dissociation kinetics. PLoS ONE 2013;8(10)e77448
13. Hightower KE, Wang R, Deanda F, et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild-type and integrase inhibitor-resistant HIV- 1 integrase-DNA complexes. Antimicrob Agents Chemother 2011;55(10):4552-9
14. Song I, Borland J, Chen S, et al. Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir. Antimicrob Agents Chemother 2012;56(3):1627-9
15. Min S, Sloan L, Dejesus E, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1-infected adults. AIDS 2011;25(14):1737-45
16. Lunzen JV, Maggiolo F, Arribas JR, et al. Once daily dolutegravir (S/GSK1349572) in combinationtherapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis 2012;12(2):111-18
17. Stellbrink H, Reynes J, Lazzarin A, et al. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS 2013;27(11):1771-8
18. Raffi F, Rachlis A, Stellbrink H, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet 2013;13(11): 735-43
19. Raffi F, Jaeger H, Quiros-Roldan E, 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, double-blind,non- inferiority trial. Lancet Infect Dis 2013;13(11):927-35
20. Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med 2013;369(19):1807-18
21. Dolutegravir superior to darunavir at 48 weeks in open label ART-naive trial (The FLAMINGO study). Available from: www.natap.org/2013/ICAAC/ICAAC-24. htm [Last accessed 3 January 2014]
22. Dolutegravir Compared to Darunavir/Ritonavir, Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects (FLAMINGO). Available from: http://clinicaltrials.gov/ct2/show/NCT01449929 term=flamingo&rank=1 [Last accessed 2 January 2014]
23. Cahn P, Pozniak AL, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet 2013;382(9893):700-8
24. Enron JJ, Clotet B, Durant J, et al. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-Week Results of the VIKING Study. J Infect Dis 2013;207(5):740-8
25. Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis 2014. [Epub ahead of print]
26. Phase 3 Assessment of Dolutegravir (DTG) 50 mg Twice Daily (BID) in HIV-1-Infected Subjects With Raltegravir (RAL) and/or Elvitegravir (EVG) Resistance in VIKING-3: week 24 Results of All 183 Subjects Enrolled. Available from: www.natap.org/2013/IAS/IAS-21.htm [Last accessed 4 January 2014]
27. Reese MJ, Savina PM, Generaux GT, et al. In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, a HIV integrase inhibitor. Drug Metab Dispos 2013;41(2):353-61
28. Cottrell ML, Hadzic T, Kashuba L. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clin Pharmacokinet 2013;52(11):981-94
29. Ford SL, Gould E, Chen S, et al. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother 2013;57(11):5472-7
30. Song I, Mark S, Chen S, et al. Dolutegravir does not affect methadone pharmacokinetics in opioid-dependent, HIV-seronegative subjects. Drug Alcohol Depend 2013; 133(2):781-4
31. Song I, Borland J, Chen S, et al. Effects of etravirine alone and with ritonavir-boosted protease inhibitors on that pharmacokinetics of dolutegravir. Antimicrob Agents Chemother 2011;55(7):3517-21
32. Dooley KE, Sayre P, Borland J, et al. Safety, tolerability and pharmacokinetics of the HIV integrase inhibitor dolutegravir given twice daily with rifampin or once daily with rifabutin: results of a phase 1 study among healthy subjects. J Acquir Immune Defic Syndr 2013;62(1): 21-7
33. Schafer JJ, Squires KE. Integrase inhibitors: a novel class of antiretroviral agents. Ann Pharmacother 2010;44(1):145-56
34. Tivicay. Available from: www.viivhealthcare. com/our-medicines/tivicay. aspx [Last accessed 26 January 2014]
35. ViiV Requests FDA Approval for Dolutegravir Single-tablet Regimen for HIV. Available from: www.hivandhepatitis. com/hiv-treatment/experimental-hiv- drugs/4372-viiv-requests-fda-approval-fordolutegravir- single-tablet-regimen- for-hiv [Last accessed 4 January 2014]