Gilead Sciences manufactures Truvada, and its active ingredients are emtricitabine and tenofovir disoproxil fumarate. Other HIV drugs that share Truvada’s active ingredient tenofovir disoproxil fumarate include Viread, Atripla, Complera and Stribild.
The U.S. Food and Drug Administration first approved the drug in 2004 to treat HIV, and then approved it for PrEP in 2012.
PrEP, or pre-exposure prophylaxis, is an HIV prevention strategy that allows people who have tested negative for infection to reduce their risk of acquiring HIV. One pill a day can reduce the risk of getting HIV from sex or intravenous drug use by as much as 99 percent, according to the Centers for Disease Control and Prevention.
Out of about 1.1 million people at risk for HIV in the United States, approximately 200,000 use Truvada for PrEP. Truvada was the only drug approved for PrEP in the United States until 2019, when the FDA also approved Gilead’s newer drug Descovy for PrEP.
In September 2020, Teva Pharmaceuticals will manufacture the first generic version of Truvada, according to Gilead’s March 2019 quarterly report.
What Does Truvada Do?
Truvada works by preventing the HIV virus from multiplying. The drug blocks a specific enzyme in the body called HIV reverse transcriptase that allows HIV cells to make more infected cell copies. It does not cure HIV or prevent other sexually transmitted diseases.
The HIV medication is most effective when taken every day and reduces HIV infection risk by up to 99 percent. A key Truvada study called the iPrEx trial found that people who only took two doses a week went down from 99 percent risk reduction to 76 percent. People who took it four times a week had a risk reduction of 96 percent.
Before a health care provider will prescribe the drug, they will typically test for HIV and hepatitis B infections. They will also usually test the patient’s kidney and liver function.
Side Effects and Safety Information
Most patients tolerate Truvada well and don’t report side effects. But in clinical trials, the most common Truvada side effects in patients who take it for PrEP are headache, abdominal pain and weight loss. For most people, these mild to moderate side effects only lasted for a few weeks after taking the HIV medication.
HIV-infected people using Truvada to treat HIV suffered more side effects than those who took it for PrEP.
- Abdominal pain
- Abnormal dreams
- Weight loss
On rare occasions, serious side effects can occur. These include kidney problems, lactic acidosis, decreases in bone mineral density and immune reconstitution syndrome — a condition that causes serious infections in people taking antiretroviral drugs.
Truvada has a black box warning for severe acute exacerbation of hepatitis B virus, or HBV, in patients who stop taking Truvada. Health providers should monitor patients with HBV who stop taking the drug.
Some people who suffered kidney damage and bone problems filed Truvada lawsuits against Gilead. The lawsuits claim the drug company failed to adequately warn them. They also say the drug maker purposely delayed the release of Descovy, a drug that is less harmful to the kidneys and bones.
How Do I Pay for PrEP?
Without insurance, Truvada costs between $1,600 and $2,000 for a one-month supply. Critics say the high cost of the drug prevents people from getting treatment. But there are a few programs that could help people get the drug for as little as $0.
Under the Affordable Care Act, also known as Obamacare, private insurers are required to cover preventative care if the U.S. Preventative Services Task Force gives a medication an “A” or “B” rating. In 2019, the task force gave PrEP an “A” rating. This means people with private insurance will soon get Truvada at no cost.
People should check with their insurance provider for an out-of-pocket cost estimate for their HIV medication.
Gilead Advancing Access Program
Gilead provides the Gilead Advancing Access program for people with private insurance or no insurance. The program helps people afford their HIV medication.
For people with commercial insurance, the program provides a coupon card that covers up to $7,200 in co-pays per year for Truvada for PrEP. For some people, this means they will pay as little as $0 for PrEP.
People without insurance may be able to get Truvada at no cost if they qualify for the Medication Assistance Program. If they do not qualify, Gilead Advancing Access can help find alternative coverage options.
People with government insurance including Medicare, Tricare or VA are not eligible for the assistance program, but Gilead may still be able to help them find financial support for their medication.
Gilead Donates PrEP Medication to CDC
On May 9, 2019, Gilead announced it would donate up to 2.4 million bottles of Truvada each year to the Centers for Disease Control and Prevention.
The donation is intended for uninsured Americans at risk of HIV. Gilead plans to continue donating until 2030. It also plans to eventually transition its donation to Descovy for PrEP.
In addition to applying for Gilead’s Medication Assistance Program, uninsured people can check with local LGBTQ+ centers or non-profits to get access to free or low-cost PrEP medication.
Adults take one pill for PrEP once a day with or without food, according to the drug’s medication insert. It takes at least seven days after starting PrEP for the drug to reach maximum effectiveness. People should make sure they practice safe sex and use condoms because Truvada alone may not prevent HIV infection.
Take the pill each day and don’t skip doses. Skipping doses lowers Truvada’s effectiveness and exposes people to infection.
Truvada comes in pills that contain a combination of emtricitabine and tenofovir disoproxil fumarate in doses from 100 mg/150 mg to 200mg/300mg.
Adults using Truvada for PrEP or to treat HIV in combination with other antiretrovirals typically take the highest strength pill, 200mg/300mg.
