In recent months there has been a growing increase in the number of injuries claimed by users of the drug Truvada. Truvada is an HIV drug that is prescribed to both people with HIV and those who are at high risk for contracting HIV through occupational, sexual or lifestyle activities.
In 2004, Truvada was introduced to treat individuals with HIV in a combination with NRTI’s. Again, this was a breakthrough in medications aimed at helping treat individuals with HIV. In recent months, Truvada, was approved by the FDA to treat individuals that are HIV negative as a protection against contracting HIV. This is often referred to as pre-exposure prophylaxis (PrEP).
Some of the injuries being claimed by Truvada users are kidney failure, kidney damage, bone loss, fractures, lactic acidosis, and liver problems (including liver failure). Less serious side effects are: rash, difficulty sleeping, dizziness, weight loss, fatigue, diarrhea and abdominal pain.
The lawsuits being filed accuse Gilead, the manufacturer of Truvada, of creating a defective product and failing to warn the public of Truvada’s risks in a sufficient manner.
Drug manufacturers have a legal duty to warn the public about the risks and dangers that are associated with taking their drugs. This is a legal duty because it allows patients and their physicians to make informed decisions conceding which drugs they should take. Drug companies, however, are often reluctant to disclosure this information because it hurts their sales. This is putting profits over people.
HIV is a devastating disease. More than 35 million people around the world and more than 700,000 in the United States alone have died from HIV. As recent as 2017, the Center for Disease Control and Prevention (CDC) reported that over a million people in the U.S. were living with HIV, 40,000 people were recently diagnosed with HIV and over 5,000 people had died from the disease. If left untreated, the HIV virus will weaken a patient’s immune system to a debilitating condition known as Acquired Immunodeficiency Syndrome (AIDS). The HIV virus destroys the body’s immune system by destroying the T-helper cells. This is accomplished by the virus replicating itself inside the T-cells. Once this occurs, the body’s immune system will cease to effectively fight off infections leaving in the infected individual susceptible to deadly infections.
The first drug to treat HIV was azidothymidine (AZT) was cleared by the FDA in 1987 but it wasn’t until 1996 that any real effective therapy became available. In the past several years, there have been huge advances in the treatment for HIV and AIDS. Nucleoside reverse transcriptase inhibitors (NRTI’s) changed the death sentence often associated with an HIV diagnosis. The virus could finally be manageable and individuals with HIV could continue to lead a fulfilling life. In the years since, Gilead has maintained what has been alleged as a “monopoly” on HIV drugs. Tenofovir disoproxil fumarate (TDF) is one of the drugs Gilead markets as part of the HIV antiviral medications called nucleoside reverse transcriptase inhibitors (NRTI’s). TDF is prescribed and sold by Gilead under the brand name Viread, and is also a component of Truvada. TDF is also a component of Atripla, Complera, Stribild, Cimduo, Genvoya, and Symbian-Lo. Truvada is effective in managing a patient’s viral load but may also cause very severe side-effects.
The Truth Behind Gilead
Gilead has known of these serious side effects for a long time. The problem with Truvada is the drug’s bioavailability requiring it to be ingested at high doses in order for it be remain effective in combating the HIV virus. The high doses required severely tax a patient’s body by requiring it to process and metabolize large amounts of the drug in addition to fighting the HIV virus and stop or slow its replication. Gilead knew of the serious strain that Truvada placed on patient’s bodies early in the development of the drug. They also knew that a patient’s bones and kidneys were likely to bear the brunt of this harm leading to kidney damage, kidney failure, bone necrosis (bone death), bone mineral density loss and bone fractures. Reports of lactic acidosis and liver damage have also been reported. Gilead failure to warn the public and doctors of the dangers of Truvada.
To add insult to injury, Gilead allegedly had developed a safer and more effective alternative to Truvada but intentionally withheld the drug from the public. This drug is known as tenofovir alafenamide (TAF). Gilead knew that if the released the safer TAF , more effective drug, that its sales fo Truvada would be undercut. Simply put, they would lose money. Due to sales of Truvada, Gilead has a market capitalization of $40 Billion and has seen its profits grow from $5 billion in 2009 to over $10 billion in 2015. Gilead did not release the safer more effective drug TAF until the patent protection ran out on Truvada and it became less profitable.
Warning Signs & Symptoms of Kidney Failure Include:
- Increased bruising or bruising easily
- Increased bleeding
- Unusual thirst
- Loss of appetite
- Difficulty concentrating
- Muscle cramps
- Increased urination at night
- Numbness in fingers and toes
- Itchy skin
- Itchy eyes
- Changes in skin color
- High blood pressure
- Urinating less frequently
- Difficulty digesting food
- Difficulty breathing
- Swelling and puffiness
- Bone pain
- Bone fractures
- Muscle pain
- Pain in the extremities
Warning Signs and Symptoms of Bone Loss & Osteoporosis:
- Back pain
- Loss of height
- Poor posture
Warning signs and symptoms of lactic acidosis include:
- Unusual fatigue (tired more than usual or easily becoming tired)
- Muscle pain
- Short of breath
- Nausea and vomiting
- Stomach pain (abdominal pain)
- Blue skin on hands or feet
- Cold hands or feet
- Rapid heart beat
Truvada is claimed to cause an increase risk for the above conditions that is compounded in individuals that are overweight (obese), pregnant, or have poor liver function. In addition, individuals with a low CD4 cell count are at an Inca fried risk of developing lactic acidosis.