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, for the prevention of HIV. 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.
See the individual drugs contained in Truvada: Viread and Emtriva
See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
Potential Side Effects and Toxicity
No new serious side effects were observed 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 usually 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.
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.
A new PrEP drug was approved in October 2019—see Descovy for PrEP page. Truvada for PrEP is almost 100% effective in preventing HIV. Stigma and lack of access to health care continue to fuel HIV infections. Remember, risk depends on the situation—including where you live. Other problems include not knowing about PrEP and inability to perceive a need for it (not realizing one may be vulnerable at all). Although the drug label specifies prevention of 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). 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. Screening and monitoring requirements include checking for STIs and hepatitis B and C.
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—although any provider can prescribe PrEP. 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 $7,200 a year; contact the patient assistance hotline at (877) 505-6986, or go to gileadadvancingaccess.com. PrEP Facts: Rethinking HIV Prevention and Sex is a closed Facebook group for people interested in or currently on PrEP, and their allies. For more information, go to cdc.gov/hiv/basics/prep.html.
Dr. Ross Slotten says:
“PrEP” stands for pre-exposure prophylaxis against HIV. It has become one of the two cornerstones of HIV eradication, the other being anti-HIV therapy itself. Public health authorities estimate that there are 1.2 million people at risk of HIV in the United States, but less than 100,000 people are taking PrEP. Truvada and Descovy are similar drugs manufactured by Gilead Sciences, Inc. The difference is that Truvada contains tenofovir disoproxil fumarate (TDF) and Descovy, tenofovir alafenamide (TAF). In healthy individuals at risk for HIV, Truvada and Descovy are very safe and the benefits far outweigh the risks. In a 4-year follow up of 10,343 individuals on a TDF-containing regimen, serious events occurred in 0.5% of that cohort. In 2.2% of study subjects, serum creatinine levels increased by 0.5 mg/dL (an increase considered to be significant). There are few long-term safety data for TAF containing regimens, although 4/10 patients in one study who were switched from TDF to TAF showed improvement in kidney function. People most at risk for side effects are those who are elderly, have a low body weight, have underlying kidney disease before starting medication or are diabetic, have uncontrolled high blood pressure, or are co-infected with hepatitis C. The bottom line is that for most people PrEP is safe, effective, and easy to take. Careful monitoring of kidney function will pick up problems before they become irreversible. Both drugs are well tolerated. If taken daily, they are 92–99% effective at preventing HIV. Both Truvada and Descovy take 7 days to become fully protective [for anal sex; 21 days for receptive vaginal sex]. It is therefore not recommended to skip doses or take the medication in an unconventional way, like one day before an unsafe sexual contact and a few days afterward, as some have advocated. I don’t believe there’s solid scientific evidence to back them up yet. If you want to stop PrEP, you should continue to take it for four weeks after the last [condomless] sexual contact. And neither Truvada nor Descovy protects against other sexually transmitted infections. In the pipeline are a good number of other possible PrEP candidates, including injectable agents, medication implants, vaginal rings embedded with a PrEP agent, etc.
Activist Bridgette Picou says:
Approved in 2012, Truvada for PrEP was a welcome addition in the fight against HIV. PrEP is pre-exposure prophylaxis. Taken once daily, the simple dosing offers 92- 99% effectiveness. It is mostly well tolerated with the most common complaints being stomach upset and headache. Current guidelines call for three month interval testing for HIV status, STIs, and kidney and liver function. Truvada has been known to cause loss of bone density and kidney toxicity, so keep an eye on that with your healthcare provider. Unlike Descovy, Truvada is indicated for all groups of people at risk for HIV including MSM, people who are transgender, and those who have receptive vaginal sex. While taking PrEP remember to take it each day as directed.