Effectiveness and safety of 30 mg versus 40 mg stavudine regimens: A cohort study among HIV-infected adults initiating HAART in South Africa

Journal of the International AIDS Society

Volumn 15, Issue 1, 2012, Pages

  Maskew, Mhairi ^a,e   Westreich, Daniel ^b   Fox, Matthew P ^a,c   Maotoe, Thapelo ^d   Sanne, Ian M ^a,d  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^d RIGHT TO CARE   (South Africa)

^e Health Economics and Epidemiology Research Office   (South Africa)

Author keywords

Antiretroviral toxicity; Cohort study; Resource limited setting; Stavudine; Virologic failure

Indexed keywords

EFAVIRENZ; LAMIVUDINE; NEVIRAPINE; STAVUDINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLACTATEMIA; LACTIC ACIDOSIS; LIPOATROPHY; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SENSITIVITY ANALYSIS; SOUTH AFRICA; TREATMENT FAILURE; TREATMENT OUTCOME; VIRUS LOAD; CD4 LYMPHOCYTE COUNT; COHORT ANALYSIS; COMPARATIVE STUDY; DOSE RESPONSE; DRUG EFFECT; HUMAN IMMUNODEFICIENCY VIRUS; IMMUNOLOGY; PHYSIOLOGY; VIROLOGY;

ADULT; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HIV; HIV INFECTIONS; HUMANS; MALE; PROSPECTIVE STUDIES; SOUTH AFRICA; STAVUDINE;

EID: 84857947110     PISSN: None     EISSN: 17582652     Source Type: Journal    
DOI: 10.1186/1758-2652-15-13     Document Type: Article

References (44)

