Truvada for PrEP
emtricitabine/tenofovir DF (FTC/TDF)
Standard DoseFor HIV-negative adults and adolescents weighing at least 77 pounds (35 kg), one tablet once daily, without regard to food. The tablet contains 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate.
Take a missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Truvada should not be used for prevention if eCrCl or eGFR (measures of kidney function) is less than 60 mL/min.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
Potential Side Effects and Toxicity
No new serious side effects were seen when Truvada was studied for HIV prevention in clinical trials. Some patients may experience nausea, headache, stomach pain, or weight loss. Risk compensation (when people put themselves at greater risk for infection, such as anonymous or multiple sex partners, because they think PrEP will protect them) was not observed in clinical trials. The tenofovir DF (Viread) in Truvada is associated with long-term decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of bone fracture due to a disease or are at risk for osteopenia or osteoporosis. Truvada can cause kidney toxicities. In prevention studies, decreases in BMD and creatinine clearance or eGFR (a marker of kidney function) were rare, mild, and reversible upon stopping Truvada. Tell your provider about pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits as these could be signs of kidney or bone problems. If Truvada is discontinued abruptly in people with hepatitis B virus (HBV), flare-up of hepatitis may occur—talk to your provider before discontinuing. In studies, there were cases of people who had unidentified HIV infection when starting Truvada for PrEP and subsequently developed drug resistance. A negative HIV test must be confirmed immediately prior to starting Truvada for PrEP. Truvada alone is not a complete regimen to treat HIV. Continuing only with Truvada after acquiring HIV may lead to drug resistance and limit future antiviral options. Truvada contains lactose, which can cause some abdominal discomfort, especially in patients sensitive to lactose.
- See the individual drugs contained in Truvada: Viread and Emtriva
- See package insert for more complete information on potential side effects and interactions.
Potential Drug Interactions
Do not take with any other HIV or HBV drugs when used for PrEP. Avoid taking Truvada with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain like Advil or Motrin (ibuprofen) and Aleve (naproxen). Truvada for PreP can be used with the hepatitis C drugs Daklinza, Harvoni, Sovaldi, Olysio, Viekira Pak, or Zepatier. Monitor for tenofovir toxicities if used with Epclusa. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not.
Let’s be clear: Truvada for PrEP is almost 100% effective in preventing HIV—this is a done deal. Why aren’t more people using it to help end the epidemic? Stigma and lack of access to health care continue to fuel HIV infections. Remember, risk depends on the situation—including where you live or how much money your friends have or some such. Stigma—not sex—is the real shame. Other problems include not knowing about PrEP and inability to perceive a need for it (not realizing one may be vulnerable at all). Altogether, even doctors continue to avoid prescribing PrEP. Although PrEP should become medically routine, like HIV tests for pregnant women, until it is, we’ll tell you again: seeing an HIV specialist is the best way to obtain PrEP. They get it. It’s not about being a whore. And better yet, they care. Fortunately, new avenues for PrEP—many without HIV specialty—are opening up: pharmacist-led PrEP clinics, tele-PrEP (via video consultation), use of ERs and STD clinics, and so on. As for “just use a condom,” there are many reasons why condoms are not enough. So can we move on?
Truvada, a widely-used medication for the treatment of HIV, was approved in July 2012 by the Food and Drug Administration (FDA) to reduce the risk of HIV infection in HIV-negative individuals ”at risk” for HIV acquisition (according to the drug label – in reality, people rarely realize that they’re at risk for HIV at all). Although the drug label specifies sexually-acquired infection, U.S. HIV guidelines also recommend use for protecting against infection through injection drug use (reducing the risk of HIV by more than 70%, according to the CDC). This approach to HIV prevention is called pre-exposure prophylaxis, or PrEP (“prophylaxis” means something that prevents disease, such as a condom or a vaccine). The U.S. Public Health Service (USPHS) has issued updated guidelines for the use of Truvada for PrEP. Go to cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Truvada is currently the only drug approved for PrEP.
There are many considerations regarding Truvada for PrEP. Proper use is crucial. It is vital that people test HIV-negative right before being given a prescription (the label says “immediately,” the CDC says within 7 days). Patients should also be re-tested for HIV infection at least every three months while taking Truvada for PrEP. People who are already unknowingly HIV infected when starting PrEP risk developing drug-resistant virus because Truvada alone is not adequate for the treatment of HIV. Drug resistance can only occur in HIV-positive individuals. Truvada for PrEP should not be given to people with symptoms of recent (acute) infection, such as fever, fatigue, sweating a lot (especially at night), rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, or enlarged lymph nodes (especially in the neck or groin). PrEP should not be started (or re-started) if any of these symptoms appear after a potential exposure to HIV unless evaluated by a doctor and possibly re-tested for HIV. People on PrEP who have these symptoms after a potential exposure to HIV should let their provider know immediately.
