The first comprehensive CDC clinical practice guidelines for PrEP detail updated procedures for using HIV prophylaxis. Truvada (tenofovir disoproxil fumarate/emtricitabine), also referred to as TDF/FC, is the only drug approved by the FDA for this purpose. The HIV epidemic in the United States continues to grow, with approximately 50,000 new infections occurring annually. Preventing transmission of sexually acquired HIV-1 is therefore vital.
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Statistics from 2010 showed that 63% of the estimated 47,500 new infections were attributed to male-male sexual activity without injection drug use, 4% to male-male sexual activity with injection drug use, 25% to male-female sexual contact without injection drug use, and 8% to injection drug use. The figures showed the strong need for additional methods of HIV prevention to help prevent infection among those who are at higher risk.
Preexposure prophylaxis, or PrEP, can help those who do not have HIV protect themselves from an HIV infection. The PrEP combination pill contains two HIV medicines that can help stop the virus from establishing an infection. High adherence is key for effectiveness, so a strict routine of taking daily oral PrEP with the fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine is necessary. When using PrEP, patients should also be involved with other effective risk-reduction services and practices.
PrEP may be considered for individuals who are HIV-negative and at substantial risk for HIV infection. It is recommended as one HIV prevention option for sexually active men who have sex with men and are at substantial risk of HIV acquisition. Additionally, it is recommended for heterosexually active men and women, and for adult injection drug users, who have substantial risk of HIV acquisition. Heterosexually active women and men whose partners have HIV infection (i.e., HIV-discordant couples) should be educated on the benefits and risks of PrEP during conception and pregnancy, as one of several options to protect the partner who is HIV-negative. There currently is not sufficient data on the efficacy and safety of PrEP for adolescents. Individuals who have acute or chronic HIV infection are not eligible for PrEP treatment. The following table provides a summary of the clinical indications and treatment recommendations for PrEP that are included in the clinical practice guidelines from the CDC.
| Summary of Guidance for PrEP Use |
| | Men Who Have Sex with Men | Heterosexual Women and Men | Injection Drug Users |
| Detecting substantial risk of aquiring HIV infection | - HIV-positive sexual partner
- Recent bacterial STI
- High number of sex partners
- History of inconsistent or no condom use
- Commercial sex work
| - HIV-positive sexual partner
- Recent bacterial STI
- High number of sex partners
- History of inconsistent or no condom use
- Commercial sex work
- In high-prevalence area or network
| - HIV-positive injecting partner
- Sharing injection equipment
- Recent drug treatment (but currently injecting)
|
| Clinically eligible | - Documented negative HIV test result before prescribing PrEP
- No signs/symptoms of acute HIV infection
- Normal renal function; no contraindicated medications
- Documented hepatitis B virus infection and vaccination status
|
| Prescription | Daily, continuing, oral doses of TDF/FTC (Truvada), ≤90-day supply |
| Other services | Follow-up visits at least every 3 months to provide the following: - HIV test, medication adherence counseling, behavioral risk reduction support, side effect assessment, STI symptom assessment
- At 3 months and every 6 months thereafter, assess renal function
- Every 6 months, test for bacterial STIs
|
- Do oral/rectal STI testing
| - Assess pregnancy intent
- Pregnancy test every 3 months
| - Access to clean needles/syringes and drug treatment services
|
STI = sexually transmitted infection
Source: US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States — 2014: a clinical practice guideline. |
Studies conducted showed strong evidence supporting the use of PrEP.
- Among gay and bisexual men, those taking PrEP were 44% less likely to acquire HIV than those taking a placebo. When the men took the pill consistently, as evidenced by detectable levels of the drug in their blood, the risk of infection was improved by as much as 92%.
- The risk reduction was 62% among heterosexually active men and women.
- In heterosexual, HIV-discordant couples, those taking PrEP were 75% less likely to become infected than those who were on a placebo. When taken consistently, PrEP reduced the risk of HIV infection by up to 90% in these individuals.
- Among injection drug users, daily use of only tenofovir (one of the two drugs of PrEP) reduced the risk of HIV by 49%. Those injection drug users who were highly adherent to their therapy reduced their HIV infection risk by 74%.
Currently, Truvada is the only drug acknowledged as safe and effective by the FDA for prophylaxis. None of the PrEP studies found significant safety concerns with use of daily oral PrEP. Some participants in the trials did report mild side effects that usually resolved within a month. The safety of antiretroviral use to prevent HIV was confirmed in studies prior to the PrEP trials. The evidence from these human studies concluded that PrEP could reduce the risk of acquiring HIV infection from sexual and drug-use exposures, and the subsequent clinical trials were then launched and confirmed the safety and efficacy of PrEP in populations at risk of HIV infection.
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Salvatore Volpe, MD, FAAP, FACP, CHCQM
Chief Medical Officer
PDR