Dolutegravir: First global approval

Drugs

Volumn 73, Issue 14, 2013, Pages 1627-1637

  Ballantyne, Anita D ^a   Perry, Caroline M ^b  

^a Adis   (New Zealand)

^b Uni Services House   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

DOLUTEGRAVIR;

ANTIVIRAL ACTIVITY; ARTICLE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INTERACTION; DRUG SAFETY; DRUG TOLERABILITY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MAXIMUM PLASMA CONCENTRATION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLACEBO EFFECT; PLASMA CONCENTRATION-TIME CURVE; UNSPECIFIED SIDE EFFECT; VIRUS RESISTANCE;

ANTI-RETROVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84892815609     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0121-4     Document Type: Article

References (62)

1. Messiaen P, Wensing AMJ, Fun A, et al. Clinical use of HIV integrase inhibitors: a systematic review and meta-analysis. PLoS ONE [Electronic Resource]. 2013;8(1):e52562
2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. http://aidsinfo. nih. gov/ContentFiles/AdultandAdolescentGL. pdf. Accessed 23 Aug 2013
3. Mesplede T, Quashie PK, Wainberg MA. Resistance to HIV integrase inhibitors. Curr Opin HIV AIDS. 2012;7(5):401-8
4. Abram ME, Hluhanich RM, Goodman DD, et al. Impact of primary elvitegravir resistance-associated mutations in HIV-1 integrase on drug susceptibility and viral replication fitness. Antimicrob Agents Chemother. 2013;57(6):2654-63
5. Powderly WG. Integrase inhibitors in the treatment of HIV-1 infection. J Antimicrob Chemother. 2010;65(12):2485-8
6. ViiV Healthcare. US prescribing information for Tivicay (dolutegravir). 2013. http://www. viivhealthcare. com/media/58599/us- tivicay. pdf. Accessed 23 Aug 2013
7. Eron 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
8. Williams I, Churchill D, Anderson J, et al. British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy. HIV Med. 2012;13(Suppl. 2):1-85
9. EACS European AIDS Clinical Society. Guidelines Version 6. 1. 2012. http://www. europeanaidsclinicalsociety. org/images/stories/ EACS-Pdf/EacsGuidelines-v6. 1-2edition. pdf. Accessed 10 Sep 2013
10. Wainberg MA, Mesplede T, Quashie PK. The development of novel HIV integrase inhibitors and the problem of drug resistance. Curr Opin Virol. 2012;2(5):656-62
11. Tang MW, Shafer RW. HIV-1 antiretroviral resistance: scientific principles and clinical applications. Drugs. 2012;72(9):e1-25
12. Geretti AM, Armenia D, Ceccherini-Silberstein F. Emerging patterns and implications of HIV-1 integrase inhibitor resistance. Curr Opin Infect Dis. 2012;25(6):677-86
13. Lenz JCC, Rockstroh JK. S/GSK1349572, a new integrase inhibitor for the treatment of HIV: promises and challenges. Expert Opin Investig Drugs. 2011;20(4):537-48
14. Karmon SL, Markowitz M. Next-generation integrase inhibitors: where to after raltegravir? Drugs. 2013;73(3):213-28
15. U. S. Food and Drug Administration. FDA approves new drug to treat HIV infection. http://www. fda. gov/NewsEvents/Newsroom/ PressAnnouncements/ ucm364744. htm. Accessed 23 Aug 2013
16. ViiV Healthcare. ViiV Healthcare announces regulatory submissions for dolutegravir in the EU, US and Canada. 2012. http:// www. viivhealthcare. com/media/press-releases/2012/december/ viiv-healthcare-announces-regulatory- submissions-for-dolutegravirin-the-eu-us-and-canada. aspx. Accessed 10 Sep 2013
17. ViiV Healthcare. ViiV Healthcare announces U. S. approval of Tivicay(Rm) (dolutegravir) for the treatment of HIV-1. 2013. http://www. viivhealthcare. com/media/press-releases/2013/august/ viiv-healthcare-announces-us-approval-of- tivicay%C2%AEdolutegravir-for-the-treatment-of-hiv-1. aspx. Accessed 10 Sep 2013
18. ViiV Healthcare Ltd. Shionogi and ViiV Healthcare announce new agreement to commercialise and develop integrase inhibitor portfolio. 2012. http://www. viivhealthcare. com/media/pressreleases/ 2012/october/shionogi-and-viiv- healthcare-announcenew-agreement-to-commercialise-and-develop-integrase- inhibitorportfolio. aspx. Accessed 10 Sep 2013
19. ViiV Healthcare. ViiV Healthcare launches: A new specialist HIV company dedicated to delivering advances in HIV treatment and care. 2009. http://www. viivhealthcare. com/media/press-releases/ 2012/october/shionogi-and-viiv- healthcare-announce-new-agreementto-commercialise-and-develop-integrase- inhibitor-portfolio. aspx. Accessed 10 Sep 2013
