Emerging antiretroviral drugs

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 2, 2014, Pages 211-219

  Fernández Montero, José Vicente ^a   Vispo, Eugenia ^a   Soriano, Vicente ^a  

^a HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

Author keywords

Antiretroviral therapy; Cobicistat; Dolutegravir; Elvitegravir; Human immunodeficiency virus; Single tablet regimens; Tenofovir

Indexed keywords

ANTIRETROVIRUS AGENT; CENICRIVIROC; CHEMOKINE RECEPTOR CCR5 ANTAGONIST; COBICISTAT; DOLUTEGRAVIR; INTEGRASE INHIBITOR; PRODRUG; TENOFOVIR ALAFENAMIDE;

DEVELOPMENTAL STAGE; DRUG POTENCY; DRUG TOLERABILITY; EVIDENCE BASED PRACTICE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICATION COMPLIANCE; PEER REVIEW; REVIEW; TABLET;

ANTI-HIV AGENTS; DRUG ADMINISTRATION SCHEDULE; DRUG APPROVAL; DRUG DESIGN; DRUG INTERACTIONS; DRUG RESISTANCE, VIRAL; HIV INFECTIONS; HUMANS; MEDICATION ADHERENCE;

EID: 84892184364     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.863277     Document Type: Review

References (54)

