Pre-exposure prophylaxis for HIV prevention
Pre-exposure prophylaxis for HIV prevention, commonly known as PrEP, is the use of antiviral drugs as a strategy for the prevention of HIV/AIDS by people that do not have HIV/AIDS. PrEP is one of a number of HIV prevention strategies for people who are HIV-negative but who have a higher risk of acquiring HIV, including sexually active adults who are at increased risk of contracting HIV, people who engage in intravenous drug use, and serodiscordant sexually active couples.
The first form of PrEP for HIV prevention—emtricitabine and tenofovir disoproxil —was approved in 2012. In October 2019, the US Food and Drug Administration approved the combination of emtricitabine and tenofovir alafenamide to be used as PrEP in addition to Truvada, which provides similar levels of protection. Descovy, however, is currently approved only for cisgender males and transgender women as the efficacy has not been assessed in people at risk for HIV through receptive vaginal sex.
In December 2021, the US FDA approved cabotegravir, which is an injectable form of PrEP manufactured by Viiv Healthcare. Regulators believe it will improve medication adherence because it has to be taken just once every two months, and it will also widen adoption as it eliminates the need to hide pills or pharmacy visits for discretion.
In its 2021 guidelines, the World Health Organization recommends several options for PrEP, tailored to different populations and circumstances:
- Oral PrEP using TDF-containing compounds for anyone at substantial risk of HIV infection;
- Event-driven PrEP for men who have sex with men ; and
- The dapivirine vaginal ring for women at substantial risk of HIV infection who do not have access to oral PrEP.
Medical uses
Indications for use
United States
In the United States, federal guidelines updated in 2021 now recommend healthcare providers discuss and provide information on the use of PrEP for HIV prevention for all sexually active adults and adolescents. The US Centers for Disease Control and Prevention recommends providers take a targeted sexual history of their patients to assess specific risk for HIV acquisition and suggest PrEP to the following patients:- Sexually active adults and adolescents who have had anal or vaginal sex in the past six months and any of the following:
- * One or more partner with unknown HIV status and inconsistent condom use;
- * An HIV-positive sexual partner ;
- * A bacterial sexually transmitted infection in the past six months.
- Patients reporting injection drug use within the last six months and any of the following:
- * An HIV-positive injecting partner;
- * Shared injection equipment.
United Kingdom
In the United Kingdom the BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis 2018 recommend:- On-demand or daily oral tenofovir–emtricitabine for HIV-negative MSM who are at elevated risk of HIV acquisition through unprotected anal sex in the previous six months and ongoing unprotected anal sex.
- On-demand or daily oral TD-FTC for HIV-negative MSM having unprotected anal sex with partners who are HIV-positive, unless the partner has been on AntiRetroviral Therapy for at least six months and their plasma viral load is <200 copies/mL.
- Tenofovir alone should not be offered to MSM.
- Daily oral TD-FTC for HIV-negative heterosexual men and women having unprotected sex with partners who are HIV-positive, unless the partner has been on ART for at least six months and their plasma viral load is <200 copies/mL.
- Daily oral TD-FTC for heterosexual men and women on a case-by-case basis with current factors that may put them at increased risk of HIV acquisition.
- TDF alone can be offered to heterosexual men and women where FTC is contraindicated.
- PrEP is not recommended for people who inject drugs where needle exchange and opiate substitution programs are available and accessed by the individual.
- PrEP with daily oral TD-FTC for HIV-negative trans women who are at risk of HIV acquisition through unprotected anal sex in the previous six months and ongoing unprotected sex.
- Daily oral TD-FTC for HIV-negative trans women and trans men who have unprotected sex with partners who are HIV-positive, unless the partner has been on ART for at least six months and their plasma viral load is <200 copies/mL.
Other countries
Eligibility, follow-up care, dosage
Per WHO guidelines, initiation of PrEP can be done if a person tests negative for HIV, has no signs of current HIV infection, has good kidney function and no contraindications to the medication. Once PrEP is initiated, individuals are asked to see their healthcare provider at least every three to six months. During those visits, providers should repeat testing for HIV, test for other sexually transmitted infections, monitor kidney function, and/or test for pregnancy. Individuals must test negative for HIV prior to PrEP initiation because persons infected with HIV taking PrEP medication are at risk for becoming resistant to emtricitabine. Consequently, people with HIV infection and resistance to emtricitabine will have fewer options for selecting HIV treatment medications.Oral PrEP is typically taken daily following potential exposure. The CDC recommends follow-up visits at least every three months to provide HIV tests, medication adherence counseling, behavioral risk reduction support, side effect assessment, STI symptom assessment, and STI testing for sexually active individuals with symptoms of a current infection. Pregnancy tests should also be done every three months for woman who may become pregnant. At three months and every six months thereafter, renal function and presence of bacterial STI is assessed. Effectiveness of PrEP is associated with adherence, meaning the more consistently a person takes the medication as prescribed the greater the chance at reducing their risk for HIV.
There are two injection-based PrEP methods, with different drugs, one using lenacapavir and one with cabotegravir, each with guidelines for eligibility and initiation criteria similar to those of oral PrEP medications. However, instead of daily dosing, doses are one to six months apart. Lenacapavir is injected every six months; for initiation, in addition to injection, the same drug is also taken orally at the time of injection and one day later, as a loading dose. People who use cabotegravir receive the initial dose followed by a second dose one month later; thereafter dosing is every two months. As for all HIV PrEP, follow-up testing includes repeat HIV testing and STI screening. Those who decide to discontinue injectable PrEP may begin using oral PrEP one dosing period after their last injection.
PrEP has been shown to be effective at reducing the risk of acquiring HIV in individuals at increased risk. Studies evaluating PrEP efficacy to reduce risk of HIV infection found a linear relationship between adherence and effectiveness of medication. This means that the more closely people follow recommended dosing of PrEP, the more effective the medication is at preventing infection. However, PrEP is not 100% effective at preventing HIV, even in people who take the medication as prescribed. There have been several reported cases of people who acquired HIV despite taking PrEP. People taking PrEP may use combination prevention strategies along with PrEP, such as condoms and other protective barriers methods. If someone on PrEP acquires HIV, they may experience the signs and symptoms of HIV/AIDS.