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Introduction

Virological Efficacy of the Four WHO-Recommended Tenofovir-Containing Regimens for Initial Antiretroviral Therapy Michele Tang, MD 1 Phyllis J. Kanki, PhD, DVM 2 Robert Shafer, MD 1 1 Division of Infectious Diseases, Stanford University 2 Harvard School of Public Health. Introduction.

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Introduction

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  1. Virological Efficacy of the Four WHO-Recommended Tenofovir-Containing Regimens for Initial Antiretroviral TherapyMichele Tang, MD1Phyllis J. Kanki, PhD, DVM2Robert Shafer, MD11Division of Infectious Diseases, Stanford University2Harvard School of Public Health

  2. Introduction • 2010 WHO Treatment Guidelines recommend: • Phasing out d4T • Addition of four new TDF containing regimens: TDF/3TC/NVP, TDF/FTC/NVP, TDF/3TC/EFV, TDF/FTC/EFV • TDF is more potent and less toxic than AZT and d4T • However, several studies suggest that TDF/3TC/NVP (and to a lesser extent TDF/FTC/NVP) may have decreased virological efficacy compared with the EFV-containing TDF regimens • The U.S. DHHS Guidelines classify TDF/3TC/NVP as a “Regimen to be Used with Caution”

  3. References (Papers and Abstracts) Screened 1653 Inclusion/Exclusion Criteria Prospective and retrospective studies unless: ARV-experienced patients No virological efficacy results # of individuals receiving each regimen unknown Ten or fewer subjects References Fully Assessed 189 Included Studies 29 TDF/3TC/NVP 3 studies TDF/FTC/NVP 8 studies TDF/3TC/EFV 6 studies TDF/FTC/EFV 14 studies N = 344 N = 3260 N = 684 N = 3873

  4. Studies with TDF/3TC/NVP

  5. GRT with K65R 7/16 (44%) RR and 95%CI of Virological Failure 16/40 (40%) 15/44 (34%) 4/114 (1%)

  6. Summary and Conclusions • TDF/3TC/NVP is the least well-studied of the four TDF-containing regimens, with decreased virological efficacy in 3 available studies. • Plausible explanations include: • Greater in vitro and in vivo activity of EFV vs NVP • Longer intra-cellular half-life of FTC-TP vs 3TC-TP • Contribution of once-daily NVP and 3TC unknown: can be associated with decreased trough concentrations and might increase risk of VF if individual drug dosages are missed. • ARV regimens are more than the sum of their parts: K65R is an Achilles heel for TDF, 3TC and FTC. However, studies suggest that this vulnerability may be counterbalanced either by substitution of EFV for NVP, and, in most studies, by substitution of FTC for 3TC. • Further study of TDF/3TC/NVP is urgently required before this regimen is widely deployed for initial ARV therapy.

  7. Acknowledgements • Dr. Robert Shafer • Dr. Phyllis Kanki • Study Authors • IAS Organizing Committee

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