1. Palella F, Baker R, Moorman A, et al. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr 2006;43:27-34
2. De Clerq E. The history of antiretrovirals: key discoveries over the past 25 years. Rev Med Virol 2009;19:287-99
3. Rooke R, Tremblay M, Soudeyns H, et al. Isolation of drug-resistant variants of HIV-1 from patients on long-term zidovudine therapy. AIDS 1989;3:411-15
4. Chesney M. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis 2000;30(Suppl 2):171-6
5. Fernandez-Montero JV, Eugenia E, Barreiro P, et al. Antiretroviral drugrelated toxicities -clinical spectrum, prevention, and management. Expert Opin Drug Saf 2013;12:697-707
6. Llibre JM, Clotet B. Once-daily singletablet regimens: a long and winding road to excellence in antiretroviral treatment. AIDS Rev 2012;14:168-78
7. Rockstroh J, Lennox J, De Jesus E, et al. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive HIV-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis 2011;53:807-16
8. Eron J, Rockstroh J, Reynes J, et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, Phase III non-inferiority trial. Lancet Infect Dis 2011;11:907-15
9. Vispo E, Barreiro P, Maida I, et al. Simplification from protease inhibitors to once-or twice-daily raltegravir: the ODIS trial. HIV Clin Trials 2010;11:197-204
10. De Jesus E, Berger D, Markowitz M, et al. Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatmentexperienced patients. J Acquir Immune Defic Syndr 2006;43:1-5
11. Sax P, De Jesus E, Mills A, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, doubleblind, Phase III trial, analysis of results after 48 weeks. Lancet 2012;379:2439-48
12. Zolopa E, Sax P, De Jesus E, et al. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr 2013;63:96-100
13. Rockstroh J, De Jesus E, Henry K, et al. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavirboosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr 2013;62:483-6
14. Garrido C, Villacian J, Zahonero N, et al. Broad phenotypic cross-resistance to elvitegravir in HIV-infected patients failing on raltegravir-containing regimens. Antimicrob Agents Chemother 2012;56:2873-8
15. 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;54:254-8
16. 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;57:3536-46
17. Kobayashi M, Yoshinaga T, Seki T, et al. In vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor. Antimicrob Agents Chemother 2011;55:813-21
18. Garrido C, Soriano V, Geretti AM, et al. Resistance associated mutations to dolutegravir (S/GSK1349572) in HIVinfected patients -impact of HIV subtypes and prior raltegravir experience. Antiviral Res 2011;90:164-7
19. 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;27:1771-8
20. Walmsley S, Antela A, Clumeck N, et al. Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/ emtricitabine/efavirenz: 48-week results -SINGLE (ING114467) [abstract H-556b]. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2012); 9-12 September 2012; San Francisco, CA, USA
21. Feinberg J, Clotet B, Khuong M, et al. Once-daily dolutegravir is superior to darunavir/ritonavir in antiretroviral naive adults: 48-week results from FLAMINGO (ING114915) [abstract H-1464a]. 53rd ICAAC; 10-13 September 2013; Denver Colorado, USA
22. 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;381:735-43
23. Cahn P, Pozniak A, 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;382:700-8
24. Eron J, Clotet B, Durant J, et al. Safety and efficacy of dolutegravir in treatmentexperienced subjects with raltegravirresistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis 2013;207:740-8
25. Reese M, Savina P, Generaux G, 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;41:353-61
26. Koteff J, Borland J, Chen S, et al. A Phase I study to evaluate the effect of dolutegravir on renal function via measurement of iohexal and paraaminohippurate clearance in healthy subjects. Br J Clin Pharmacol 2013;75:990-6
27. Curtis L, Min S, Nichols G, et al. Once-daily dolutegravir (DTG; GSK1349572) has a renal safety profile comparable to raltegravir (RAL) and efavirenz in antiretroviral-naive adults: 48-week results from SPRING-2 (ING113086) and SINGLE (ING114467) [abstract TUPE282]. 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 30 June-3 July 2013; Kuala Lumpur, Malaysia
28. Thompson M, Aberg J, Hoy J, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. JAMA 2012;308:387-402
29. EACS. Management and treatment of HIV infection (v7.0, October 2012). Available from: www.europeanaidsclinicalsociety.org [Last accessed 28 October 2013]
30. DHHS. Panel on Antiretroviral Guidelines for Adults and Adolescents. 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 28 October 2013]
31. Hirnschall G, Harries A, Easterbrook P, et al. The next generation of the World Health Organizations global antiretroviral guidance. J Int AIDS Soc 2013;16:18757
32. Rodriguez-Novoa S, Alvarez E, Labarga P, et al. Renal toxicity associated with tenofovir use. Expert Opin Drug Saf 2010;9:545-59
33. Barrios A, Garc?a-Benayas T, Gonzalez-Lahoz J, Soriano V. Tenofovir-related nephrotoxicity in HIVinfected patients. AIDS 2004;18:960-3
34. Ruane P, De Jesus E, Berger D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. J Acquir Immune Defic Syndr 2013;63:449-55
35. Zolopa A, Ortiz R, Sax P, et al. Comparative study of tenofovir alafenamide vs tenofovir disoproxil fumarate, each with elvitegravir, cobicistat, and emtricitabine, for HIV treatment [abstract 99LB]. 20th Conference on Retroviruses and Opportunistic Infections; 3-6 March 2013; Atlanta, GA, USA
36. Demarest J, Amrine-Madsen H, Irlbeck D, et al. Virologic failure in firstline HIV therapy with a CCR5 entry inhibitor, aplaviroc, plus a fixed-dose combination of lamivudine-zidovudine: nucleoside reverse transcriptase inhibitor resistance regardless of envelope tropism. Antimicrob Agents Chemother 2009;53:1116-23
37. Caseiro M, Nelson M, Diaz R, et al. Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: final results of two randomized Phase III trials. J Infect 2012;65:326-35
38. Vispo E, Fernandez-Montero JV, Labarga P, et al. Low risk of liver toxicity using the most recently approved antiretroviral agents but still increased in HIV-hepatitis C virus coinfected patients. AIDS 2013;27:1187-8
39. Gathe J, Cade J, De Jesus E, et al. Week-24 primary analysis of cenicriviroc vs efavirenz, in combination with emtricitabine/tenofovir, in treatmentnaive HIV-1+ adults with CCR5-tropic virus [abstract 106LB]. 20th Conference on Retroviruses and Opportunistic Infections; 3-6 March 2013; Atlanta, GA, USA
40. Baba M, Takashima K, Miyake H, et al. TAK-652 inhibits CCR5-mediated HIV type 1 infection in vitro and has favorable pharmacokinetics in humans. Antimicrob Agents Chemother 2005;49:4584-91
41. Feinberg J, Thompson M, Cade J, et al. Final week 48 analysis of cenicriviroc compared to efavirenz in combination with emtricitabine/tenofovir in treatment-na?ve HIV-1-infected adults with CCR5-tropic virus [abstract PS4/1]. 14th EACS; 16-19 October 2013; Brussels, Belgium
42. Fernandez-Montero JV, Barreiro P, Soriano V. HIV protease inhibitors: recent clinical trials and recommendations on use. Expert Opin Pharmacother 2009;10:1615-29
43. Blanco F, San Roman J, Vispo E, et al. Management of metabolic complications and cardiovascular risk in HIV-infected patients. AIDS Rev 2010;12:231-41
44. Gallant J, Koenig E, Andrade-Villanueva J, et al. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis 2013;208:32-9
45. German P, Liu H, Szwarcberg J, et al. Effect of cobicistat on glomerular filtration rate in subjects with normal and impaired renal function. J Acquir Immune Defic Syndr 2012;61:32-40
46. Cohen C, Meyers J, Davis K. Association between daily antiretroviral pill burden and treatment adherence, hospitalisation risk, and other healthcare utilisation and costs in a US Medicaid population with HIV. BMJ Open 2013;3:e003028
47. Delfraissy JF, Flandre P, Delaugerre C, et al. Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS 2008;22:385-93
48. Pulido F, Arribas JR, Delgado R, et al. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS 2008;22:F1-9
49. Castagna A, Spagnuolo V, Galli L, et al. 48-weeks outcomes of atazanavir/ritonavir monotherapy as maintenance strategy in HIV-1 treated subjects with viral suppression: interim analysis results of the MODAT study [abstract PS4/2]. 14th EACS; 16-19 October 2013; Brussels, Belgium
50. Valantin M, Lambert-Niclot S, Flandre P, et al. Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study. J Antimicrob Chemother 2012;67:691-5
51. Mathis S, Khanlari B, Pulido F, et al. Effectiveness of protease inhibitor monotherapy versus combination antiretroviral maintenance therapy: a meta-Analysis. PLoS One 2011;6:e22003
52. Spreen W, Williams P, Margolis D, et al. First study of repeat dose coadministration of GSK1265744 and TMC278 long-Acting parenteral nanosuspensions: pharmacokinetics, safety, and tolerability in healthy adults [abstract WEAB0103]. 7th Annual IAS Conference on HIV Pathogenesis, Treatment and Prevention; 30 June -3 July, 2013; Kuala Lumpur, Malaysia
53. Cohen M, Chen Y, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Eng J Med 2011;365:493-505
54. Bor J, Herbst A, Newell M, Barnighausen T. Increases in adult life expectancy in rural South Africa: valuing the scale-up of HIV treatment. Science 2013;339:961-5