Generic and branded drugs for the treatment of people living with HIV/AIDS

Journal of the International Association of Physicians in AIDS Care

Volumn 6, Issue 1, 2007, Pages 15-23

  Bartlett, John A ^a   Muro, Eva P ^b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b KILIMANJARO CHRISTIAN MEDICAL CENTRE   (Tanzania)

Author keywords

AIDS; antiretroviral; generic; HIV; innovator; PEPFAR; WHO Prequalification Project

Indexed keywords

ANTIRETROVIRUS AGENT; GENERIC DRUG;

ECONOMICS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEGAL ASPECT; PATENT; PHARMACOKINETICS; REVIEW;

ANTI-RETROVIRAL AGENTS; DRUGS, GENERIC; HIV INFECTIONS; HUMANS; PATENTS; THERAPEUTIC EQUIVALENCY;

EID: 34248525110     PISSN: 15451097     EISSN: 15570886     Source Type: Journal    
DOI: 10.1177/1545109707299856     Document Type: Article

References (41)

1. World Health Organization Web site. Available at: www.who.org. Accessed November 15, 2006.
2. Bartlett JA, Fath M, DeMasi R, et al. An updated systematic overview of triple combination therapy in antiretroviral-naïve HIV-infected adults. AIDS. 2006 ; 20: 2051-2064. (Pubitemid 44611058)
3. Hogg RS, Yip B, Kully C. Improved survival among HIV-infected patients after initiation of triple-drug antiretroviral regimens. CMAJ. 1999 ; 160: 659-665. (Pubitemid 29149796)
4. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med. 1998 ; 338: 853-860. (Pubitemid 28135961)
5. Mouton Y, Alfandari S, Valette M, et al. Impact of protease inhibitors on AIDS-defining events and hospitalizations in 10 French AIDS reference centers. AIDS. 1997 ; 11: F101 - F105.
6. Sterne JA, Hernan MA, Ledergerber B, et al. Long-term effectiveness of potent antiretroviral therapy in preventing AIDS and death: a prospective cohort study. Lancet. 2005 ; 366: 378-384. (Pubitemid 41073955)
7. Gazzard B. Antiretroviral therapy for HIV: medical miracles do happen. Lancet. 2005 ; 366: 346-347. (Pubitemid 41073943)
8. Joint United Nations Programme on HIV/AIDS. Available at: www.UNAIDS.org. Accessed April 20, 2006.
9. Wainberg MA. Generic HIV drugs - enlightened policy for global health. N Engl J Med. 2005 ; 352: 747-750. (Pubitemid 40271167)
10. Ruxin J, Paluzzi JE, Wilson Y, Kruk M, Teklehaimanot A. Emerging consensus in HIV/AIDS, malaria, tuberculosis, and access to essential medicines. Lancet. 2005 ; 365: 618-621. (Pubitemid 40247921)
11. Food and Drug Administration Web site. Available at: www.fda.gov. Accessed April 20, 2006.
12. European Medicines Agency Web site. Available at: www.emea.europa.eu. Accessed October 20, 2007.
13. Buehler GJ. The FDA process for approving generic drugs. Center for Drug Evaluation and Research, US Food and Drug Administration. Available at: www.fda.gov/cder/ogd/02-10-BCBS-gjb/. Accessed November 15, 2006.
14. Burger D, Boyd M, Duncombe C, et al. Pharmacokinetics and pharmacodynamics of indinavir with or without low-dose ritonavir in HIV-infected Thai patients. J Antimicrob Chemother. 2003 ; 51: 1231-1238. (Pubitemid 36622079)
15. Zala C, Alexander CS, Ochoa C, et al. Comparable pharmacokinetics of generic indinavir (Inhibisam) versus brand indinavir (Crixivan) when boosted with ritonavir. J Acquir Immune Defic Syndr. 2005 ; 38: 363-364. (Pubitemid 40333505)
16. Kumarasamy N. Generic antiretroviral drugs - will they be the answer to HIV in the developing world ? Lancet. 2004 ; 364: 3-4. (Pubitemid 38968606)
17. Machouf N, Thomas R, Nguyen VK, et al. Effects of drug resistance on viral load in patients failing antiretroviral therapy. J Med Virol. 2006 ; 78: 608-613.
18. Deeks SG. Treatment of antiretroviral-drug-resistant HIV-1 infection. Lancet. 2003 ; 362: 2002-2011. (Pubitemid 37548427)
19. Bartlett JA, Buda JJ, von Scheele B, et al. Minimizing resistance consequences after virologic failure on initial combination therapy: a systematic overview. J Acquir Immune Defic Syndr. 2006 ; 41: 323-331.