Truvada for PrEP is not a “morning-after pill” or a weekend medication. It must be taken every day to be maximally effective. In studies, greater protection was seen with greater adherence. Truvada for PrEP works if you take it as prescribed. On the other hand, there have been good results with using it around the time of sex (kudos to the IPERGAY study)—the research continues. Unlike HIV therapy, which is long-term, PrEP may be used just for periods of time when HIV-negative individuals are most vulnerable to infection.
While some people may use PrEP as their only prevention method, it was studied and approved as part of a more comprehensive HIV prevention strategy that includes the use of condoms and risk reduction counseling. That said, the CDC has changed the definition of protected sex to include sex without condoms, given new modalities such as PrEP. Although consistent condom use is an important part of a prevention plan for all people prescribed PrEP, lack of use of a barrier protection is not a reason to withhold PrEP. On the contrary, the PrEP label lists people who are unwilling or unable to use condoms as at-risk candidates for whom the drug is indicated. PrEP does not protect against other sexually transmitted infections (STDs) including hepatitis C or against pregnancy.
Other screening and monitoring requirements include measuring kidney function and checking for STIs and hepatitis B and C, treatment for STIs, and vaccination for HBV if warranted.
Although a PrEP prescription can be given to a wide range of people, the Truvada PrEP drug label states that it is indicated for those considered “at risk” for infection. The label notes that people at risk include those who engage in sexual activity in a high-prevalence area or social network and have one or more of the following: (a) inconsistent or no condom use, (b) diagnosis of sexually transmitted infections (STIs), (c) exchange of sex for commodities (money, food, shelter, or drugs), (d) use of illicit drugs or alcohol dependence, (e) history of incarceration, or (f) sexual partners of unknown HIV status with any of the above risk factors. U.S. HIV treatment guidelines state that, “Truvada has been shown to be safe and effective at preventing HIV in healthy adults who meet recommended criteria in the following populations: MSM [men who have sex with men], heterosexually active men and women, and IV drug users.”
Individuals who have used post-exposure prophylaxis (PEP) multiple times are also good candidates for PrEP because of their continuing risk for HIV. PEP is a course of HIV medications taken for 28 days after exposure to HIV to prevent infection; it must be started as soon as possible but no later than 72 hours after exposure.
Although pregnant women were not enrolled in PrEP studies, there is hope for PrEP to help serodiscordant couples (where one partner is positive and one is negative) conceive without transmitting the virus. Last year, the DHHS perinatal HIV guidelines added a section on the use of PrEP and HIV therapy to prevent transmission in sero-different couples trying to conceive; go to aidsinfo.nih.gov. The Bay Area Perinatal AIDS Center (BAPAC) is leading the charge for safer conception options, including MSM, plus a new providers list at pleaseprepme.org; go to hiveonline.org.
According to the World Health Organization, it takes Truvada for PrEP 7 days to reach protective levels, whether exposure is rectal or vaginal. The CDC notes time to steady state, or maximum intracellular concentrations of tenofovir diphospate (TFV-DP), of 7 days for the rectal tract and about 20 days for vaginal tissue. Protective levels, however, are reached much earlier, based on pharmacokinetic (PK) models.
The two studies that led to Truvada’s approval for PrEP, iPrEx (in high-risk MSM and transgender women) and Partners PrEP (in serodiscordant couples, most of them heterosexual), showed efficacy rates between 90%–92% when participants take their meds. PrEP with Truvada has also been studied in other patient populations, including younger single men and women, injection drug users, and women. In all the studies, the common theme is that PrEP is effective if you take it every day. Other drugs are being studied for use as HIV PrEP, including long-acting injection formulations requiring only one injection every 4–8 weeks.
Some providers not working in HIV are still learning about PrEP, and some continue to be reluctant to prescribe it. Read the PDF of the CDC brochure “Talk to Your Doctor about PrEP.” The brochure includes resources for providers. HIV specialists may be best for a PEP or PrEP prescription, as they are familiar with the medications and more supportive of PrEP; find providers at hivma.org and aahivm.org, as well as pleaseprepme.org. HIV specialists are generally in high demand, however, and advocates are looking to make Truvada for PrEP much more accessible. There is also a complex set of standards to use in prescribing PrEP that may cause many providers to turn away, including a call for safer sex counseling. As of July 1, 2019, however, the FDA no longer requires a REMS (Risk Evaluation and Mitigation Strategy) program for Truvada for PrEP. The National Alliance of State and Territorial AIDS Directors (NASTAD) developed a guide to help providers bill for PrEP services available at nastad.org/resource/billing-coding-guide-hiv-prevention. Two excellent websites for finding a PrEP provider are preplocator.org and aidsvu.org. All you need to do is enter your ZIP code, and a list of providers who prescribe Truvada for PrEP will appear.
