Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: A randomized trial

Journal of Infectious Diseases

Volumn 191, Issue 6, 2005, Pages 830-839

  Molina, Jean Michel ^a,f   Journot, Valérie ^b   Morand Joubert, Laurence ^a   Yéni, Patrick ^a   Rozenbaum, Willy ^a   Rancinan, Corinne ^b   Fournier, Sandra ^a   Morlat, Philippe ^c   Palmer, Pierre ^a   Dupont, Bertrand ^a   Goujard, Cécile ^a   Dellamonica, Pierre ^d   Collin, Fidéline ^b   Poizot Martin, Isabelle ^e   Chêne, Geneviève ^b  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b INSERM   (France)

^c HÔPITAL SAINT ANDRÉ   (France)

^d CENTRE HOSPITALIER UNIVERSITAIRE DE NICE   (France)

^e HÔPITAL SAINTE MARGUERITE   (France)

^f SAINT LOUIS HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

DIDANOSINE; EFAVIRENZ; EMTRICITABINE; INDINAVIR; LAMIVUDINE; NELFINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; VIRUS RNA; ZIDOVUDINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY DISEASE; LIPOATROPHY; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VIRUS INHIBITION;

ADULT; ANTI-HIV AGENTS; DEOXYCYTIDINE; DIDANOSINE; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; MIDDLE AGED; OXAZINES; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; TREATMENT OUTCOME;

EID: 20044391202     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/428091     Document Type: Article

References (35)

1. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998; 338:853-60.
2. Mocroft A, Ledergerber B, Katlama C, et al. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet 2003; 362:22-9.
3. Murphy EL, Collier AC, Kalish LA, et al. Highly active antiretroviral therapy decreases mortality and morbidity in patients with advanced HIV disease. Ann Intern Med 2001; 135:17-26.
4. Yeni PG, Hammer SM, Hirsch M, et al. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA 2004; 292:251-65.
5. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133:21-30.
6. Haubrich RH, Little SJ, Currier JS, et al. The value of patient-reported adherence to antiretroviral therapy in predicting virologic and immunologic response. AIDS 1999; 13:1099-107.
7. Mannheimer S, Friedland G, Matts J, Child C, Chesney M, for the Terry Beirn Community Programs for Clinical Research on AIDS. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin Infect Dis 2002; 34:1115-21.
8. Low-Beer S, Yip B, O'Shaughnessy MV, Hogg RS, Montaner JS. Adherence to triple therapy and viral load response. J Acquir Immune Defic Syndr 2000; 23:360-1.
9. Sethi AK, Celentano DD, Gange SJ, Moore RD, Gallant JE. Association between adherence to antiretroviral therapy and human immunodeficiency virus drug resistance. Clin Infect Dis 2003; 37:1112-8.
10. 9 cells/L. Ann Intern Med 2003; 139:810-6.
11. Carr A, Samaras K, Thorisdottir A, et al. Diagnosis, prediction, and natural course of HIV-1 protease inhibitor associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet 1999; 353:2093-9.
12. Martinez E, Mocroft A, Garcia-Viejo MA, et al. Risk of lipodystrophy in HIV-1-infected patients treated with protease inhibitors: a prospective cohort study. Lancet 2001; 357:592-8.
13. Mary-Krause M, Cotte L, Simon A, et al. Increased risk of myocardial infarction with duration of protease inhibitor therapy in HIV-infected men. AIDS 2003; 17:2479-86.
14. Murphy RL, Smith WJ. Switch studies: a review. HIV Med 2002; 3: 146-55.
15. Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis 2002; 35:1219-30.
16. Martinez E, Arnaiz JA, Podzamczer D, et al. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med 2003; 349:1036-46.
17. Becker S, Rachlis A, Gill J, et al. Successful substitution of protease inhibitors with efavirenz in patients with undetectable viral loads - a prospective, randomized, multicenter open-labeled study (DMP 049) [abstract 20]. In: Program and abstracts of the 8th Conference on Retroviruses and Opportunistic Infections (Chicago). Alexandria, VA: Foundation for Retrovirology and Human Health, 2001.
18. Hirschel B, Flepp M, Bucher HC, et al. Switching from protease inhibitors to efavirenz: differences in efficacy and tolerance among risk groups: a case-control study from the Swiss HIV Cohort. AIDS 2002; 16:381-5.
19. Molina J-M, Ferchal F, Rancinan C, et al. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis 2000; 182:599-602.
20. Jung M, Agut H, Candotti D, Ingrand D, Katlama C, Huraux JM. Susceptibility of HIV-1 isolates to zidovudine: correlation between widely applicable culture test and PCR analysis. J Acquir Immune Defic Syndr 1992; 5:359-64.
21. D'Aquila RT, Schapiro JM, Brun-Vézinet F, et al. Drug resistance mutations in HIV-1. Top HIV Med 2003; 11:92-6.
22. Chene G, Angelini E, Cotte L, et al. Role of long-term nucleoside-analogue therapy in lipodystrophy and metabolic disorders in human immunodeficiency virus-infected patients. Clin Infect Dis 2002; 34:649-57.
23. Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care 2000; 12:255-66.
24. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep 1992; 41:1-19.
25. Saag MS, Cahn P, Rafft F, et al. Efficacy and safety of emtricitabine vs. stavudine in combination therapy in antiretroviral-naive patients: a randomized trial. JAMA 2004; 292:180-90.
26. Richman DD. Antiviral activity of emtricitabine, a potent nucleoside reverse transcriptase inhibitor. Antiviral Ther 2001; 6:83-8.
27. Wang LH, Begley J, St. Claire RL III, Harris J, Wakeford C, Rousseau FS. Pharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing. AIDS Res Hum Retroviruses 2004; 20:1173-82.
28. Taburet A-M, Paci-Bonaventure S, Peytavin G, Molina J-M. Once-daily administration of antiretrovirals. Clin Pharmacokinet 2003; 42:1179-91.
29. Benson CA, van der Horst, LaMarca A, et al. A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV. AIDS 2004; 18:2269-76.
30. Van Leth F, Phanuphak P, Gazzard B, et al. Lipid changes in a randomized comparative trial of first-line antiretroviral therapy with regimens containing either nevirapine alone, efavirenz alone, or both drugs combined, together with stavudine and lamivudine (2NN study) [abstract 752]. In: Program and abstracts of the 10th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2003.
31. Dubé MP, Stein JH, Aberg JA, et al. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV medicine association of the infectious disease society of America and the adult AIDS clinical trials group. Clin Infect Dis 2003; 37:613-27.
32. Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med 2003; 349:1993-2003.
33. Saint-Marc T, Partisani M, Poizot-Martin I, et al. Fat distribution evaluated by computed tomography and metabolic abnormalities in patients undergoing antiretroviral therapy: preliminary results of the LIPOCO study. AIDS 2000; 14:37-49.
34. Carr A, Miller J, Law M, Cooper DA. A syndrome of lipoatrophy, lactic academia and liver dysfunction associated with HIV nucleoside analogue therapy: contribution to protease inhibitor-related lipodystrophy syndrome. AIDS 2000; 14:F25-32.
35. Joly V, Flandre P, Meiffredy V, et al. Increased risk of lipoatrophy under stavudine in HIV-infected patients: results of a substudy from a comparative trial. AIDS 2002; 16:2447-54.