1. Positive outcomes of HAART at 24 months in HIV-infected patients in Cambodia. Ferradini L, Laureillard D, Prak N, Ngeth C, Fernandez M, Pinoges L, Puertas G, Taburet A, Ly N, Rouzioux C, Balkan S, Quillet C, Delfraissy J, AIDS 2007 21 2293 2301 10.1097/QAD.0b013e32828cc8b7 18090277 (Pubitemid 350287455)
2. Efficacy and safety of Tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JMAH, Miller MD, Coakley DF, Lu B, Toole JJ, Cheng AK, JAMA 2004 292 191 201 10.1001/jama.292.2.191 15249568 (Pubitemid 38917996)
3. Association of serum lipid levels with HIV serostatus, specific antiretroviral agents, and treatment regimens. Anastos K, Lu D, Shi Q, Tien PC, Kaplan RC, Hessol N, Cole S, Vigen C, Cohen M, Young M, Justman J, J Acquir Immune Defic Syndr 2007 45 34 42 10.1097/QAI.0b013e318042d5fe 17460470 (Pubitemid 46684441)
4. Metabolic effects associated to the highly active antiretroviral therapy (HAART) in AIDS patients. Domingos H, Cunha RVD, Paniago AMM, Martins DM, Elkhoury EB, Souza ASD, Braz J Infect Dis 2009 13 130 136 20140358
5. Stavudine- and nevirapine-related drug toxicity while on generic fixed-dose antiretroviral treatment: incidence, timing and risk factors in a three-year cohort in Kigali, Rwanda. van Griensven J, Zachariah R, Rasschaert F, Mugabo J, Atté EF, Reid T, Trans R Soc Trop Med Hyg 2010 104 148 153 10.1016/j.trstmh.2009.07.009 19732926
6. Antiretroviral therapy-associated toxicities in the resource-poor world: the challenge of a limited formulary. Murphy R, Sunpath H, Kuritzkes DR, Venter F, Gandhi RT, J Infect Dis 2007 196 Suppl3 449 456 18181693
7. Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study. Ait-Mohand H, Bonmarchand M, Guiguet M, Slama L, Marguet F, Behin A, Amellal B, Bennai Y, Peytavin G, Calvez V, Pialoux G, Murphy R, Katlama C, HIV Med 2008 9 738 746 10.1111/j.1468-1293.2008.00616.x 18651858
8. Reduced dose of stavudine and lipoatrophy in HIV-infected patients in Cameroon. Cournil A, Coudray M, Kouanfack C, Essomba CN, Tonfack CAD, Biwolé-Sida M, Delaporte E, Bork K, Laurent C, Antivir Ther 2010 15 1039 1043 10.3851/IMP1664 21041920
9. Efficacy and safety of a reduced-dose of stavudine in HIV-infected patients under immunological and virological stable conditions. Pedrol E, Martín T, del Pozo MA, Flores J, Sanz J, Cartán JA, Jusdado J-J, Arazo P, Ribera E, Deig E, Med Clin 2007 129 361 365 10.1157/13110209 (Pubitemid 47574101)
10. Hanvanich M, Prasanthai V, Riengchan P, Arunyingmongkol K, Intalapaporn P, Hiransuthikul N, Suankratay C, Kulwichit W, Reduction of D4T dosage improves lipoatrophy without virologic failure The 2nd IAS Conference on HIV Pathogenesis and Treatment 2003 [Abstract no.749]
11. Delpierre C, Cuzin L, Alvarez M, Khatibi S, Bonnet E, Obadia M, Massip P, Lowering stavudine dosages does not compromise anti-viral efficacy in HIV-1 infected patients. The 9th European AIDS Conference 2003 [Abstract no.262]
12. Koegl C, Wolf E, Postel N, Buchberger A, Ruemmelein N, Jaegel-Guedes E, Jaeger H, Low dose stavudine: as effective as standard dose but less side effects The 9th European AIDS Conference 2003 [Abstract no.284]
13. Urbina A, Jibilian A, Nibbe Y, Maa JF, Wang S, Long Term Use of Low dose Stavudine is Effective and Well Tolerated The 3rd IAS Conference on HIV Pathogenesis and Treatment 2005 [Abstract no. TuPe2.2B31]
14. Ribera E, Paradĩeiro JC, Domingo P, Sauleda S, Luque S, Garcia-Arumi E, Feijoo M, Fontanet A, Falco V, Crespo M, Ocana I, Sureda D, Planas M, Pahissa A, A randomized study comparing the efficacy and tolerability of low-dose versus standard-dose stavudine in antiretroviral-nave patients (ETOX Study) The 3rd IAS Conference on HIV Pathogenesis and Treatment 2005 [Abstract no. TuPe2.4 C10]
15. World Health Organization, Addendum to 2006 WHO Guidelines on Antiretroviral Therapy for HIV Infection in Adults and Adolescents Geneva 2007
16. World Health Organization, Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach: 2010 revision Geneva 2010
17. The impact of reducing stavudine dose versus switching to Tenofovir on plasma lipids, body composition and mitochondrial function in HIV-infected patients. Milinkovic A, Martinez E, Lápez S, de Lazzari E, Mirá O, Vidal S, Blanco JL, Garrabou G, Laguno M, Arnaiz JA, Leon A, Larrousse M, Lonca M, Mallolas J, Gatell JM, Antivir Ther 2007 12 407 415 17591031 (Pubitemid 46787986)
18. Ruiz Camps MI, Llibre JM, Moreno S, and the RECOVER study group: Improvement of dyslipidemia in patients switching from stavudine to tenofovir: preliminary results. Domingo P, Labarga P, Palacios R, Guerrero MF, Terron JA, Elias MJP, Santos J, AIDS 2004 18 1475 1478 10.1097/01.aids.0000131343.53419.04 15199328 (Pubitemid 38925144)
19. Sustained improvement of dyslipidaemia in HAART- treated patients replacing stavudine with tenofovir. Llibre JM, Domingo P, Palacios R, Miralles C, Pe MJ, AIDS 2006 20 1407 1414 10.1097/01.aids.0000233574.49220.de 16791015 (Pubitemid 43948247)
20. for the RAVE (Randomized Abacavir versus Viread Evaluation) group UK: A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy. Moyle GJ, Sabin CA, Cartledge J, Wilkins E, Churchill D, Hay P, Fakoya A, Murphy M, Scullard G, Leen C, Reilly G, AIDS 2006 20 2043 2050 10.1097/01.aids.0000247574.33998.03 17053350 (Pubitemid 44611057)
