Has the time come to abandon efavirenz for first-line antiretroviral therapy?

Journal of Antimicrobial Chemotherapy

Volumn 69, Issue 7, 2014, Pages 1742-1747

  Raffi, Francois ^a   Pozniak, Anton L ^b   Wainberg, Mark A ^c  

^a NANTES UNIVERSITY HOSPITAL   (France)

^b CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^c MCGILL UNIVERSITY   (Canada)

Author keywords

Drug resistance; HIV clinical trials; HIV type 1; Neuropsychiatric adverse events; Non nucleoside reverse transcriptase inhibitors; Suicide

Indexed keywords

DOLUTEGRAVIR; EFAVIRENZ; RALTEGRAVIR; RILPIVIRINE; BENZOXAZINE DERIVATIVE;

ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; ARTICLE; DRUG EFFICACY; DRUG USE; EPIDEMIOLOGICAL DATA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MENTAL DISEASE; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); NEUROLOGIC DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; SUICIDAL BEHAVIOR; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HIV INFECTIONS; SUICIDE;

ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; BENZOXAZINES; DRUG RESISTANCE, VIRAL; HIV INFECTIONS; HUMANS; SUICIDE;

EID: 84902516981     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dku058     Document Type: Article

References (42)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. March 27, 2012 Update. http://aidsinfo.nih.gov/contentfiles/ AdultandAdolescentGL003093.pdf (16 January 2014, date last accessed).
2. Gulick RM, Ribaudo HJ, Shikuma CM et al. AIDS Clinical Trials Group (ACTG) A5095 Study Team. Three-vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial. JAMA 2006; 296: 769-81.
3. Cassetti I, Madruga JV, Suleiman JM et al. Study 903E Team. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients. HIV Clin Trials 2007; 8: 164-72.
4. Staszewski S, Morales-Ramirez J, Tashima KT et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. N Engl J Med 1999; 341: 1865-73.
5. Riddler SA, Haubrich R, DiRienzo AG et al. AIDS Clinical Trials Group Study A5142 Team. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008; 358: 2095-106.
6. Robbins GK, De Gruttola V, Shafer RWet al. AIDS Clinical Trials Group 384 Team. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med 2003; 349: 2293-303.
7. Gulick RM, Ribaudo HJ, Shikuma CM et al. AIDS Clinical Trials Group Study A5095 Team. Triple-nucleoside regimens versus efavirenz containing regimens for the initial treatment of HIV-1 infection. N Engl J Med 2004; 350: 1850-61.
8. van Leth F, Phanuphak P, Ruxrungtham K et al. 2NN Study Team. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363: 1253-63.
9. Molina JM, Cahn P, Grinsztejn B et al. ECHO Study Group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet 2011; 378: 238-46.
10. Cohen CJ, Andrade-Villanueva J, Clotet B et al. THRIVE Study Group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet 2011; 378: 229-37.
11. Daar ES, Tierney C, Fischl MA et al. AIDS Clinical Trials Group Study A5202 Team. Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med 2011; 154: 445-56.
12. Ministère des Affaires Sociales et de la Santé, Conseil National du Sida, Agence Nationale de Recherches sur le Sida et les Hépatites Virales. Prise en Charge Médicale des Personnes Vivant Avec le VIH, Recommandations du Groupe d'Experts, Rapport 2013. http://www.sante.gouv.fr/IMG/pdf/ Rapport_Morlat_2013_Mise_en_ligne.pdf (26 December 2013, date last accessed).
13. European AIDS Clinical Society. Guidelines, Version 7.0, October 2013. http://www.eacsociety.org/Portals/0/Guidelines_Online_131014.pdf (12 January 2014, date last accessed).
14. Williams I, Churchill D, Anderson J et al. BHIVA guidelines for the treatment of HIV-1 positive adults with antiretroviral therapy 2012. HIV Med 2012; 13 Suppl 2: 1-85.
15. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 12, 2013 Update. http://aidsinfo.nih.gov/ contentfiles/lvguidelines/adultandadolescentgl.pdf (12 January 2014, date last accessed).
16. WHO HIV/AIDS Programme. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. Summary of Key Features and Recommendations. June 2013. http://apps.who.int/iris/ bitstream/10665/85322/1/WHO_HIV_2013.7_eng.pdf (12 January 2014, date last accessed).
17. Ford N, Calmy A, Mofenson L. Safety of efavirenz in the first trimester of pregnancy: an updated systematic review and meta-analysis. AIDS 2011; 25: 2301-4.
18. Fundaro C, Genovese O, Rendeli C et al. Myelomeningocele in a child with intrauterine exposure to efavirenz. AIDS 2002; 16: 299-300.
19. Antiretroviral Pregnancy Registry Steering Committee. The Antiretroviral Pregnancy Registry Interim Report, 1 January 1989 Through 31 January 2013. http://www.apregistry.com/forms/interim_report.pdf (12 January 2014, date last accessed).
20. Sibiude J, Mandelbrot L, Blanche S et al. Birth defects and ART in the French perinatal cohort, a prospective exhaustive study among 13,124 live births from 1994 to 2010. In: Abstracts of the Twentieth Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, USA, 2013. Abstract 81. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
