Truvada is a medication used for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of HIV infection. It can also be used to treat HIV in combination with other medicines.

While Truvada has eliminated much of the anxiety and fear surrounding HIV and AIDS, especially within the LGBTQ community, the drug has been linked to the weakening of bones and other potentially life-threatening side effects.


The Truth

Studies + Science

Regulation Recap

The Next Steps
Truvada has been a milestone for communities affected by HIV/HIDS, however, it may cause side effects.Truvada has been linked to nearly 6,000 bone breaks.Lawsuits against Truvada have been filed for failure to warn consumers of the side effects.Though Truvada is a life-saving medication, it may affect patients who could be eligible for compensation.

 

The Truth

Two men who are aware of but not affected by Truvada side effects

Manufactured by Gilead Sciences Inc., Truvada is a prescription medication used in to reduce the risk of HIV infection in adults and adolescents who are HIV-negative and at risk of getting HIV.  Truvada is also used in combination with other HIV medicines to treat HIV in adults and children to help them live longer, healthier lives and reduce the risk of transmission

To take Truvada for PrEP, of which the dosage is one pill a day, patients must be HIV-negative and are advised to combine the medication with safe sex practices and regular testing to more effectively decrease their chances of contracting HIV. Patients should take the pill at the same time each day, not just on days they might be at risk of exposure.

The list price for Truvada is nearly $2,000 for a 30-day supply, and most health insurers and state Medicaid agencies cover the drug.

Studies + Science

How Truvada Works

Truvada’s Uses
For PrEP to reduce the risk of HIV infection in adults and adolescents who are HIV-negative and at risk of getting HIV.In combination with other HIV medicines to treat HIV in adults and children to help them live longer, healthier lives and reduce the risk of transmission.

Truvada combines two HIV medicines in one pill: emtricitabine and tenofovir disoproxil fumarate, which belong to the group of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). They block an HIV enzyme called reverse transcriptase and prevent the disease from multiplying and can reduce the amount of HIV in the body. Research shows that proper use of Truvada can reduce the risk of infection by 92 percent and can be up to 99 percent effective when taken daily.

In 2010, an iPrex study revealed that, overall, Truvada reduced the rate of new infections by 42 percent. In participants with monthly blood levels of the drug equal to 7 days of dosing per week, the efficacy was 99 percent, and in participants who reported taking Truvada more than 90 percent of the time, efficacy was 73 percent

Truvada Bone Loss

Truvada has been linked to nearly 6,000 bone breaks, and one study found that bone mineral density “declines by 2-6 percent in the first two years of Truvada treatment.”

Common Side Effects of Truvada

The U.S. Department of Health and Human Services lists common side effects of Truvada as:

  • Headache
  • Stomach ache
  • Weight loss

Serious Side Effects of Truvada

Truvada can also cause potentially life-threatening side effects, such as severe bone loss and liver problems, a buildup of lactic acid in the blood (lactic acidosis) and kidney failure. Truvada users should contact their health care provider immediately if they experience any of the following symptoms:

    • Weakness or tiredness
    • Unusual muscle pain
    • Shortness of breath or fast breathing
    • Stomach pain with nausea and vomiting
    • Hands or feet that feel cold or turn blue
    • Dizziness or lightheadedness
    • Fast or abnormal heartbeat
    • Jaundice
    • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Abdominal pain

 

Regulation Recap

2012 | FDA Approves Truvada

The drug was first approved by the FDA as an HIV prevention method for adults in 2012. Truvada marks a new chapter for the LGBTQ community when it comes to safe sex and eradicating the fear surrounding HIV and AIDS. Access to and correct usage of the drug means a safer and healthier sex life for all.

A non-binary person thinking about Truvada bone loss and how it affects the community
Photo by Sharon McCutcheon on Unsplash

2018 | FDA Expands Truvada Approval 

The FDA expanded its approval in 2018 to include at-risk adolescents weighing at least 77 pounds.

2018 | Lawsuits Fied for Truvada Bone Density Loss

In May 2018, lawsuits were filed in California against Gilead, claiming the company refrained from releasing a safer HIV drug it had also been testing in the early 2000s in order to keep the multi-billion dollar patent for Truvada. The company was also accused of misinforming patients and physicians about possible side effects. Gilead continued to make money off of the drug as Truvada users suffered the consequences because they were simply unaware.

Injury claims against Truvada include:

  • Strict products liability—design defect and failure to warn
  • Negligent products liability—design defect and failure to warn
  • Breach of implied warranty
  • Breach of express warranty

As previously reported by MedTruth, Gilead was apparently aware from their own studies that Truvada was “highly toxic” and resulted in “possible fatal damage to the kidneys and bones.” In 2002 and 2003, the FDA issued warning letters to Gilead over its marketing practices for the drug stating representatives violated the law by giving doctors and patients false and misleading information regarding side effects.

2019 | Discrimination Lawsuits Filed Against Insurers 

In January 2019, The New York Times reported that Massachusetts attorney general’s office filed allegations of discrimination against insurer Mutual of Omaha for denying policies to applicants, mostly gay men, who took Truvada. Some men said they even stopped taking Truvada, potentially endangering themselves, just to obtain insurance. At the same time, the company settled an LGBTQ Legal Advocates and Defenders (GLAD) lawsuit on behalf of an anonymous 61-year-old man who was allegedly one of those discriminated against for taking Truvada. The lawsuit was the first of its kind and alleged that Mutual of Omaha violated Massachusetts laws that prohibit discrimination on the basis of sexual orientation and disability.

The company admitted no wrongdoing in the settlements but will pay $25,000 to the state and has agreed to provide insurance to people who use medication to prevent HIV infection. Per previous Medtruth reporting, the state of New York declared such insurer behavior unlawful.

2019 | DISCOVER Trial Results Show Similar Drug Descovy May Be Safer 

Gilead announced in March 2019 that results were in from the DISCOVER trial of Descovy, a drug similar to Truvada for PrEP. Descovy achieved a clinical profile similar to the high efficacy of Truvada but had a more favorable bone and renal safety profile, according to Gilead, who will file regulatory applications for Descovy for PrEP. In 2021, Truvada will come off patent, meaning other drugs may be produced.

Next Steps

If Truvada is part of your daily routine, take the side effects seriously, as lactic acidosis and kidney failure can be life-threatening. As we near 2021 when the drug will come off patent, generic and potentially safer HIV drugs will begin to surface.

 

Individual readers should not act or refrain from acting based on MedTruth's content 
without seeking advice from a licensed medical professional.