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 people 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 people who are sensitive to lactose. Truvada for PrEP may cause some weight loss.
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.
Truvada for PrEP is 99% 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 for hepatitis B and C. Insurers must now cover PrEP and its associated services (such as STI testing) without cost to people (such as co-pays), but the details of coverage can vary. This is as a result of the Grade A recommendation from the U.S. Preventative Services Task Force (USPSTF). 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 people work with their insurance, including pre-authorizations, as well as provides free PrEP to uninsured people who are eligible, and co-pay assistance up to $7,200 a year; contact the patient assistance hotline 24/7 at (877) 505-6986, or go to gileadadvancingaccess.com. On-demand PrEP with Truvada, which uses four tablets around the time of sex, is supported by guidelines from the International AIDS Society-USA, the European AIDS Clinical Society (EACS), and the World Health Organization. Truvada generic became available in the U.S. in October 2020. See discussion online of the generic’s pricing (positivelyaware.com/articles/briefly-novdec-2020 and positivelyaware.com/articles/briefly-jul-aug-2017). DHHS HIV guidelines have a section on using PrEP for periconception, antepartum, and postpartum periods. 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. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
Truvada was approved for PrEP in 2012 after being shown to be highly effective when taken with excellent adherence. The adherence challenges of taking a pill a day have always been its Achilles heel. Headache, abdominal pain, and decreased weight were the most common side effects attributable to Truvada in PrEP trials, and a few more people stopped drug for elevated creatinine or protein in the urine in the Truvada arm than the placebo arm. Bone density decreased more on Truvada than placebo, but the incidence of fractures was low and similar in both arms.
Tenofovir levels are increased with the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) and close monitoring of TDF-related toxicities is recommended.
For individuals, there should be no out-of-pocket cost for the drug or PrEP services (office visits, lab monitoring including STI screening) due to an “A” rating from the U.S. Preventative Services Task Force. I have to say that we badly botched the rollout of PrEP in the U.S., with many people who could benefit still lacking access to PrEP, and disparities by race, ethnicity, and gender writ large. We should learn from these mistakes as we have yet another opportunity to introduce PrEP to America with the approval of injectable cabotegravir (see Apretude) and the chance to make all PrEP available at no cost to people who wish to take it.
Activist Michael Broder:
Truvada (approved for PrEP in 2012) has largely been supplanted by Descovy, which replaces the TDF in Truvada with tenofovir alafenamide (TAF). TAF may be safer than TDF for bones and kidneys. This is especially important for people under 25, who are still actively developing bone, and for people who have mild to moderate kidney disease. On the other hand, TDF may be better than TAF when it comes to cholesterol and weight gain. If your provider recommends Truvada for PrEP rather than Descovy, they may well have a good reason, but make sure they tell you what it is.