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COMBIVIR May Help Preserve Future Treatment Options



New patients

Common Mutations at First Virologic Failure on COMBIVIR

  • Most common mutation after virologic failure on regimens containing COMBIVIR is M184V
  • TAMs are rare
  • Next most common mutations relate to the third drug in the regimen - PI or NNRTI

TAMs are Rare at Initial Viral Rebound with COM+PI Therapy1-6

Study Treatment Virologic Failures(n) M184V TAMs PI
------ ----------- ----------- ----- ----- -----
Start I & II COM+IDV 34 59% 0% 6%
AVANTI 2 COM+IDV 11 36% 0% 0%
ACTG 343 COM+IDV 17 82% 0% 0%
ACTG 388 COM+IDV 15 80% 0% 0%
  COM+IDV+NFV 41 44% 0% 0%
AVANTI 3 COM+NFV 7 43% 0% 14%
COMBINE COM+NFV 8 38% 13% 38%


TAMs are Rare at Initial Viral Rebound with COM + NRTI or NNRTI Therapy6-11

Study Treatment Virologic Failures(n) M184V TAMs K65R NNRTI
------ ----------- ----------- ----- ----- ----- -----
CNA3005 COM+ABC 27 78% 22% - -
ESS40013 COM+ABC+EFV 22 50% 9% 9% 64%
CNA30024 COM+EFV 13 46% 0% - 54%
ACTG 384 COM+EFV 109 47% 3% - N/R
EPV20001 COM+EFV 44 32% 7% - 43%
COMBINE COM+NVP 8 13% 0% - 50%
N/R=not reported

  • Clinical relevance of resistance data is currently being evaluated
  • Varying degrees of cross-resistance among HIV NRTIs have been observed
 
 
References
 1. Start I & II - Gulick RM, Eron JJ, Squires K, et al. Virologic failure and resistance with triple combination antiretroviral therapy (START studies I and II). 37th IDSA. 1999: Abst. 442.
 2. AVANTI 2 - Maguire M, Gartland M, Moore S, et al. Absence of zidovudine resistance in antiretroviral-naive patients following zidovudine/lamivudine/protease inhibitor combination therapy: virological evaluation of the AVANTI 2 and AVANTI 3 studies. AIDS. 2000;14:1195-1201.
 3. ACTG343 - Havlir DV, Hellmann NS, Petropoulos CJ, et al. Drug susceptibility in HIV infection after viral rebound in patients receiving indinavir-containing regimens. JAMA. 2000;283:229-234.
 4. ACTG388 - Fischl M, Ribaudo H, Collier A, et al. A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease. J Infect Dis. 2003;188:625-634.
 5. AVANTI 3 - Maguire M, Gartland M, Moore S, et al. Absence of zidovudine resistance in antiretroviral-naive patients following zidovudine/lamivudine/protease inhibitor combination therapy: virological evaluation of the AVANTI 2 and AVANTI 3 studies. AIDS. 2000;14:1195-1201.
 6. COMBINE - Ferrer E, Podzamczer D, Arnedo M, et al. Genotype and phenotype at baseline and at failure in human immunodeficiency virus-infected antiretroviral-naive patients in a randomized trial comparing zidovudine and lamivudine plus nelfinavir or nevirapine. J Infect Dis. 2003;187:687-690.
 7. CNA3005 - Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: a randomized equivalence trial. JAMA. 2001;285:1155-1163.
 8. ESS40013 - Markowitz M, Hill-Zabala C, Lang J, et al. Induction with abacavir/lamivudine/zidovudine plus efavirenz for 48 weeks followed by 48-week maintenance with abacavir/lamivudine/zidovudine alone in antiretroviral-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2005:39:257-264.
 9. CNA30024 - DeJesus E, Herrera G, Teofilo E, et al. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004;39:1038-1046.
 10. 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.
 11. EPV20001 - EPIVIRŪ Tablets (lamivudine tablets)/EPIVIRŪ Oral Solution (lamivudine oral solution) [package insert]. Research Triangle Park, NC:GlaxoSmithKline; November 2005.
  
   


Complete Prescribing Information for COMBIVIR® (lamivudine/zidovudine) Tablets

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