Effectiveness

d4T (stavudine, Zerit) is able to reduce HIV viral load and increase CD4 cell counts in the majority of people when taken in combination with at least two other antiretroviral drugs. It is regarded as an alternative to AZT (zidovudine, Retrovir) as a basis for multi-drug combinations, with early studies showing comparative virological results of the two drugs when combined with 3TC (lamivudine, Epivir) and indinavir (Crixivan).1 2 The first of these studies revealed that patients taking d4T had larger increases in CD4 cell counts than those taking AZT.1

d4T crosses the blood-brain barrier and is effective against HIV in the brain and the central nervous system.3

d4T was first licensed after a clinical study showed that d4T monotherapy reduced the rates of death and progression to AIDS, when compared to AZT. All of the patients had taken AZT for at least six months before entry into the study.4 This conclusion was confirmed by a large trial of over 13,000 patients that assessed the effectiveness of d4T in patients who had experienced failure of treatment with AZT, ddI (didanosine, Videx / VidexEC) or ddC (zalcitabine, Hivid).5

More recently, studies comparing the standard version of d4T to a new extended release version have provided evidence of the drug’s effectiveness when combined with 3TC (lamivudine, Epivir) and efavirenz (Sustiva). Two separate studies showed that triple drug combinations including d4T were safe and effective in patients who had not taken any anti-HIV drugs before and those with treatment experience.6 7

However, due to d4T's long-term, irreversible side-effects, the World Health Organization recommended in late 2009 that d4T use be phased out in all countries.

References

  1. Squires KE 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 14: 1591-1600, 2000
  2. Carr A 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 14: 1171-1180, 2000
  3. Brady KA et al. Stavudine entry into cerebrospinal fluid after single and multiple doses in patients infected with human immunodeficiency virus. Pharmacotherapy 25: 10-17, 2005
  4. Spruance SL et al. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine / 019 Study Group. Ann Intern Med 126: 355-363, 1997
  5. Gottlieb M et al. Comparison of safety and efficacy of two doses of stavudine in a simple trial in the US parallel track program. 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, abstract I171, 1995
  6. Brett-Smith H et al. 48-week efficacy results: stavudine extended release formulation as compared to stavudine immediate release formulation. 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, abstract H-162, 2002
  7. Brett-Smith HM et al. Two year analysis of stavudine extended-release / prolonged release capsules (XR / PRC) as compared to stavudine immediate-release (IR): efficacy and safety. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, abstract H-843, 2003
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