What Is Viread?
Viread was the first HIV medication to be sold by Gilead. It was approved by the Food and Drug Administration (FDA) in 2001 and is still being sold as of 2019.
When Viread was introduced, it was hailed as a “miracle” by Gilead salesmen. This is because Viread allowed people to access a drug called tenofovir in a pill form.
Tenofovir is a compound that prevents the spread of HIV. It was first discovered in the 1980s, but it could only be given intravenously.
In response, Gilead developed an alternate form of the compound called tenofovir disoproxil fumarate (TDF). This modified form of tenofovir could be taken by mouth.
That being said, Viread was not the miracle drug it was made out to be. Gilead allegedly claimed the drug was not toxic during early promotions. However, TDF has been linked to kidney failure and bone damage.
Viread also comes with a high price tag — costing users over $13,000 a year depending on insurance coverage — even though it can be dangerous to their health. This doesn’t account for the doctors’ bills and treatment costs for the side effects that may occur.
Even more distressing, Gilead had access to a safer alternative to TDF even before Viread was approved by the FDA. This drug is called tenofovir alafenamide fumarate (TAF).
TAF is much less toxic to the human body. Yet, Gilead did not use it in its HIV treatments until 2015 so the company could make more money from its TDF drugs.
Some of those who use Viread and other Gilead drugs — or who have used them in the past — and developed serious side effects are now filing lawsuits to receive compensation for their injuries.
Who Can Take Viread?
Viread has been typically prescribed to those with HIV infections. It is usually administered in a once-a-day pill. The official product description for Viread notes that those with chronic hepatitis B can also take Viread as a treatment.
Unlike other HIV drugs such as Truvada, Viread cannot be taken as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection. It can only be used as a treatment for those already infected with HIV.
Anyone who uses Viread, or may use the medication in the future, should consult with their doctor about the benefits, risks, and cost beforehand.
Though Viread has been sold for nearly 20 years, it can be hard to afford even today.
According to a 2018 study showcased by the National Institutes of Health (NIH), Gilead charges between $1,140 to 1,368 for a month’s supply of Viread.
Coupled with the drug’s side effects, this price makes Viread both costly to a person’s finances and health.
Is Viread Generic Medication Safer?
As of late 2017, several generic versions of Viread may be available to the public. These generic forms of Viread provide the same effects but are sold at lower prices, making them more affordable.
However, these generic forms of Viread still contain TDF, meaning they are just as dangerous to human health.
Viread Side Effects
Today, Viread produces serious, long-term side effects related to the kidneys and bones. These side effects stem from the TDF found in the drug.
According to legal complaints, Gilead had data showing TDF put people in danger of kidney and bone toxicities — yet, the company sold the drug anyway.
Notable Viread side effects include:
- Acute Kidney Injury (AKI): Kidneys remove the toxins from your blood. However, in the case of an AKI, the kidneys suddenly stop working properly. This causes waste and toxins to build up, damaging other parts of the body like the brain or heart.
- Chronic Kidney Disease (CKD): Unlike an AKI, kidneys affected by CKD gradually weaken over time. Because of this, you may not realize you have CKD at first. However, CKD can have deadly complications if it progresses.
- Kidney Failure: Eventually, CKD can cause your kidneys to fail completely. Once your kidneys fail, you will need dialysis or a kidney transplant to stay alive. Kidney failure is also known as end-stage renal disease (ESRD).
- Renal insufficiency/impairment: This condition is similar to chronic kidney disease. The kidneys have begun to weaken, but they have not completely failed. There were 42 cases of renal insufficiency related to Viread within the first 24 months that the drug was sold.
- Bone breaks/fractures: Reports of fractures and breaks are common among those who took Viread for long periods of time, as the drug causes bones to become weaker.
- Bone density loss: Your body continues to grow new bone tissue to replace old bones throughout your lifetime. Long-term use of Viread can prevent your body from growing new bone tissue fast enough, causing your existing bones to become weak. This increases your risk of broken bones and can even lead to osteoporosis.
- Osteoporosis: This disease causes bones to become weak and thin, increasing the risk of fractures. Women have a higher risk of osteoporosis, but anyone can develop it.
- Tooth loss: Using Viread can cause deterioration of the jawbone. This, in turn, can even cause your teeth to fall out.
Initially, the side effects of Viread were not widely known. For example, Viread’s initial product warnings claimed kidney damage was only a risk for those with pre-existing conditions.
In fact, Gilead came under scrutiny by the FDA after the drug was approved for downplaying the associated health risks. As a result, the company had to update its warning labels multiple times to account for additional kidney and bone problems.
Viread FDA Approval
While Viread was approved by the FDA in 2001, Gilead received repeated warnings from the FDA about Viread and its labeling.
Here is a timeline of Viread’s approval and later controversies:
- October 26, 2001: Viread is approved by the FDA.
- March 14, 2002: Gilead receives a warning letter from the FDA. In the letter, the agency states that Gilead illegally downplayed Viread’s risks, such as those related to kidney damage. The letter claims the company violated the Federal Food, Drug and Cosmetic Act by doing so.
- July 29, 2003: Gilead receives a second warning from the FDA. This time, the FDA states that sales representatives from Gilead minimized the factual dangers of Viread. As a result, the agency forced Gilead to retrain its staff so Viread could be promoted properly.
- August 11, 2008: The FDA approves Viread for use among patients with chronic hepatitis B.
- January 19, 2012: The FDA approves several alternate versions of Viread: lower-dose pills for children aged 6-12 and a powder form for children aged 2-5.
Viread Legal Action
While Viread is still available today, that doesn’t mean it is safe for consumers.
A 2018 lawsuit filed in California claims that Viread did not have general warnings for kidney issues until 2007. Until that time, warnings for kidney disease only applied to those already at risk of kidney disease or those taking other medications that could harm the kidneys.
Further, the lawsuit claims that Gilead did not properly warn users about bone problems until late 2003 and claims that only people already at risk for bone problems should be monitored for these health issues.
This lawsuit and others seek financial compensation to pay for health issues victims now face, including kidney failure, kidney disease, and osteoporosis.
If you use Viread or used the medication in the past and developed kidney or bone problems, you may also be able to receive compensation.