Drug safety evaluation profile of stavudine plus lamivudine for HIV-1/AIDS infection

Expert Opinion on Drug Safety

Volumn 11, Issue 3, 2012, Pages 473-485

  Mateo, Maria Gracia ^a   Gutierrez, Maria Del Mar ^a   Vidal, Francesc ^b   Domingo, Pere ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^b HOSPITAL UNIVERSITARI JOAN XXIII   (Spain)

Author keywords

AIDS; Antiretroviral treatment; HIV 1 infection; Lamivudine; Safety; Stavudine; Toxicity

Indexed keywords

ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; DIDANOSINE; EFAVIRENZ; INDINAVIR; LAMIVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS STAVUDINE; LAMIVUDINE PLUS STAVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR; NEVIRAPINE; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR DISOPROXIL; ZALCITABINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ALBUMIN BLOOD LEVEL; ANEMIA; ARTICLE; CHOLESTEROL BLOOD LEVEL; CONSTIPATION; CREATININE BLOOD LEVEL; DEVELOPING COUNTRY; DIARRHEA; DRUG SAFETY; DRUG SCREENING; DRUG WITHDRAWAL; FATIGUE; HEADACHE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERLACTATEMIA; LACTIC ACIDOSIS; LIPODYSTROPHY; LIVER FUNCTION TEST; LYMPHATIC SYSTEM DISEASE; NAUSEA; NEUROPATHY; PARESTHESIA; PERIPHERAL NEUROPATHY; PHOSPHATE BLOOD LEVEL; RASH; RISK ASSESSMENT; SIDE EFFECT; THROMBOCYTE COUNT; VOMITING; WORLD HEALTH ORGANIZATION;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ANTI-HIV AGENTS; DRUG THERAPY, COMBINATION; EVIDENCE-BASED MEDICINE; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; PATIENT SAFETY; REVERSE TRANSCRIPTASE INHIBITORS; RISK ASSESSMENT; RISK FACTORS; STAVUDINE; TREATMENT OUTCOME;

EID: 84860132550     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.676639     Document Type: Article

References (41)