20. World Trade Organization Web site. Available at: www.wto.org. Accessed April 20, 2006.
21. Barton JH. TRIPS and the global pharmaceutical market. Can the pharmaceutical industry make drugs available to developing countries without compromising its research incentive ? Health Aff. 2004 ; 23: 146-154. (Pubitemid 38639000)
22. Andrade A, Flexner C. Pharmacology at the 12th CROI: generic antiretrovirals, drug interactions, and therapeutic drug monitoring. Hopkins HIV Rep. 2005 ; 17 (3). 6-9.
23. Bale HE Jr. Industry, innovation and social values. Sci Eng Ethics. 2005 ; 11 (1). 31-40.
24. Ramesh R. Drug firms seek to stop generic HIV treatment. The Guardian [ New Delhi, India ]. May 11, 2006.
25. Havlir DV, Hammer SM. Patents versus patients? Anti-retroviral therapy in India. N Engl J Med. 2005 ; 353: 749-751. (Pubitemid 41215481)
26. Schackman B, Gebo K, Walensky R, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006 ; 44: 990-997. (Pubitemid 44674030)
27. Binswanger HP. Public health: HIV/AIDS treatment for millions. Science. 2001 ; 292: 221-223.
28. Medecins Sans Frontieres. Untangling the Web of Price Reductions: A Pricing Guide for the Purchase of ARVs for Developing Countries. 9th ed. July 2006. Available at: www.accessmed.msf.org. Accessed November 7, 2006.
29. Whitelaw K, Parker S. Just the medicine. US News World Rep. 2001 ; 130: 31-31.
30. Perez-Casas C, Herranz E. Pricing of drugs and donations: options for sustainable equity pricing. Trop Med Int Health. 2001 ; 6: 960-964. (Pubitemid 33010886)
31. Ramadhani HO, Thielman NM, Gao F, et al. Predictors of viro-logic failure and HIV drug resistance among patients receiving fixed dose combination stavudine/lamivudine/nevirapine in northern Tanzania. Presented at: 16th International AIDS Conference ; August 13-18, 2006 ; Toronto, Ontario, Canada. Abstract ThLB0213.
32. Antiretroviral Therapy in Lower Income Countries (ARTLINC) Collaboration and ART Cohort Collaboration (ARTCC) Groups. Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries. Lancet. 2006 ; 367: 817-824.
33. Kumarasamy N, Solomon S, Chaguturu SK, et al. The safety, tolerability and effectiveness of generic antiretroviral drug regimens for HIV-infected patients in south India. AIDS. 2003 ; 17: 2267-2269. (Pubitemid 37338904)
34. Kumarasamy N, Solomon S, Chaguturu SK, et al. The changing natural history of HIV disease: before and after the introduction of generic antiretroviral therapy in southern India. Clin Infect Dis. 2005 ; 41: 1525-1528. (Pubitemid 41580000)
35. Kumarasamy N, Vallabhaneni S, Flanigan TP, et al. Rapid viral load suppression following generic highly active antiretroviral therapy in southern Indian HIV-infected patients. AIDS. 2005 ; 19: 625-627. (Pubitemid 40543986)
36. Atul P, Ketan P, Jagdish P, et al. Effectiveness of generic efavirenz-based HAART in HIV-1 infected patients in India: 2 years follow-up. Presented at: 12th Conference on Retroviruses and Opportunistic Infections ; February 22-25, 2005 ; Boston, Mass. Poster 630.
37. Pujari SN, Patel AK, Naik E, 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. (Pubitemid 39658193)
38. Laurent C, Kouanfack C, Koulla-Shiro S, et al. Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavu-dine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial. Lancet. 2004 ; 364: 29-34. (Pubitemid 38968622)
39. Bourgeois A, Laurent C, Mougnutou R, et al. Field assessment of generic antiretroviral drugs: a prospective cohort study in Cameroon. Antivir Ther. 2005 ; 10: 335-341. (Pubitemid 41151040)
40. Hosseinipour MC, Corbett AH, Kanyama C, et al. Pharmacokinetic comparison of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian adults. AIDS. 2007 ; 21: 59-64. (Pubitemid 44912537)
41. Vezina HE, Henry K, Ravindran GD, et al. A randomized crossover study to determine bioequivalence of generic and brand name nevirapine, zidovudine and lamivudine in HIV-negative women in India. J Acquir Immune Defic Syndr. 2006 ; 41: 131-136.