17 July 2012 

Truvada approved in the U.S. to help prevent HIV infection

Truvada is a fixed-dose combination of two anti-HIV drugs—tenofovir and FTC—in one tablet. Truvada has been widely used in North America, Western Europe and Australia as part of combination treatment for HIV. Now, Truvada has an additional use, at least in the U.S.

On Monday July 16, 2012, that country’s regulatory agency, the Food and Drug Administration (FDA), licensed Truvada for this use:

  • “To reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected patients.”

Using Truvada to reduce the risk of HIV infection is called pre-exposure prophylaxis, or PrEP.

Condoms still needed

According to the FDA, “Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes the following”:

  • HIV risk reduction counselling
  • consistent and correct use of condoms
  • regular HIV testing (at least every three months)
  • screening and treatment for sexually transmitted infections (STIs)

Furthermore, the FDA adds that “Truvada is not a substitute for safer sex practices.” This is because by itself Truvada is not 100% effective in preventing HIV infection.

When used as PrEP, Truvada must be taken every day in people who are confirmed to be HIV negative. The FDA warns that when used as PrEP, Truvada must not be prescribed to patients whose HIV status is unknown or who are HIV positive. The FDA encourages physicians to test their patients who use PrEP for HIV “at least every three months.”

Risk evaluation

According to the FDA, “Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of this REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.”

The everyday world of people’s lives

The studies that led to the approval of Truvada as PrEP were done in the carefully controlled setting of a randomized, placebo-controlled clinical trial. Participants were provided with regular prevention counselling, frequent testing for HIV and other STIs, free condoms, reminders about pill taking and other assistance to remain HIV negative. However, Truvada as PrEP needs to be assessed in the everyday world. To that end, and in collaboration with public health authorities in U.S. cities such as Miami and San Francisco, researchers are planning demonstration projects where Truvada will be freely distributed to several hundred people and its safety and effectiveness will be monitored.

Clinical trials

The decision to approve Truvada for PrEP was based primarily on the results of two clinical trials—iPrEX and Partners PrEP

In the iPrEX study, which involved 2,499 HIV-negative gay and bisexual men and transgender women, Truvada reduced the risk of HIV infection by 42% compared to fake Truvada (placebo).

In the Partners PrEP study, which involved 4,747 heterosexual couples where one partner was HIV positive, Truvada reduced the risk of HIV infection by 75% compared to placebo.

It should be noted that the use of Truvada for HIV prevention has also been studied in other clinical trials. One such study, called FEM-PrEP, which involved 2,120 HIV-negative women, was not able to demonstrate that Truvada was effective in reducing HIV transmission. Poor adherence may have been an important factor in this study. For more information about clinical trials of Truvada for PrEP, please see the resources at the end of this CATIE News article.

Side effects

Common side effects when Truvada is used as PrEP include the following:

  • headache
  • nausea
  • diarrhea
  • abdominal pain

PrEP guidance

The U.S. Centers for Disease Control and Prevention (CDC) is working with that country’s Public Health Service to develop comprehensive guidelines for the use of Truvada as PrEP. In the meantime, the CDC has developed interim guidance for health care providers when Truvada is used in gay and bisexual men and transgender women.

In Canada and other countries

Truvada is not approved in Canada or other countries for use as PrEP; it is approved as part of combination treatment for HIV. Truvada manufacturer Gilead Sciences is considering its options when seeking approval for Truvada as PrEP in Canada, Western Europe and Australia. In Canada, a month’s supply of Truvada (for HIV treatment) costs around $1,100, equivalent to $13,000 per year.


For more details about Truvada as PrEP and related issues, see the following CATIE resources:

                                                                                                                        —Sean R. Hosein


  1. Food and Drug Administration. Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus. HIV/AIDS Update. 16 July 2012.
  2. Padian NS, McCoy SI, Karim SS, et al. HIV prevention transformed: the new prevention research agenda. Lancet 2011;378:269-78.
  3. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. New England Journal of Medicine. 2012; in press.
  4. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. New England Journal of Medicine. 2012; in press.
  5. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine. 2012; in press.
  6. Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. New England Journal of Medicine. 2012; in press.
  7. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. New England Journal of Medicine. 2011;365:493-505.
  8. Cohen MS, Baden LR. Preexposure prophylaxis—where do we go from here? New England Journal of Medicine. 2012; in press.
  9. Hallett TB, Baeten JM, Heffron R, et al. Optimal uses of antiretrovirals for prevention in HIV-1 serodiscordant heterosexual couples in South Africa: a modeling study. PLoS Medicine. 2011;8(11):e1001123.
  10. Juusola JL, Brandeau ML, Owens DK, et al. The cost-effectiveness of preexposure prophylaxis for HIV prevention in the United States in men who have sex with men. Annals of Internal Medicine. 2012 Apr 17;156(8):541-50.
  11. Vastag B. FDA approves Truvada to prevent HIV infection. Washington Post. 16 July 2012. Available at: [subscription may be required]
  12. Grady D. Taking Truvada to prevent HIV also comes with risks. New York Times. 14 May 2012. Available at: [subscription may be required]