20. Sato A. In vitro passage of drug resistant HIV-1 against a next generation integrase inhibitor (INI), S/GSK1349572. In: 49th interscience conference on antimicrobial agents and chemotherapy. 2009:abstr. H-932
21. Underwood MR, Johns BA, Sato A, et al. The activity of the integrase inhibitor dolutegravir against HIV-1 variants isolated from raltegravir-treated adults. J Acquir Immune Defic Syndr. 2012;61(3):297-301
22. Seki T, Kobayashi M, Miki S, et al. High barrier to resistance for dolutegravir (DTG, S/GSK1349572) against raltegravir resistant Y143 mutants: An in vitro passage study. Antivir Ther. 2012;17: A62
23. Vavro C, Hasan S, Madsen H, et al. Prevalent polymorphisms in wild-type HIV-1 integrase are unlikely to engender drug resistance to dolutegravir (S/GSK1349572). Antimicrob Agents Chemother. 2013;57(3):1379-84
24. Kobayashi M, Seki T, Yoshinaga T, et al. Antiviral activity in vitro of the INI, dolutegravir, against raltegravir-resistant HIV-2 mutants [abstract no. 691]. In: 19th conference on retroviruses and opportunistic infections, Washington, DC, Mar 5-8 2012
25. Vavro CL, Dudas KC, Hasan S, et al. Dolutegravir treatment of HIV subjects with raltegravir resistance: integrase resistance evolution in cohort II of the VIKING study. Antivir Ther. 2012;17:A13
26. Stellbrink H-J, 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
27. ViiV Healthcare. Dolutegravir studies [ClinicalTrials. gov]. 2013. http://clinicaltrials. gov/ct2/results?term=dolutegravir&pg=2. Accessed 26 Aug 2013
28. GlaxoSmithKline. GSK1349572 studies [ClinicalTrials. gov]. 2013. http://clinicaltrials. gov/ct2/results?term=GSK1349572 &Search=Search. Accessed 26 Aug 2013
29. Greener BN, Adams J, Patterson K, et al. Single and multiple dose dolutegravir pharmacokinetics in the genital tract and colorectum of HIV-men and women [abstract no. 531]. In: 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, Mar 3-6 2013
30. Patel P, Song I, Borland J, et al. Pharmacokinetics of a dolutegravir pediatric granule formulation in healthy adult subjects [abstract no. 985]. In: 19th conference on retroviruses and opportunistic infections; 2012 Mar 5-8, Seattle, WA, 2012
31. Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1): 254-8
32. 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
33. Castellino S, Moss L, Wagner D, et al. Metabolism, excretion, and mass balance of the HIV-1 integrase inhibitor dolutegravir in humans. Antimicrob Agents Chemother. 2013;57(8):3536-46
34. 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
35. Song I, Min SS, Borland J, et al. The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants. J Clin Pharmacol. 2011;51(2):237-42
36. Song I, Borland J, Min S, et al. Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir. Antimicrob Agents Chemother. 2011;55(7): 3517-21
37. Song I, Borland J, Chen S, et al. Effect of atazanavir and atazanavir/ ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572. Br J Clin Pharmacol. 2011;72(1):103-8
38. Song I, Min SS, Borland J, et al. Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects. JAIDS. 2010;55(3):365-7
39. Patel P, Song I, Borland J, et al. Pharmacokinetics of the HIV integrase inhibitor S/GSK1349572 co-administered with acidreducing agents and multivitamins in healthy volunteers. J Antimicrob Chemother. 2011;66(7):1567-72
40. 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
41. Song I, Mark S, Borland J, et al. Dolutegravir has no effect on pharmacokinetics of methadone or oral contraceptives with norgestimate and ethinyl estradiol [abstract no. 535]. In: 20th Conference on Retroviruses and Opportunistic Infections; 2013 Mar 3-6; Atlanta, GA
42. Raffi F, Rachlis A, Stellbrink H-J, 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;381(9868): 735-43
43. Raffi F, Jaeger H, Motta D, et al. Dolutegravir is non-inferior to raltegravir and shows durable response through 96 weeks: results from the SPRING-2 trial [TULBPE17]. In: 7th International AIDS Society Conference on HIV Pathogenesis and Treatment; 2013 Jun 30-Jul 03, Kuala Lumpur
44. Walmsey S, Antela A, Clumeck N, et al. Dolutegravir abacavir/ lamivudine once daily statistically superior to tenofovir/ emtricitabine/efavirenz: 48-week results-SINGLE [abstract H-556b] [abstract no. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2012 Sept 9-12; San Francisco, CA
