Tenofovir Disoproxil Fumarate (TDF) Medications

What is Tenofovir Disoproxil Fumarate?

Tenofovir Disoproxil Fumarate (TDF) is a prescription medication frequently used in the treatment and prevention of HIV. TDF is a nucleoside reverse transcriptase inhibitor (NRTI) used to block reverse transcriptase (an HIV enzyme). The reverse transcriptase enzymes allow HIV to multiply within the body, therefore by blocking the enzyme the multiplication process can be halted, and reduced and ultimately the amount within the body will decrease over time.

While there is currently no medication on the market that can completely cure HIV/AIDS, the combined use of TDF and other HIV medications has proven to help those living with HIV to live longer, healthier lives than those who opt to decline treatment. An additional benefit, is these medications help to reduce the risk of HIV transmission to other partners. TDF is now also being used to treat those with chronic hepatitis B viral infections (HBV).

Use of TDF-based antiretroviral drugs exploded after being introduced to the market, and patients quickly adopted these drugs into their daily routines in hopes of happier, healthier lives. However, even with lower transmission rates and viral treatment, some side effects of these medications have proven to be quite severe. Side effects include but are not limited to kidney, bone and liver problems that arise from the buildup and prolonged use of TDF-based drugs. 

TDF based antiretroviral drugs exploded after being introduced to market, and patients quickly adopted these drugs in hopes of happier, healthier lives. 

What are some of the possible side effects of TDF use?

TDF has a variety of common side effects like: dizziness, muscle pain, weakness or feeling tired, nausea, vomiting, loss of appetite, stomach pain, etc. If you are currently experiencing any of these symptoms contact your doctor immediately.

TDF has also been linked to several severe side effects including kidney, bone and liver problems. If you experience any side effects it is important to discuss them with your doctor to ensure they do not progress into something serious.

Kidney Injuries:

Acute Kidney Injury (Acute Renal Failure) – Acute kidney injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in your blood and makes it hard for your kidneys to keep the right balance of fluid in your body. AKI can also affect other organs such as the brain, heart, and lungs.1 (National Kidney Foundation)

Chronic Kidney Disease – Chronic kidney disease, also called chronic kidney failure, describes the gradual loss of kidney function. Your kidneys filter wastes and excess fluids from your blood, which are then excreted in your urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes can build up in your body.2 (Mayo Clinic)

Fanconi Syndrome – Fanconi syndrome is a disorder of the kidney tubes in which certain substances normally absorbed into the bloodstream by the kidneys are released into the urine instead.3 (Medlineplus.gov)

Renal Tubular Acidosis – Renal tubular disorders occurs when the kidneys fail to excrete acids into the urine, which causes a person’s blood to remain too acidic. Without proper treatment, chronic acidity of the blood leads to growth retardation, kidney stones, bone disease, chronic kidney disease, and possibly total kidney failure.4 (National Institute of Diabetes and Digestive and Kidney Diseases)

Bone Injuries:

Osteopenia (bone thinning) – Osteopenia is when your bones are weaker than normal but not so far gone that they break easily, which is the hallmark of osteoporosis.(Web M.D.)

Osteoporosis (bone density loss) – Osteoporosis causes bones to become weak and brittle — so brittle that a fall or even mild stresses such as bending over or coughing can cause a fracture. Osteoporosis-related fractures most commonly occur in the hip, wrist or spine.6 (Mayo Clinic)

Liver Injuries:

Lactic Acidosis – Lactic acidosis occurs when the body produces too much lactic acid and cannot metabolize it quickly enough. The condition can be a medical emergency. The onset of lactic acidosis might be rapid and occur within minutes or hours, or gradual, happening over a period of days. The best way to treat lactic acidosis is to find out what has caused it. Untreated lactic acidosis can result in severe and life-threatening complications. In some instances, these can escalate rapidly.(Medical News Today)

Who manufactures TDF drugs?

Gilead Sciences, Inc. is a biotech company who produces many of the leading TDF medications: Viread, Truvada, Atripla, Complera and Stribild. Based in Foster City, CA the company has prominently lead the charge on TDF medications since they came to market in 2003 and were approved by the FDA in 2012.

Current TDF lawsuits

In 2018, Gilead was named the defendant in multiple lawsuits. The plaintiffs in the cases alleged that their HIV drugs (Viread, Truvada, Atripla, Complera and Stribild) caused kidney and bone damage. They filed a motion to dismiss all allegations, but the motion was declined. U.S. District Judge, Jon S. Tigar held that “Gilead could have independently complied with both state and federal law prior to submitting the TDF drugs for FDA approval. Because Gilead has not presented ‘clear evidence’ that the [U.S. Food and Drug Administration] would not have approved the allegedly safer versions of the drugs that plaintiffs contend would have complied with state law, plaintiffs’ pre-approval design-defect claims are not preempted.”8 Due to Gilead’s omissions plaintiffs’ claims of fraud and consumer protection were allowed to proceed.

Additionally, Gilead is facing severe scrutiny over their current HIV drug patents. Many HIV/AIDS activists accuse the corporation of “withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada.”(Biospace) Gilead, along with Bristol-Myers Squibb and Johnson & Johnson have become the defendants of a San Francisco-based suit claiming, “the companies used anticompetitive tactics to keep prices artificially high for their respective HIV treatments. Drugs singled out in the complaint include Truvada, Descovy, Atripla, Genvoya, and Odefsey. Also, the lawsuit named Viread, Emtriva, Complera, Stribild, Vemlidy, Reyataz, Evotaz, Prezista, Prezcobix, Edurant, Symtuza, and Tybost.”(Biospace)

If you or a loved one have suffered from the side effects of TDF treatment, contact Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC to schedule a consultation. Call 973-274-5200 or email pdacosta@sarnolawfirm.com to schedule your consultation.