Aug. 26, 2024
PrEP, or pre-exposure prophylaxis, is medicine people at risk for HIV take to prevent getting HIV from sex or injection drug use. PrEP can stop HIV from taking hold and spreading throughout your body.
Currently, there are two FDA-approved daily oral medications for PrEP. A long-acting injectable form of PrEP has also been approved by the FDA.
PrEP is highly effective at preventing HIV when taken as indicated.
PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed. Among people who inject drugs, it reduces the risk by at least 74% when taken as prescribed. PrEP is much less effective when it isn't taken consistently.
PrEP may benefit you if you test negative for HIV and any of the following apply to you:
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You may choose to take PrEP even if the behaviors above don&#;t apply to you. Talk to your health care provider.
If you have a partner with HIV and are considering getting pregnant, talk to your doctor about PrEP. PrEP may be an option to help protect you and your baby from getting HIV while you try to get pregnant, during pregnancy, or while breastfeeding.
PrEP can be pills or shots.
There are two pills approved for daily use as PrEP. They are combinations of two anti-HIV drugs in a single pill:
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A long-acting injectable form of PrEP has also been approved by the FDA:
PrEP is safe. No significant health effects have been seen in people who are HIV-negative and have taken PrEP for up to 5 years.
Some people taking PrEP may have side effects, like nausea, diarrhea, headache, fatigue, and stomach pain. These side effects are usually not serious and go away over time. If you are taking PrEP, tell your health care provider if you have any side effect that bothers you or that does not go away.
And be aware: PrEP protects you against HIV but not against other sexually transmitted infections (STIs) or other types of infections. Combining PrEP with condoms will reduce your risk of getting other STIs.
If you think PrEP may be right for you, visit your doctor or health care provider. PrEP is only available by prescription. Any health care provider licensed to write prescriptions can prescribe PrEP; specialization in infectious diseases or HIV medicine is not required.
Because PrEP is for people who are HIV-negative, you&#;ll have to get an HIV test before starting PrEP and you may need to get other tests to make sure it&#;s safe for you to use PrEP.
If you take daily oral PrEP, you&#;ll need to see a health care provider every 3 months for repeat HIV tests, prescription refills, and follow-up. If you use injectable PrEP, you&#;ll need to see a healthcare provider every two months for an HIV test and the injections.
If you don&#;t have a health care provider:
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PrEP remains one of the strongest tools in the HIV prevention toolbox. There are a wide variety of efforts focused on supporting PrEP and other options where you can obtain PrEP medication and/or services. Use this decision tree to find out how to pay for PrEP.
In most cases, the cost of PrEP medication and services are covered by insurance.
Under the Affordable Care Act, PrEP is free under almost all health insurance plans. PrEP is a preventive service and should be covered without charging you a co-payment or co-insurance. This is true even if you haven&#;t met your yearly deductible. That means you can&#;t be charged for your PrEP medication, the clinic visits to see your health care provider, and lab tests you need to get and maintain your prescription. There are no out-of-pocket costs for you. Exit Disclaimer.
This applies to most private health insurance plans you get through your employer or purchase yourself, individual plans you purchase through HealthCare.gov or state-based Marketplaces, and state Medicaid expansion coverage plans, including the Basic Health Plans. In some states, the traditional Medicaid program also covers PrEP at no charge.[1] This does not automatically apply to Medicare. (Medicare Part D prescription drug plans cover PrEP medication, but there will still be cost sharing.)
To find out whether your health plan covers PrEP medications without charge:
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If you don&#;t have insurance or Medicaid coverage, there are resources that may be able to help you pay for PrEP and/or your necessary clinic visits and tests.
Related links:Goto Cohwa to know more.