45. ViiV Healthcare. Dolutegravir compared to darunavir/ritonavir, each in combination with dual nucleoside reverse transcriptase inhibitors (NRTIs) in ART-naive subjects (FLAMINGO) [ClinicalTrials. gov identifier NCT01449929]. 2013. http:// clinicaltrials. gov/ct2/results?term=dolutegravir&pg=1. Accessed 26 Aug 2013
46. Cahn P, Pozniak AL, Mingrone H, et al. Dolutegravir (DTG) is superior to raltegravir (RAL) in ART-experienced, integrase naive subjects: week 48 results from SAILING (ING111762) [WELBB03]. In: 7th International AIDS Society Conference on HIV Pathogenesis and Treatment; 2013 Jun 30-Jul 03, Kuala Lumpur
47. Pozniak A, Mingrone H, Shuldyakov A, et al. Dolutegravir vs raltegravir in ART-experienced, integrase-naive subjects: 24-week interim results from SAILING (ING111762) [abstract no. 179LB]. In: 20th Conference on Retroviruses and Opportunistic Infections; 2013 Mar 3-6, Atlanta, GA
48. 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, doubleblind, non-inferiority SAILING study. Lancet. 2013;382(9893): 700-8
49. Cahn P, Pozniak AL, Shuldyakov A, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitornaive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. World Wide Web [online]. 2013 Jul 10
50. Nichols G, Mills A, Grossberg R, et al. Antiviral activity of dolutegravir in subjects with failure on an integrase inhibitorbased regimen: week 24 phase 3 results from VIKING-3 [abstract no. O232]. In: 11th International Congress on Drug Therapy in HIV Infection; 2012 Nov 11-15; Glasgow
51. Nichols G, Lazzrin A, Maggiolo F, et al. Phase 3 assessment of dolutegravir (DTG) 50 mg twice daily in HIV-1 infected subjects with raltegravir (RAL) and/or elvitegravir (EVG) resistence in VIKING-3: week 24 results of all 183 patients enrolled [abstract no. TULBPE19]. In: 7th International AIDS Society Conference on HIVPathogenesis, Treatment and Prevention; 2013 Jun 30-Jul 3; Kuala Lumpur
52. van Lunzen J, Maggiolo F, Arribas JR, et al. Once daily dolutegravir (S/GSK1349572) in combination therapy 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):111-8
53. 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
54. Eron Jr J, Rockstroh J, Pozniak A, et al. Dolutegravir treatment response by baseline viral load and NRTI backbone in treatmentnaive HIV-infected individuals [poster no. P204]. 11th International Congress on Drug Therapy in HIV Infection. JIAS. 2013; 15(Suppl. 4):18264
55. Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment-naive HIV individuals [abstract no. 554]. In: 20th Conference on Retroviruses and Opportunistic Infections; 2013 Mar 3-6; Atlanta (GA), Atlanta
56. Chen S, Min SS, Peppercorn A, et al. Effect of a single supratherapeutic dose of dolutegravir on cardiac repolarization. Pharmacother J Human Pharmacol Drug Ther. 2012;32(4):333-9
57. ViiV Healthcare. A trial comparing GSK1349572 50 mg plus abacavir/lamivudine once daily to Atripla (also called the SINGLE trial) [Clinicaltrials. gov identifier NCT01263015]. 2013. http://clinicaltrials. gov/ct2/results?term=dolutegravir&pg=1. Accessed 26 Aug 2013
58. Viiv Healthcare. Study assessing dolutegravir in HIV-1 infected subjects with virus resistant to raltegravir and/or elivitegravir (VIKING-4) [ClinicalTrials. gov identifier NCT01568892]. 2013. http://clinicaltrials. gov/ct2/results?term=dolutegravir&pg=1. Accessed 26 Aug 2013
59. ViiV Healthcare. A study to assess dolutegravir in HIV-infected subjects with treatment failure on an integrase inhibitor containing regimen (VIKING-3) [ClinicalTrials. gov identifier NCT01328041]. 2013. http://clinicaltrials. gov/ct2/results?term= dolutegravir&pg=1. Accessed 26 Aug 2013
60. ViiV Healthcare. A pilot study assessing the integrase inhibitor GSK1349572 in HIV-infected persons with virus resistant to raltegravir [ClinicalTrials. gov identifier NCT00950859]. 2013. http://clinicaltrials. gov/ct2/results?term=dolutegravir&pg=2. Accessed 26 Aug 2013
61. Viiv Healthcare. A study to determine safety and efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in human immunodeficiency virus (HIV)-1 infected antiretroviral therapy (ART) nave women (ARIA) [ClinicalTrials. gov identifier NCT01910402]. 2013. http://clinicaltrials. gov/ct2/results?term= dolutegravir&pg=1. Accessed 26 Aug 2013
62. ViiV Healthcare. Dolutegravir Expanded Access Study (DEAP) [ClinicalTrials. gov identifier NCT01536873]. 2013. http:// clinicaltrials. gov/ct2/results?term=dolutegravir&pg=1. Accessed 26 Aug 2013.