Long-term safety, effectiveness and quality of a generic fixed-dose combination of nevirapine, stavudine and lamivudine

AIDS

Volumn 21, Issue 6, 2007, Pages 768-771

  Laurent, Christian ^a   Kouanfack, Charles ^b   Koulla Shiro, Sinata ^b   Njoume, Maguy ^c   Nkene, Yvette Mawamba ^b   Ciaffi, Laura ^d   Brulet, Charlotte ^c   Peytavin, Gilles ^e   Vergne, Laurence ^a   Calmy, Alexandra ^d   Mpoudi Ngolé, Eitel ^c   Delaporte, Eric ^a  

^a INSTITUT DE RECHERCHE POUR LE DÉVELOPPEMENT   (France)

^b YAOUNDÉ CENTRAL HOSPITAL   (Cameroon)

^c Military Hospital   (Cameroon)

^d MÉDECINS SANS FRONTIÈRES   (Switzerland)

^e BICHAT HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

LAMIVUDINE PLUS NEVIRAPINE PLUS STAVUDINE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG FEVER; DRUG QUALITY; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; SIDE EFFECT; URTICARIA;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LAMIVUDINE; LONG-TERM CARE; MALE; NEVIRAPINE; REVERSE TRANSCRIPTASE INHIBITORS; STAVUDINE; TREATMENT OUTCOME; VIRAL LOAD;

EID: 34147176489     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAD.0b013e328045c4d7     Document Type: Article

References (20)

1. Adelman CC. Ensuring the safety of HIV/AIDS generics. Lancet 2005; 365:1926.
2. Narang VS, Lulla A, Malhotra G, Purandare S. A combined-formulation tablet of lamivudine/nevirapine/stavudine: bioequivalence compared with concurrent administration of lamivudine, nevirapine, and stavudine in healthy Indian subjects. J Clin Pharmacol 2005; 45:265-274.
3. World Health Organization. Procurement, quality and sourcing project: access to HIV/AIDS drugs and diagnostics of acceptable quality. Available at: http://mednet3.who.int/prequal/2001. Accessed: 28 April 2006.
4. Laurent C, Kouanfack C, Koulla-Shiro S, Nkoué N, Bourgeois A, Calmy A, 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.
5. Laurent C, Ngom Gueye NF, Ndour CT, Gueye PM, Diouf M, Diakhaté N, et al. Long-term benefits of highly active anti-retroviral therapy in Senegalese HIV-1-infected adults. J Acquir Immune Defic Syndr 2005; 38:14-17.
6. Coetzee D, Hildebrand K, Boulle A, Maartens G, Louis F, Labatala V, et al. Outcomes after two years of providing antiretroviral treatment in Khayelitsha, South Africa. AIDS 2004; 18:887-895.
7. Martinez V, Marcelin A-G, Morini J-P, Deleuze J, Krivine A, Gorin I, et al. HIV-1 intermittent viraemia in patients treated by non-nucleoside reverse transcriptase inhibitor-based regimen. AIDS 2005; 19:1065-1069.
8. Nettles RE, Kieffer TL, Kwon P, Monie D, Han Y, Parsons T, et al. Intermittent HIV-1 viremia (blips) and drug resistance in patients receiving HAART. JAMA 2005; 293:817-829.
9. Sungkanuparph S, Overton ET, Seyfried W, Groger RK, Fraser VJ, Powderly WG. Intermittent episodes of detectable HIV viremia in patients receiving nonnucleoside reverse-transcriptase inhibitor-based or protease inhibitor-based highly active antiretroviral therapy regimens are equivalent in incidence and prognosis. Clin Infect Dis 2005; 41:1326-1332.
10. Van Leeuwen R, Katlama C, Murphy RL, Squires K, Gatell J, Horban A, et al. A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients. AIDS 2003; 17:987-999.
11. Gulick RM, Mellors JW, Havlir D, Eron JJ, Meibohm A, Condra JH, et al. 3-Year suppression of HIV viremia with indinavir, zidovudine, and lamivudine. Ann Intern Med 2000; 133:35-39.
12. Kumarasamy N, Solomon S, Chaguturu SK, Mahajan AP, Flanigan TP, Balakrishnan P, et al. The safety, tolerability and effectiveness of generic antiretroviral drug regimens for HIV-infected patients in south India. AIDS 2003; 17:2267-2269.
13. Pujari SN, Patel AK, Naik E, Patel KK, Dravid A, Patel JK, et al. Effectiveness of generic fixed-dose combinations of highly active antiretroviral therapy for treatment of HIV infection in India. J Acquir Immune Defic Syndr 2004; 37:1566-1569.
14. Kumarasamy N, Vallabhaneni S, Cecelia AJ, Yepthomi T, Balakrishnan P, Saghayam S, et al. Reasons for modification of generic highly active antiretroviral therapeutic regimens among patients in Southern India. J Acquir Immune Defic Syndr 2006; 41:53-58.
15. Van Oosterhout JJ, Bodasing N, Kumwenda JJ, Nyirenda C, Mallewa J, Cleary PR, et al. Evaluation of antiretroviral therapy results in a resource-poor setting in Blantyre, Malawi. Trop Med Int Health 2005; 10:464-470.
16. Veldkamp AI, Weverling GJ, Lange JMA, Montaner JSG, Reiss P, Cooper DA, et al. High exposure to nevirapine in plasma is associated with an improved virological response in HIV-1-infected individuals. AIDS 2001; 15:1089-1095.
17. Gonzalez de Requena D, Bonora S, Garazzino S, Sciandra M, D'Avolio A, Raiteri R, et al. Nevirapine plasma exposure affects both durability of viral suppression and selection of nevirapine primary resistance mutations in a clinical setting. Antimicrob Agents Chemother 2005; 49:3966-3969.
18. Oyugi JH, Byakika-Tusiime J, Charlebois ED, Kityo C, Mugerwa R, Mugyenyi P, et al. Multiple validated measures of adherence indicate high levels of adherence to generic HIV antiretroviral therapy in a resource-limited setting. J Acquir Immune Defic Syndr 2004; 36:1100-1102.
19. Ramachandran G, Perloff ES, von Moltke LL, Swaminathan S, Wanke CA, Greenblatt DJ. Analysis of generic antiretroviral formulations manufactured in India. AIDS 2004; 18:1482-1484.
20. Penzak SR, Acosta EP, Turner M, Tavel JA, Masur H. Analysis of generic nevirapine products in developing countries. JAMA 2003; 289:2648-2649.