21. Resistance development over 144 weeks in treatment-naive patients receiving Tenofovir disoproxil fumarate or stavudine with lamivudine and efavirenz in Study 903. Margot NA, Lu B, Cheng A, Miller MD, HIV Med 2006 7 442 450 10.1111/j.1468-1293.2006.00404.x 16925730 (Pubitemid 44269811)
22. Lipodystrophy and dyslipidemia among patients taking first-line, World Health Organization-recommended highly active antiretroviral therapy regimens in Western India. Pujari SN, Dravid A, Naik E, Bhagat S, Tash K, Nadler JP, Sinnott JT, J Acquir Immune Defic Syndr 2005 39 199 202 15905737 (Pubitemid 40741119)
23. World Health Organization, Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector Progress Report Geneva 2010
24. Reductions in stavudine dose might ameliorate mitochondrial-associated complications without compromising antiviral activity. Sánchez-Conde M, de Mendoza C, Jiménez-Nacher I, Barreiro P, Gonzalez-Lahoz J, Soriano V, HIV Clin Trials 2005 6 197 202 10.1310/ED57-EU48-RK6A-E5U0 16214736 (Pubitemid 41601131)
25. National Department of Health, Clinical guidelines for the management of HIV & AIDS in adults and adolescents South Africa 2010 22409869
26. National Department of Health, Clinical guidelines for the management of HIV & AIDS in adults and adolescents South Africa 2004 22409869
27. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Hernán MA, Brumback B, Robins JM, Epidemiology 2000 11 561 570 10.1097/00001648-200009000-00012 10955409 (Pubitemid 30660035)
28. Use of antiretroviral therapy in resource-limited countries in 2006: distribution and uptake of first- and second-line regimens. Renaud-Théry F, Nguimfack BD, Vitoria M, Lee E, Graaff P, Samb B, Perrins J, AIDS 2007 21 Suppl4 89 S95 18172397
29. Improving first-line antiretroviral therapy in resource-limited settings. Ford N, Calmy A, Curr Opin HIV AIDS 2010 5 38 47 10.1097/COH.0b013e3283339b41 20046146
30. Stavudine: A Review. Fuchs J, Pollard R, Braz J Infect Dis 1998 2 10 17 11101906
31. World Health Organization, Scaling up antiretroviral therapy in resource-limited settings. Guidelines for a public health approach Geneva 2002
32. HIV and HIV treatment: effects on fats, glucose and lipids. Gkrania-Klotsas E, Klotsas A-E, Br Med Bull 2007 84 49 68 10.1093/bmb/ldm030 17981955
33. HIV and antiretroviral therapy: lipid abnormalities and associated cardiovascular risk in HIV-infected patients. Kotler DP, J Acquir Immune Defic Syndr 2008 49 Suppl 2 79 S85 18725816
34. Spectrum of adverse events after generic HAART in southern Indian HIV-infected patients. Kumarasamy N, Venkatesh KK, Cecelia AJ, Devaleenal B, Lai AR, Saghayam S, Balakrishnan P, Yepthomi T, Poongulali S, Flanigan TP, Solomon S, Mayer KH, AIDS Patient Care STDS 2008 22 337 344 10.1089/apc.2007.0093 18422462 (Pubitemid 351562965)
35. Effect of reducing the dose of stavudine on body composition, bone density, and markers of mitochondrial toxicity in HIV-infected subjects: a randomized, controlled study. McComsey GA, Lo Re V, O'Riordan M, Walker UA, Lebrecht D, Baron E, Mounzer K, Frank I, Clin Infect Dis 2008 46 1290 1296 10.1086/529384 18444869 (Pubitemid 351589916)
36. Systematic review of clinical trials evaluating low doses of stavudine as part of antiretroviral treatment. Hill A, Ruxrungtham K, Hanvanich M, Katlama C, Wolf E, Soriano V, Milinkovic A, Gatell J, Ribera E, Expert Opin Pharmacother 2007 8 679 688 10.1517/14656566.8.5.679 17376022 (Pubitemid 46547020)
37. Comparative tolerability and efficacy of stavudine 30 mg versus stavudine 40 mg in patients on combination antiretroviral therapy in Kenya. Karara MW, Okalebo FA, Ng M, Ombega J, Guantai AN, Osanjo GO, J AIDS HIV Res 2010 2 024 031
38. HIV suppression with stavudine 30 mg versus 40 mg in adults over 60 kg on antiretroviral therapy in South Africa. Hoffmann CJ, Charalambous S, Fielding KL, Innes C, Chaisson RE, Grant AD, Churchyard GJ, AIDS 2009 23 1784 1786 10.1097/QAD.0b013e32832e0585 19491652
39. Implementing a tenofovir-based first-line regimen in rural Lesotho: clinical outcomes and toxicities after two years. Bygrave H, Ford N, van Cutsem G, Hilderbrand K, Jouquet G, Goemaere E, Vlahakis N, Trivĩo L, Makakole L, Kranzer K, J Acquir Immune Defic Syndr 2011 56 75 e78 10.1097/QAI. 0b013e3182097505 21164354
40. on behalf of the Treat Asia HIV Observational Database (TAHOD): Prior antiretroviral therapy experience protects against zidovudine-related anaemia. Huffam SE, Srasuebkul P, Zhou J, Calmy A, Saphonn V, Kaldor JM, Ditangco R, HIV Med 2007 8 465 471 10.1111/j.1468-1293.2007.00498.x 17760739 (Pubitemid 47335269)
41. Switching effective antiretroviral therapy: A review. Drechsler H, Powderly WG, Clin Infect Dis 2002 35 1219 1230 10.1086/343050 12410482 (Pubitemid 35305870)
42. Relationship between renal dysfunction, nephrotoxicity and death among HIV-positive adults on Tenofovir. Brennan AT, Evans D, Maskew M, Naicker S, Ive P, Sanne I, Maotoe T, Fox MP, AIDS
43. Changes in renal function associated with Tenofovir Disoproxil Fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment. Gallant JE, Parich MA, Keruly JC, Moore RD, Clin Infect Dis 2005 40 1194 1198 10.1086/428840 15791522 (Pubitemid 40490248)
44. South African National Department of Health, RT71-2010MF Reference Price List 2010 http://www.tac.org.za/userfiles/RT71-2010MFContractCircular1.pdf