1. Domingo P, Vidal F. Combination antiretroviral therapy. Expert Opin Pharmacother 2011; [Epub ahead of print]
2. Hogg RS, O'Shaughnessy MV, Gataric N, et al. Decline in deaths from AIDS due to new antiretrovirals. Lancet 1997;349:1294 (Pubitemid 27192475)
3. Crum NF, Riffenburgh RH, Wegner S, et al. Comparisons of causes of death and mortality rates among HIV-infected persons: analysis of the pre-, early, and late HAART (highly active antiretroviral therapy) eras. J Acquir Immune Defic Syndr 2006;41:194-200
4. Palella FJ, Baker RK, Moorman AC, 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 (Pubitemid 44306484)
5. Wang C, Vlahov D, Galai N, et al. Mortality in HIV-Seropositive versus-seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis 2004;190(6):1046-54 (Pubitemid 39186789)
6. 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. January 10, 2011; 1-166. Available from: http://www.aidsinfo.nih. gov/ContentFiles/AdultandAdolescentGL. pdf [Last accessed 4 March 2011]
7. Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treatment of adult HIV infection. 2010 recommendations of the International AIDS Society-USA Panel. JAMA 2010;304(3):321-33
8. European AIDS Clinical Society. Clinical management and treatment of HIV infected adults in Europe. November 22, 2009; 1-25. Available from: http://www. erupeanaidsclinicalsociety.org [Last accessed 4 March 2011]
9. Documento de consenso de Gesida/Plan Nacional sobre el Sida sobre el tratamiento antiretroviral del adulto. Panel de expertos de Gesida y Plan Nacional sobre el Sida. January 2011; 1-239
10. Yeni PG, Hammer SM, Carpenter CCJ, et al. Antiretroviral Treatment for Adult HIV Infection in 2002: updated Recommendations of the International AIDS Society-USA Panel. JAMA 2002;288(2):222-35 (Pubitemid 34755283)
11. World Health Organisation. Addendum to 2006 HIV Treatment Guidelines. Available from: http://www.who.int/hiv/art/ARTadultsaddendum.pdf [Last accessed 22 July 2011]
12. Hill A, Ruxrungtham K, Hanvanich M, et al. Systematic review of clinical trials evaluating low doses of stavudine as part of antiretroviral treatment. Expert Opin Pharmacother 2007;8:1-10
13. World Health Organization. Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents. November 30, 2009;1-28. Available from: http://www.who.int/hiv/pub/arv/advice/en/index.html [Last accessed 4 March 2011]
14. Available from: http://www.ema.europa. eu/findmedicine/humanmedicines/ europeanpublicassessmentreports [Last accessed 4 March 2011]
15. Weller IV, Williams IG. ABC of AIDS. Antiretroviral drugs. BMJ 2001;322(7299):1410-12
16. Dieterich DT. Long-term complications of nucleoside reverse transcriptase inhibitor therapy. AIDS Read 2003;13:176-87 (Pubitemid 36749061)
17. Brinkman K, Smeitink JA, Romijn JA, et al. Mitochondrial toxicity induced by nucleoside-analogue reverse-transcriptase inhibitors is a key factor in the pathogenesis of antiretroviral-therapy-related lipodystrophy. Lancet 1999;354:1112-15 (Pubitemid 29452832)
18. Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and Safety of Tenofovir DF vs Stavudine in Combination Therapy in Antiretroviral-Naive Patients. A 3-Year Randomized Trial. JAMA 2004;292(2):191-201 (Pubitemid 38917996)
19. Cassetti I, Madruga JV, Suleiman JM, et al. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naive HIV-1-infected patients. HIV Clin Trials 2007;8:164-72 (Pubitemid 47121761)
20. Van Leth F, Hassink E, Phanuphak P, et al. Results of the 2NN Study: 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 [abstract 176]. 10th Conference on Retroviruses and Opportunistic Infections; 10-14 Feb 2003; Boston
21. Van Leth F, Hall DB, Lange JMA, et al. Plasma lipid concentrations after 1.5 years of exposure to nevirapine or efavirenz together with stavudine and lamivudine. HIV Med 2006;7:347-50 (Pubitemid 44123243)
22. Haubrich RH, Riddler SA, DiRienzo AG, et al. Metabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatment. AIDS 2009;23(9):1109-18
23. Huang J, Hughes M, Riddler S, et al. Effects of randomized regimen and nucleoside reverse transcriptase inhibitor (NRTI) selection on 96 week bone mineral density (BMD): results from ACTG 5142 [abstract WEAB0304]. Program and abstracts of the 18th International AIDS Conference; 18-23 July 2010; Vienna, Austria
24. Ratsela A, Polis M, Dhlomo S, et al. A randomized factorial trial comparing 4 treatment regimens in treatment-naive HIV-infected persons with AIDS and/or a CD4 cell count < 200 cells/muL in South Africa. J Infect Dis 2010;202(10):1529-37
25. Joly V, Flandre P, Meiffredy V, et al. Efficacy of zidovudine compared to stavudine, both in combination with lamivudine and indinavir, in human immunodeficiency virus-infected nucleoside-experienced patients with no prior exposure to lamivudine, stavudine, or protease inhibitors (Novavir Trial). Antimicrob Agents Chemother 2002;46(6):1906-13 (Pubitemid 34535214)
26. Joly V, Flandre P, Meiffredy V, et al. Increased risk of lipoatrophy under stavudine In HIV-1-infected patients: results of a substudy from a comparative trial. AIDS 2002;16(18):2447-54 (Pubitemid 35471693)
27. Squires KE, Gulick R, Tebas P, et al. A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I). AIDS 2000;14(11):1591-600
28. Carr A, Chuah J, Hudson J, et al. A randomised, open-label comparison of three highly active antiretroviral therapy regimens including two nucleoside analogues and indinavir for previously untreated HIV-1 infection: the OzCombo1 study. AIDS 2000;14(9):1171-18
29. French M, Amin J, Roth N, et al. Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 infection: the OzCombo2 Study. HIV Clin Trials 2002;3(3):177-85 (Pubitemid 34704865)
30. Kumar PN, Rodriguez-French A, Thompson MA, et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/ nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Medicine 2006;7:85-98
31. Podzamczer D, Ferrer E, Sanchez P, et al. ABCDE (Abacavir vs. d4T (stavudine) plus efavirenz) Study Team. Less lipoatrophy and better lipid profile with abacavir as compared to stavudine: 96-week results of a randomized study. Acquir Immune Defic Syndr 2007;44:139-47 (Pubitemid 46292215)
32. Sacktor N, Nakasujja N, Skolasky RL, et al. Benefits and risks of stavudine therapy for HIV-associated neurologic complications in Uganda. Neurology 2009;72(2):165-70
33. Zhou J, Paton NI, Ditangco R, et al. Experience with the use of a first-line regimen of stavudine, lamivudine and nevirapine in patients in the treat Asia HIV observational database. HIV Med 2007;8:8-16 (Pubitemid 46117835)
34. Mouhari-Toure A, Saka B, Kombat K, et al. Clinical safety of a generic fixed-dose combination of stavudine/lamivudine/nevirapine (Triomune). Study of 297 cases in Togo. Bull Soc Pathol Exot 2008;101:404-6
35. Manosuthi W, Chimsuntorn S, Likanonsakul S, et al. Safety and efficacy of a generic fixed-dose combination of stavudine, lamivudine and nevirapine antiretroviral therapy between HIV-infected patients with baseline CD4 < 50 versus CD4 > or = 50 cells/mm3. AIDS Res Ther 2007;13:4-6
36. Getahun A, Tansuphasawadikul S, Desakorn V, et al. Efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and nevirapine (gpo-vir) in advanced HIV infection. J Med Assoc Thai 2006;89(9):1472-8 (Pubitemid 44510686)
37. Anekthananon T, Tatanasuwan W, Techasathit W, et al. Safety and efficacy of a simplified fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) for the treatment of advanced HIV-infected patients: a 24-week study. J Med Assoc Thai 2004;87(7):760-7 (Pubitemid 39166076)
38. Srirangaraj S, Venkatesha D. Adverse effects after HAART Initiation in resource-limited settings: a prospective study from Mysore, India. J Infect Dev Ctries 2010;4(11):750-3
39. Laurent C, Kovanfack CH, Koulla-chiro S, et al. Effectiveness and safety of a generic fixed dose combination of nevirapine, stavudine and lamivudine in HIV-1-infected adults in Cameroon: open label multicentre trial. Lancet 2004;364:29-34 (Pubitemid 38968622)
40. Ribera E, Paradineiro JC, Domingo P, et al. A randomized study comparing the efficacy and tolerability of low-dose versus standard-dose stavudine in antiretroviral-naive patients (ETOX Study) [abstract TuPe2.4c10]. 3rd International Conference on EIDS Pathogenesis; July 2005; Rio de Janeiro, Brazil
41. Sanchez-Conde M, Soriano V, Gonzalez-Lahoz J. Dose reduction in stavudine from 40 to 30 mg bid provides similar virological and immunological benefit [abstract TuPeB4459]. 15th International Conference on AIDS; 11-16 July 2004; Bangkok, Thailand