Greater PrEP acceptance and use, however, appears to be increasing among communities most vulnerable to HIV. Health departments across the country are promoting PrEP as part of a strategy to end the HIV epidemic. In addition, prevention efforts are also focusing on U=U (Undetectable equals Untransmittable), promoting the awareness that people living with HIV who have undetectable viral loads do not transmit the virus to sexual partners. Go to preventionaccess.org.
Providers are reporting widespread acceptance of PrEP prescriptions by insurers. Gilead Sciences helps patients work with their insurance, including pre-authorizations, as well as provides free PrEP to uninsured patients who are eligible and co-pay assistance up to $4,800 a year; contact the patient assistance hotline at (855) 330-5479, or go to gileadadvancingaccess.com. Patients may also need to advocate on their own behalf; keeping good notes of conversations and other communication is a good idea. Also, check out prep4love.com.
PrEP Facts: Rethinking HIV Prevention and Sex is a closed Facebook group for people interested in or currently on PrEP, and their allies. Demonstration projects providing free PrEP to study its use in the real world can be found at PrEPWatch.org from AVAC and projectinform.org/prep. Providers can use V107 as a medical billing code for PrEP (exposure to infectious disease, including HIV).
Other information sources:
Robert Grant, MD, principal investigator for the iPrEx study, wrote in an article for Positively Aware, “The combination of highly active antiretroviral interventions for both HIV prevention and treatment has led to unprecedented optimism about the prospect of ending AIDS.”
Read Positively Aware’s special issues on PrEP: positivelyaware.com/issues/prep-issue-
Dr. David Hardy says:
Truvada was FDA approved as the first antiretroviral for pre-exposure prophylaxis (PrEP) for HIV in July 2012 based upon a very robust package of placebo-controlled randomized clinical trials among MSM and TGW (iPrEX study); serodiscordant, heterosexual couples (Partners PrEP study); single, heterosexual couples (TDF-2 study); and male and female injection drug users (Bangkok Tenofovir study). While its uptake was initially slow in the U.S., a significant increase in Truvada for PrEP prescriptions has been seen since 2016 with an estimated 220,000 to 250,000 persons receiving PrEP in the U.S. (PrEPWatch, August 2018; prepwatch.org/country/united-states, accessed January 14, 2019). However, several reports from HIV conferences have focused on the disproportionate high uptake among white MSM but low uptake among black and Hispanic MSM, and cis-gender, heterosexual, and transgender women (natap.org/2018/CROI/croi_196.htm). A report at the IAS 2018 conference from the CDC, Emory University, and Gilead showed a significant decline in newly diagnosed PLWH in areas of the U.S. where PrEP uptake was the highest (poz.com/article/rising-prep-use-associated-declining-hiv-diagnoses-united-states). Also, of note, the approval of Truvada for PrEP was extended to smaller and (most likely) younger persons at-risk for HIV as the FDA approved the use of Truvada for PrEP in persons weighing at least 35 kilograms or 77 pounds in May of 2018. With the availability of the generic, near-equivalent, and less costly Cimduo (tenfovir DF/lamivudine; see that page), the use of this antiretroviral for PrEP is a growing possibility. Regulatory-wise and according to the FDA, Cimduo is not officially approved for PrEP, only for treatment of HIV. Will this distinction matter when it comes time to spend less money and increase access to PrEP?
Activist Moisés Agosto-Rosario says:
PrEP is short for pre-exposure prophylaxis, which means protecting yourself from exposure to the HIV virus. Truvada is an HIV drug that has proven to reduce the risk of getting infected with HIV through sex. It is prescribed to be taken once a day, every day. Adherence is very important for PrEP to work. You have to be tested before using Truvada for PrEP and every three months see your health care provider who will test you for HIV and other sexually transmitted diseases (STDs). Truvada for PrEP does not reduce the risk for contracting STDs; that’s why it is strongly recommended to practice safer sex practices even if you take Truvada for PrEP. Truvada can cause serious adverse events like kidney damage and bone density loss. You should be monitored for both. Liver damage might occur, so it is important to check your liver enzymes.