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: California, Colorado, District of Columbia, Illinois, Indiana, Iowa, Massachusetts, New Mexico, Ohio, Oklahoma, and Washington have state-based programs to help people who have insurance to lower or eliminate the amount they owe as a co-payment for PrEP. These programs also support the costs of clinic visits and lab testing.Exit Disclaimer
: The Patient Advocate Foundation helps people who have insurance to lower or eliminate the amount they owe as a co-payment for PrEP.Exit Disclaimer
: California, Colorado, Florida, Indiana, Massachusetts, New Mexico, Oklahoma, Virginia, and Washington have state-based programs to help people who do not have insurance or whose insurance does not cover a specific medication to have access to the medication they need at no cost. These programs also support the costs of clinic visits and lab testing.If you think PrEP might be right for you, or you want to learn more, visit CDC&#;s PrEP Basics.
Also: watch and share KFF&#;s Greater Than HIV and CDC&#;s Let's Stop HIV Together Exit Disclaimer videos with PrEP Basics information and Exit Disclaimer. Also, their Exit Disclaimer feature real people sharing why they are taking PrEP to prevent HIV and how it has helped them take charge of their health.
Use the HIV Services Locator to find a PrEP provider and other HIV services near you.
[1] California, Colorado, District of Columbia, Delaware, Hawaii, Iowa, Kentucky, Louisiana, Massachusetts, Montana, Nevada, New Hampshire, New Jersey, Oregon, Washington, and Wisconsin. (Exit Disclaimer (PDF, 205 KB))
To update its recommendation statement, the USPSTF commissioned a systematic review15,32 of the evidence on the benefits and harms of PrEP with TDF/FTC, tenofovir disoproxil fumarate alone, the dapivirine vaginal ring, TAF/FTC, and injectable cabotegravir for the prevention of HIV acquisition, and the diagnostic accuracy of risk assessment tools to identify persons at increased risk of HIV acquisition.
The USPSTF found 12 studies that evaluated risk assessment tools developed in US cohorts for predicting incident HIV. Eight studies were conducted in men who have sex with men, 1 in persons who inject drugs, 1 in cisgender women, and 2 in the general population.15,32 Among the studies in men who have sex with men and persons who inject drugs that reported this measure, discrimination of the risk assessment tool was moderate, with an area under the receiver operating characteristic curve of 0.60 to 0.73.15,32 The 2 studies conducted in the general population evaluated 2 different risk assessment tools (number of items, 23 and 44) that used automated algorithms on electronic medical record data. These 2 studies reported moderate to high discrimination for incident HIV (area under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.79] and 0.84 [95% CI, 0.80-0.89]).33,34 One study focused on cisgender women who had a positive HIV test result. It found that a 6-item risk assessment tool, based on electronic medical record data, had sensitivity of 95% for incident HIV (21 cases).35
All these studies had some limitations. Most of the risk assessment tools were developed and validated using previously collected data (ie, not prospectively validated). The study of cisgender women focused only on persons with a new positive HIV test result; thus, only sensitivity but no other measures of test accuracy could be calculated. Additionally, it was based on a small number of incident cases. The feasibility of implementation of risk assessment tools based on automated algorithms of electronic medical record data are unknown. Last, some studies used cohorts from prior to , and several studies did not predefine the cutoff for a positive test result.15,32
The USPSTF found 17 trials that compared a variety of formulations of PrEP with placebo or PrEP with TDF/FTC. Twelve trials compared TDF/FTC or tenofovir disoproxil fumarate alone with placebo, 2 trials compared the dapivirine vaginal ring with placebo, 1 trial compared TAF/FTC with TDF/FTC, and 2 trials compared injectable cabotegravir with TDF/FTC.15,32
