Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

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  • Appendix C. Clinical Trial Efficacy Data for Daily, Oral Tenofovir Disoproxil Fumarate/Emtricitabine as Pre-Exposure Prophylaxis

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Appendix C. Clinical Trial Efficacy Data for Daily, Oral Tenofovir Disoproxil Fumarate/Emtricitabine as Pre-Exposure Prophylaxis

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Appendix C. Clinical Trial Efficacy Data for Daily, Oral Tenofovir Disoproxil Fumarate/Emtricitabine as Pre-Exposure Prophylaxis
Studya Population Regimen Efficacy
(95% CI)
Percentage of Participants with Detectable Plasma Levels of TFV
Partners PrEP
(n = 4,758)1
Serodiscordant couples in Kenya and Uganda

n = 1,579 randomized to receive TDF/FTC
TDF/FTC 75% (55% to 87%) 82%b
CDC TDF2
(n = 1,215)2
Heterosexual men and women in Botswana TDF/FTC 63% (22% to 83%) 79%
Fem-PrEP
(n = 2,056)3
Heterosexual women in South Africa, Kenya, and Tanzania TDF/FTC No effect 24%
VOICE
(n = 5,029)4
Heterosexual women in South Africa, Uganda, and Zimbabwe n = 1,003 randomized to receive TDF/FTC TDF/FTC No effect 29%
a The data in this table are from studies that included heterosexual women.
b Among the patients who achieved detectable plasma levels of TFV, the efficacy estimate for daily TDF/FTC was 91% (95% CI, 47% to 98%).4

Key: CI = confidence interval; FTC = emtricitabine; PrEP = pre=exposure prophylaxis TDF = tenofovir disoproxil fumarate; TFV = tenofovir

References

  1. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22784037.
  2. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22784038.
  3. Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411-22. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22784040.
  4. Donnell D, Baeten JM, Bumpus NN, et al. HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acquir Immune Defic Syndr. 2014;66(3):340-348. Available at: https://www.ncbi.nlm.nih.gov/pubmed/24784763.

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