Pediatric patients take dosages adjusted for their weight. People with kidney problems may not be able to take Truvada or may take a lower dose.
Some drugs and substances can interact with Truvada. These interactions can cause additional side effects or prevent drugs from working effectively.
- Increased dianosine concentrations may cause symptoms of didanosine toxicity such as pancreatitis or neuropathy.
- Drugs That Affect Renal Function.
- Drugs that reduce kidney function in combination with Truvada can increase levels of the drug in the blood. Examples include: cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, gentamicin, and NSAIDs.
- Hepatitis C Antiviral Agents.
- Hepatitis C drugs such as Epclusa and Harvoni increase concentrations of Truvada and may cause more adverse reactions.
- HIV-1 Protease Inhibitors.
- Drugs such as atazanavir and ritonavir, darunavir and ritonavir, or lopinavir/ritonavir may be less effective, but they may increase levels of Truvada. This can cause toxicity.
This isn’t a complete list of all drug interactions. People should tell their health care providers about all medications, vitamins and herbal supplements they take.
Descovy vs Truvada
Descovy is the only other drug approved for PrEP in the United States. It works similarly to Truvada and contains the same active ingredient emtricitabine. But the second ingredient in Descovy is tenofovir alafenamide instead of tenofovir disoproxil fumarate.
In studies, Descovy worked as well as Truvada at preventing HIV infection in men who have sex with men and transgender women. Gilead did not test the drug for PrEP in cisgender women, so the FDA did not approve it for these patients. The FDA approved Truvada for PrEP in all people at risk of HIV infection.
In clinical trials, researchers found Descovy was less harmful to bones and kidneys than Truvada. Both drugs are similar in cost, but Truvada will be available in generic form beginning September 2020.
16 Cited Research Articles
- Anderson, P.L. et al. (2012, September 12). Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men (iPrEx). Retrieved from https://stm.sciencemag.org/content/4/151/151ra125
- Centers for Disease Control and Prevention. (n.d.). HIV/AIDS. Retrieved from https://www.cdc.gov/msmhealth/HIV.htm
- Centers for Disease Control and Prevention. (n.d.). PrEP. Retrieved from https://www.cdc.gov/hiv/basics/prep.html
- DailyMed. (2018, May 18). Truvada- emtricitabine and tenofovir disoproxil fumarate tablet, film coated. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e82b13-a037-49ed-b4b3-030b37c0ecdd&audience=consumer
- DailyMed. (2019, October 11). Descovy- emtricitabine and tenofovir alafenamide tablet. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06f66e98-e6ee-4538-9506-6c1282cc14c1&audience=consumer
- Gilead Sciences, Inc. (2018, December 31). Form 10-K, Annual Report. Retrieved from http://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_GILD_2018.pdf
- Gilead Sciences, Inc. (2019, March 6). Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy vs. Once-Daily Truvada for Prevention of HIV Infection. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2019/3/gilead-announces-data-demonstrating-noninferiority-of-oncedaily-descovy-vs-oncedaily-truvada-for-prevention-of-hiv-infection
- Gilead Sciences, Inc. (2019, March 31). Form 10-Q, Quarterly Report. Retrieved from http://investors.gilead.com/static-files/0ff8d741-b9eb-4162-bcb4-f16094d37254
- Gilead Sciences, Inc. (2019, May 9). Gilead Sciences to Provide Free Truvada for PrEP to Support U.S. Initiative to End the HIV Epidemic. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2019/3/gilead-announces-data-demonstrating-noninferiority-of-oncedaily-descovy-vs-oncedaily-truvada-for-prevention-of-hiv-infection
- Gilead Sciences. (2019, October 3). U.S. Food and Drug Administration Approves Descovy for HIV Pre-Exposure Prophylaxis (PrEP). Retrieved from https://www.businesswire.com/news/home/20191003005779/en/U.S.-Food-Drug-Administration-Approves-Descovy®-HIV
- Gilead Sciences. (n.d.). Gilead Advancing Access Program. Retrieved from https://www.truvada.com/how-to-get-truvada-for-prep/truvada-cost
- Gilead Sciences. (n.d.). Truvada. Retrieved from https://www.truvada.com
- Healio Infectious Disease News. (2019, May 9). Gilead says generic Truvada will be available in 2020. Retrieved from https://www.healio.com/infectious-disease/hiv-aids/news/online/%7B62f21440-4f18-44cd-b0c9-fb011c28f531%7D/gilead-says-generic-truvada-will-be-available-in-2020
- Lovelace, B., Jr. (2019, June 11). Free daily HIV prevention pills will soon be available to private insurance holders. Retrieved from https://www.cnbc.com/2019/06/11/private-insurers-must-cover-prep-at-no-cost-to-high-risk-patients.html
- Rosenberg, J. (2019, May 10). Reactions Are Mixed as Gilead Announces PrEP Donations, Early Launch of Generic. Retrieved from https://www.ajmc.com/newsroom/reactions-are-mixed-as-gilead-announces-prep-donations-early-launch-of-generic
- San Francisco AIDS Foundation. (n.d.). PrEP: The Basics. Retrieved from https://prepfacts.org/prep/the-basics/