In the 12 trials of TDF/FTC or tenofovir disoproxil fumarate alone, duration of follow-up ranged from 4 months to 4 years. Six trials enrolled men and women at risk of acquiring HIV via heterosexual contact, 4 trials enrolled men who have sex with men or transgender women, 1 trial enrolled at-risk women and men who have sex with men, and 1 trial enrolled persons who inject drugs. No trial enrolled pregnant persons or persons younger than 18 years. Seven trials were conducted in Africa, 1 in Thailand, 2 in Europe or Canada, and 1 in the US; 1 trial was multinational. All trials of persons at risk of HIV acquisition via heterosexual contact were conducted in Africa. All trials included behavioral and adherence counseling, and most provided condoms to all trial participants.15,32
In a pooled analysis, TDF/FTC or tenofovir disoproxil fumarate alone was associated with significantly decreased risk of HIV acquisition vs placebo or no PrEP (11 trials [n = 18,172]; relative risk [RR], 0.46 [95% CI, 0.33-0.66]; absolute risk reduction, &#;2.0% [95% CI, &#;2.8% to &#;1.2%] after 4 months to 4 years).15,32
There was a strong association between degree of adherence (assessed in different studies by methods such as patient self-report, pill counts, adherence monitoring devices, plasma drug levels, and prescription fill data) and the effectiveness of oral PrEP (P < .001 for interaction). In 6 trials in which adherence was 70% or greater, the RR of HIV acquisition was 0.27 (95% CI, 0.19-0.39), in 3 trials in which adherence was greater than 40% to less than 70%, the RR was 0.51 (95% CI, 0.38-0.70), and in 2 trials in which adherence was 40% or less, oral PrEP was not associated with a decreased risk of HIV (RR, 0.93 [95% CI, 0.72-1.20]).15,32
Oral PrEP with TDF/FTC or tenofovir disoproxil fumarate alone was consistently associated with decreased risk of HIV acquisition vs placebo when trials were stratified according to HIV risk category (men who have sex with men, men and women at risk via heterosexual contact, or persons who inject drugs) or setting (highly developed or less highly developed countries).15,32 The effectiveness of tenofovir disoproxil fumarate alone (RR, 0.49 [95% CI, 0.28-0.84]) and TDF/FTC (RR, 0.44 [95% CI, 0.27-0.72]) were similar.15,32 All trials evaluated daily PrEP, except for 1 trial of event-driven PrEP (consisting of 2 tablets of TDF/FTC 2 to 24 hours before intercourse, followed by 1 tablet 24 hours and 48 hours after the first dose) in men who have sex with men. This trial found event-driven PrEP was associated with a significantly decreased risk of HIV acquisition compared with placebo (RR, 0.14 [95% CI, 0.03-0.63]),36 although in that trial, men randomly assigned to PrEP took an average of about 4 doses of PrEP per week, so it is uncertain whether this finding would apply to less-frequent use of event-driven dosing.
In a pooled analysis of 2 trials, the dapivirine vaginal ring was associated with decreased risk of HIV acquisition compared with a placebo ring in African women at risk of HIV (n = ; RR, 0.71 [95% CI, 0.57-0.89]).15,32 The absolute risk reduction was &#;2.23% (95% CI, &#;3.75% to &#;0.74%) at 1.4 to 1.6 years.15,32 Notably, the dapivirine vaginal ring is not approved by the FDA and is not available for use in the US.
One trial, DISCOVER (n = ), compared PrEP with oral TAF/FTC vs TDF/FTC. It was conducted in Europe and North America and enrolled HIV-negative cisgender adult men (98.6%) and transgender women (1.4%) who have sex with men and are at risk of HIV acquisition, based on having condomless anal intercourse with at least 2 partners in the previous 12 weeks or an STI (syphilis, rectal gonorrhea, or rectal chlamydia) in the previous 24 weeks. At 96 weeks, TAF/FTC was associated with a statistically nonsignificant decreased risk of HIV acquisition vs TDF/FTC (0.3% vs 0.6%; RR, 0.53 [95% CI, 0.23-1.26]); results were within the prespecified noninferiority margin (ie, TAF/FTC was noninferior to TDF/FTC).37,38
