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Why Prescribe COMBIVIR
Why Keep Patients on COMBIVIR
Safety and Tolerability
Efficacy
Dosing Convenience
Patient Education
Important Safey Information
Questions Frequently Asked by Patients
Prescribing Info
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Efficacy



COMBIVIR or its components remain the backbone for many of the most commonly prescribed first-line regimens 1,2. ZDV/3TC demonstrated efficacy in many clinical trials.


Proven efficacy in three of the longest running clinical trials


  • At 3 years, 55% of patients treated with COMBIVIR plus EFV in DMP006 had viral load <400 c/mL; 52% had viral load <50 c/mL19
  • 9% of patients on COMBIVIR plus EFV discontinued therapy as a result of adverse events between weeks 1 and 14419

  • At 4 years, 62% of patients treated with COMBIVIR plus NFV in Agouron 511 had viral load <400 c/mL; 52% had viral load <50 c/mL20
  • Mean increase in CD4 cell count was 403 cell/mm3 20

  • At 6 years in Merck 035, the majority (53%) of patients treated with ZDV/3TC/IDV maintained viral loads <500 c/mL (47% maintained viral load <50 c/mL)21



  • Trend favoring a delay in the time to treatment failure with a second regimen when COMBIVIR/EFV is the first regimen compared to ddI/d4T/EFV22
  • Initial treatment with COMBIVIR/EFV vs ddI/d4T/EFV significantly delayed time to first virologic failure22


References
 1. Department of Health and Human Services. HIV Treatment Guidelines. October 6, 2005. Available at: http//www.aidsinfo.nih.gov/. Accessed February 24, 2006.
 2. Synovate 2005, Q3.
 3. Rescriptor® (delavirdine mesylate) [package insert]. La Jolla, CA: Agouron Pharmaceuticals; June 2001.
 4. EPIVIR® Tablets (lamivudine tablets)/EPIVIR® Oral Solution (lamivudine oral solution) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; November 2005.
 5. Ungsedhapand C, Kroon EDMB, Suwanagool S, et al. A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naïve HIV-1-infected Thai patients. J Acquir Immune Defic Syndr. 2001;27:116-123.
 6. Podzamczer D, Ferrer E, Consiglio E, et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naïve patients (the Combine Study). Antivir Ther. 2002;7:81-90.
 7. Gartland M. AVANTI 3: a randomized, double-blind trial to compare the efficacy and safety of lamivudine plus zidovudine versus lamivudine plus zidovudine plus nelfinavir in HIV-1-infected antiretroviral-naïve patients. Antivir Ther. 2001;6:127-134.
 8. The AVANTI Study Group. AVANTI 2. Randomized, double-blind trial to evaluate the efficacy and safety of zidovudine plus lamivudine versus zidovudine plus lamivudine plus indinavir in HIV-infected antiretroviral-naïve patients. AIDS. 2000;14:367-374.
 9. 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 OzCombo 2 study. HIV Clin Trials. 2002;3:177-185.
 10. 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 OzCombo 1 study. AIDS. 2000;14:1171-1180.
 11. Matheron S, Descamps D, Boue F, et al. Triple nucleoside combination zidovudine/lamivudine/abacavir versus zidovudine/lamivudine/nelfinavir as first-line therapy in HIV-1-infected adults: a randomized trial. Antivir Ther. 2003;8:163-171.
 12. Vibhagool A, Cahn P, Schechter M, et al. Abacavir/COMBIVIR (ABC/COM) is comparable to indinavir/COMBIVIR in HIV-1 infected antiretroviral therapy naïve adults: preliminary results of a 48-week open label study (CNA3014). Abstract presented at: 1st IAS Conference on HIV Pathogenesis and Treatment, 2001; July 2001; Buenos Aires, Argentina. Abstract 63.
 13. Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naïve HIV-infected adults: a randomized equivalence trial. JAMA. 2001;285:1155-1163.
 14. Eron JJ Jr, Murphy RL, Peterson D, et al. A comparison of stavudine, didanosine and indinavir with zidovudine, lamivudine and indinavir for the initial treatment of HIV-1 infected individuals: selection of thymidine analog regimen therapy (START II). AIDS. 2000;14:1601-1610.
 15. Reyataz® (atazanavir sulfate) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; January 2006.
 16. Squires KE, Gulick R, Tebas P, et al. A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naïve individuals with HIV infection: selection of thymidine analog regimen therapy (START I). AIDS. 2000;14:1591-1600.
 17. Staszewski S, Morales-Ramirez J, Tashima KT, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. N Engl J Med. 1999;341:1865-1873.
 18. Saag MS, Tebas P, Sension M, et al. Randomized, double-blind comparison of two nelfinavir doses plus nucleosides in HIV-infected patients (Agouron study 511). AIDS. 2001;15:1971-1978.
 19. Arribas J, Staszewski S, Nelson M, et al. 3-year durability of response with an efavirenz (EFV)-containing regimen: 144-week follow-up of Study 006. Presented at: 11th European Congress on Clinical Microbiology and Infectious Diseases; April 1-4, 2001; Istanbul, Turkey. Poster 43.
 20. Gathe J Jr, Chu A, Yuen N, et al. Durability of nelfinavir combination therapy after 4 years: 3-year extension data from Agouron Study 511. In: Abstracts of the 8th European Conference on Clinical Aspects and Treatment of HIV-infection; October 28-31, 2001; Athens, Greece. Poster LB10.
 21. Gulick RM, Meibohm A, Havlir D, et al. Six-year follow-up of HIV-1-infected adults in a clinical trial of antiretroviral therapy with indinavir, zidovudine, and lamivudine. AIDS. 2003;17:2345-2349.
 22. Robbins GK, De Gruttola V, Shafer RW, et al. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003; 349: 2293-2303.

 
   


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