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 CrCl 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. In adolescents, however, BMD-z scores (which compare bone growth to that of matched peers) did not return to baseline.
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 bone or kidney 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. When taken for HIV treatment, tenofovir may be associated with weight gain; see Truvada page.
Potential Drug Interactions
Do not take with any other HIV or HBV drugs (including Vemlidy, or TAF) when using Truvada 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.
In December, DHHS perinatal guidelines added a new section on PrEP for periconception, antepartum, and postpartum periods. A new PrEP drug was approved in October 2019—see Descovy for PrEP page. Truvada for PrEP is almost 100% effective in preventing HIV when taken daily as recommended. 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 have vulnerabilities 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 risk includes a number of behavioral, biological, or epidemiological factors, including condomless sex, current or past STIs, self-identified risk, having sexual partners of unknown HIV status or unknown HIV viremic status, or sexual activity in a high prevalence area or network. 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.
Truvada generic became available in the U.S. in October 2020. See discussion online of the generic’s pricing. 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. Melanie Thompson:
Approved in 2012 for HIV prevention, Truvada is up to 99% effective at preventing new HIV infections when taken daily with high adherence. Studies also indicate that intermittent treatment (2 doses within 12 hours prior to sex, and one dose on each of the following 2 days) can be effective, although this strategy has not been studied in, and is not recommended for, cis-gender women.
Truvada is currently the only approved drug for PrEP in cis-gender women.
The same side effects seen in treatment have been seen in the prevention setting, with a small decline in bone density and a small decline in kidney function. From the DISCOVER trial, we learned that lipids and weight are also slightly lower than for Descovy.
It should be noted that generic TDF/3TC (Cimduo/Temixys) can be substituted for treatment but has not yet been studied as PrEP. However, generic TDF/FTC from Teva can be substituted for Truvada. The cost is only slightly lower than branded Truvada, but Teva provides a co-pay card to help with out-of-pocket costs.
Activist Bridgette Picou:
Truvada as PrEP is taken once daily. Adherence is important with PrEP. Missed doses decrease effectiveness, thereby increasing the chance of seroconverting. The TDF (disoproxil fumarate) requires monitoring for kidney toxicity and bone density. These effects build up over time, so the longer you are on therapy, the more important it is. Testing for STIs will also be done at three-month intervals, when it’s time for your 90-day refill. Truvada can be used for all groups of people at risk of acquiring HIV whether engaging in vaginal or anal sex.