Two trials (HIV Prevention Trials Network [HPTN] trials 083 and 084) compared long-acting injectable cabotegravir (600 mg intramuscularly every 8 weeks, following a 5-week oral lead-in phase of 30 mg daily) vs daily oral TDF/FTC.39,40 In HPTN 083 (n = ), 87% of participants were men who have sex with men and 12% were transgender women who have sex with men. Among US participants (37% of total participants), 50% were Black. At median follow-up of 1.4 years, injectable cabotegravir was associated with a significantly decreased risk of HIV acquisition vs oral TDF/FTC (0.6% vs 1.7%; RR, 0.33 [95% CI, 0.18-0.62]). In stratified analysis, results were similar in men who have sex with men (hazard ratio, 0.35 [95% CI, 0.18-0.68]) and transgender women (hazard ratio, 0.34 [95% CI, 0.08-1.56]), although the estimate for transgender women was imprecise.39 HPTN 084 (n = ) was conducted in 7 countries in sub-Saharan Africa. Participants were female (sex assigned at birth), were aged 18 to 45 years (median, 25 years), reported engaging in vaginal intercourse in the prior 30 days, and were assessed as being at risk for HIV acquisition using a risk prediction instrument developed and validated in African women. At median follow-up of 1.2 years, injectable cabotegravir was associated with a significantly decreased risk of HIV acquisition vs oral TDF/FTC (0.3% vs 2.3%; RR, 0.11 [95% CI, 0.04-0.31]).40
The trials that investigated the effectiveness of PrEP also reported on harms. Oral PrEP with TDF/FTC or tenofovir disoproxil fumarate alone was associated with increased risk of kidney adverse events (primarily grade 1 or higher creatinine level elevation) (12 trials [n = 18,170]; RR, 1.43 [95% CI, 1.18-1.75]; absolute risk difference, 0.56% [95% CI, 0.09%-1.04%]). Kidney abnormalities generally resolved following PrEP cessation. Oral PrEP with TDF/FTC or tenofovir disoproxil fumarate alone was associated with increased risk of gastrointestinal adverse events (12 trials [n = 18,300]; RR, 1.63 [95% CI, 1.26-2.11]; absolute risk difference, 1.95% [95% CI, 0.48%-3.43%]), which were generally not serious and diminished over time. TDF/FTC and tenofovir disoproxil fumarate alone were associated with a statistically nonsignificant increased risk of fracture vs placebo (7 trials [n = 15,241]; RR, 1.23 [95% CI, 0.97-1.56]); this outcome was heavily weighted by 1 trial conducted in persons who inject drugs.15,32
One trial (n = ) reported no differences between TAF/FTC and TDF/FTC in rates of any kidney adverse events (1% vs 1%) or risk of fracture (2% vs 2%).38 Two trials (n = ) reported no differences between long-acting injectable cabotegravir and TDF/FTC in risk of decreased creatinine clearance or elevations in alanine aminotransferase or aspartate aminotransferase levels. Cabotegravir was associated with increased weight gain compared with TDF/FTC (mean differences, 0.86 and 0.4 kg) and increased risk of injection site reactions (most commonly pain) that were usually mild.39,40
One concern about PrEP is that its use may lead to persons at risk of HIV acquisition not using condoms or engaging in other behaviors that could increase their risk of STIs (ie, behavioral risk compensation). In pooled analyses of randomized trials, there were no differences between PrEP with TDF/FTC or tenofovir disoproxil fumarate alone and placebo in risk of syphilis (4 trials [n = 10,775]; RR, 1.08 [95% CI, 0.98-1.18]), gonorrhea (5 trials; RR, 1.07 [95% CI, 0.82-1.39]), chlamydia (5 trials; RR, 0.97 [95% CI, 0.80-1.18]), or combined bacterial STIs (2 trials; RR, 1.14 [95% CI, 0.97-1.34]),15,32 although all trials except for 1 were blinded, which could affect risk of STIs if participants who do not know whether they are taking PrEP or placebo behave differently than those who know they are taking PrEP. In the 1 open-label trial, there was also no statistically significant association between PrEP and the risk of STIs, although estimates were imprecise.41 Two trials of the dapivirine vaginal ring42,43 also reported no differences in risk of STIs vs placebo.