21. Hsu H, Rydzak C, Cotich KL et al. CEPAC Investigators. Quantifying the risks and benefits of efavirenz use in HIV-infected women of childbearing age in the USA. HIV Med 2011; 12: 97-108.
22. Nguyen A, Calmy A, Delhumeau C et al. A randomized cross-over study to compare raltegravir and efavirenz (SWITCH-ER study). AIDS 2001; 25: 1481-7.
23. Mollan K, Smurzynski M, Na L et al. Hazard of suicidality in patients randomly assigned to efavirenz for initial treatment of HIV-1: a cross-study analysis. In: Abstracts of IDWeek 2013, San Francisco, CA, USA, 2013. Abstract 670.
24. Winston A, Puls R, Kerr SJ et al. Dynamics of cognitive change in HIV-infected individuals commencing three different initial antiretroviral regimens: a randomized, controlled study. HIV Med 2012; 13: 245-51.
25. Walmsley SL, Antela A, Clumeck N et al. SINGLE Investigators. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection. N Engl J Med 2013; 369: 1807-18.
26. Rockstroh JK, DeJesus E, Lennox JL et al. STARTMRK Investigators. Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK. J Acquir Immune Defic Syndr 2013; 63: 77-85.
27. Cohen C, Wohl D, Arribas J et al. STaR study: single tablet regimen rilpivirine/emtricitabine/tenofovir DF maintains non-inferiority to efavirenz/emtricitabine/tenofovir DF in ART-naïve adults through week 96. In: Abstracts of the Fourteenth European AIDS Conference, Brussels, Belgium, 2013. Abstract LBPE7/17. European AIDS Clinical Society.
28. Cohen C, Wohl D, Arribas J et al. STaR study: single-tablet regimen emtricitabine/rilpivirine/tenofovir DF is non-inferior to efavirenz/ emtricitabine/tenofovir DF in ART-naïve adults. Week 48 results. In: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection, Glasgow, Scotland, 2012. Abstract O425.
29. Molina JM, Clumeck N, Redant K et al. Rilpivirine vs. efavirenz in HIV-1 patients with baseline viral load 100,000 copies/mL or less: week 48 phase III analysis. AIDS 2013; 27: 889-97.
30. Lennox JL, DeJesus E, Lazzarin A et al. STARTMRK Investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet 2009; 374: 796-806.
31. Cohen CJ, Molina JM, Cassetti I et al. ECHO and THRIVE Study Groups. Week 96 efficacy and safety of rilpivirine in treatment-naive, HIV-1 patients in two Phase III randomized trials. AIDS 2013; 27: 939-50.
32. Molina JM, Clumeck N, Orkin C et al. ECHO and THRIVE Study Groups. Week 96 analysis of rilpivirine or efavirenz in HIV-1-infected patients with baseline viral load ≤100000 copies/mL in the pooled ECHO and THRIVE phase 3, randomized, double-blind trials. HIV Med 2014; 15: 57-62.
33. Lennox JL, Dejesus E, Berger DS et al. STARTMRK Investigators. Raltegravir versus efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr 2010; 55: 39-48.
34. Wensing AM, van de Vijver DA, Angarano G et al. Prevalence of drug-resistant HIV-1 variants in untreated individuals in Europe: implications for clinical management. J Infect Dis 2005; 192: 958-66.
35. Kuritzkes DR, Lalama CM, Ribaudo HJ et al. Preexisting resistance to nonnucleoside reverse-transcriptase inhibitors predicts virologic failure of an efavirenz-based regimen in treatment-naive HIV-1-infected subjects. J Infect Dis 2008; 197: 867-70.
36. Geretti AM, Fox ZV, Booth CL et al. Low-frequency K103N strengthens the impact of transmitted drug resistance on virologic responses to first-line efavirenz or nevirapine-based highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2009; 52: 569-73.
37. Wittkop L, Günthard HF, deWolf F et al. EuroCoord-CHAIN Study Group. Effect of transmitted drug resistance on virological and immunological response to initial combination antiretroviral therapy for HIV (EuroCoord-CHAIN joint project): a European multicohort study. Lancet Infect Dis 2011; 11: 363-71.
38. Li JZ, Paredes R, Ribaudo HJ et al. Low-frequency HIV-1 drug resistance mutations and risk of NNRTI-based antiretroviral treatment failure: a systematic review and pooled analysis. JAMA 2011; 305: 1327-35.
39. Cozzi-Lepri A, Noguera-Julian M, Di Giallonardo F et al. Low-frequency drug-resistant HIV-1 and risk of virological failure to first-line NNRTI-based ART: a multi-cohort European case-control study using centralized ultrasensitive 454 sequencing. Antivir Ther 2013; 18 Suppl 1: A41.
40. Frentz D, Boucher CA, van de Vijver DA. Temporal changes in the epidemiology of transmission of drug-resistant HIV-1 across the world. AIDS Rev 2012; 14: 17-27.
41. Parikh UM, Kiepiela P, Ganesh S et al. IPTc Taskforce. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009). PLoS One 2013; 8: e59787.
42. Li JZ, Paredes R, Ribaudo HJ et al. Impact of minority nonnucleoside reverse transcriptase inhibitor resistance mutations on resistance genotype after virologic failure. J Infect Dis 2013; 207: 893-7.