An additional concern is the possibility that the use of antiretroviral drugs as PrEP could lead to the development or acquisition of drug-resistant HIV. Among all patients randomized to oral PrEP with TDF/FTC or tenofovir disoproxil fumarate alone, 2 of patients taking tenofovir disoproxil fumarate alone (0.06%) (4 trials) and 14 of patients taking TDF/FTC (0.3%) (7 trials) were identified as having incident HIV with a drug resistance variant.15,32 Most resistance variants occurred in persons who already had HIV on trial enrollment but were not recognized as such, highlighting the importance of testing for HIV and excluding persons with HIV before initiating PrEP. In 5 observational studies of PrEP with TDF/FTC, 2 of participants (0.1%) were diagnosed with an antiretroviral drug resistance variant.15,32 In the DISCOVER trial (n = ), among 20 patients who tested positive for HIV and had resistance testing results, an emtricitabine resistance variant was detected in 4 patients. All cases occurred in patients randomized to TDF/FTC who were suspected of having HIV at baseline.37
In 2 trials of the dapivirine (a nonnucleoside reverse transcriptase inhibitor [NNRTI]) vaginal ring, the proportion of patients randomized to dapivirine with an NNRTI resistance variant was 0.8% (22/). In both trials, the rate of NNRTI resistance variants among patients with incident HIV was similar in patients randomized to the dapivirine vaginal ring vs those randomized to placebo (11.8% [8/68] vs 10.4% [10/96]; P = . and 18.2% [14/77] vs 16.1% [9/56]; P = .75).43
In the HPTN 083 and HPTN 084 trials, which compared cabotegravir (an integrase strand transfer inhibitor [INSTI]) with TDF/FTC, among all patients randomized to cabotegravir, the proportion with an INSTI resistance variant was 0.1% (4/), although only 13 of 17 individuals with incident HIV across both trials underwent resistance testing. Among individuals randomized to TDF/FTC across both trials, the proportion found to have antiretroviral resistance variants was also 0.1% (5/).39,40
Evidence on the effect of acquiring antiretroviral-resistant HIV on clinical outcomes is very limited. One study reported that among 5 patients previously exposed to PrEP and diagnosed with HIV with an M184V or M184I (emtricitabine) variant, 4 had an undetectable viral load 3 months after starting antiretroviral therapy and 1 patient was lost to follow-up.44 Another study included 52 persons diagnosed with HIV who reported recent PrEP exposure. All 39 individuals with a viral load greater than 200 copies/mL at baseline who received antiretroviral therapy achieved an undetectable viral load at 24 weeks. Results were not reported separately for patients with an antiretroviral resistance variant.45
No trials of PrEP enrolled persons who were pregnant. However, among persons who became pregnant, a pooled analysis of 3 trials of TDF/FTC or tenofovir disoproxil fumarate alone found that PrEP was not associated with increased risk of spontaneous abortion (3 trials [n = 415]; RR, 1.09 [95% CI, 0.79-1.50]).15,32 One trial found no differences between TDF/FTC or tenofovir disoproxil fumarate alone and placebo in pregnancy rate, risk of preterm birth, congenital anomalies, or postpartum infant mortality.46 There were no differences between the dapivirine vaginal ring and placebo in incidence of pregnancy.42,43 In 1 trial of cabotegravir enrolling female participants, pregnancy incidence was low with both cabotegravir and TDF/FTC, and no congenital abnormalities were observed.40
A draft version of this recommendation statement was posted for public comment on the USPSTF website from December 13, , to January 17, . Most comments were supportive of the USPSTF recommendation. Comments suggested that alternate wording for the term HIV infection be used. The USPSTF is committed to the use of nonstigmatizing and inclusive language, and in response removed the word &#;infection&#; from its recommendation. The USPSTF agrees with comments that adherence support is an important component of providing PrEP and notes this in the Implementation section. In response to public comment, the USPSTF clarified that persons who request PrEP may have undisclosed behaviors that put them at risk of HIV acquisition. The USPSTF also added detail about considerations when discontinuing cabotegravir to the Implementation section. Last, the USPSTF clarified that gender-diverse persons are among the included individuals for the research gap on the need for accurate and validated risk assessment tools.
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