What Is Complera?
Created by Gilead Sciences, Complera is a medicine generally used to treat people newly infected with human immunodeficiency virus (HIV). Gilead Sciences created the once-a-day tablet by combining three antiretroviral medicines — emtricitabine, rilpivirine, and tenofovir disoproxil fumarate (TDF).
Complera gained FDA approval on August 10, 2011. However, the expensive drug has many health risks, including kidney and bone damage that has been linked to one of its main ingredients, TDF.
Complera users are now filing lawsuits against Gilead Sciences for using TDF in the drug rather than a safer alternative and for failing to properly warn patients about TDF’s serious side effects.
Who Can Take Complera?
Complera is prescribed to people who have never taken HIV medication before and who have no more than 100,000 copies/mL of HIV in their blood. It may also be prescribed as an HIV drug replacement for certain people with a viral amount of fewer than 50 copies/mL.
Anyone considering new medication or stopping an existing drug routine should consult with their doctor for specific medical advice.
Complera is extremely expensive. In late 2018, the U.S. Department of Health and Human Services listed the cost of Complera can range from $2,680-$3,200 a month before insurance or government aid.
Each patient’s cost will also vary based on pharmacy used and number of pills purchased. Currently, Complera has no generic equivalent, keeping prices high.
Complera vs Truvada
While Complera and Truvada are both HIV treatment drugs created by Gilead, they are not interchangeable.
Learn more about the main differences between Complera and Truvada:
- First approved by the FDA on August 10, 2011
- Approved for use as an HIV treatment
- Active ingredients are emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
- Taken once a day for HIV treatment without other HIV drugs
- The approximate price is ~$3,000/month
- First approved by the FDA on August 2, 2004
- Approved for use as an HIV treatment and HIV Prevention (PrEP)
- Active ingredients are emtricitabine and tenofovir disoproxil fumarate
- Taken once a day for HIV treatment with other HIV drugs or for HIV prevention
- The approximate price is ~$2,000/month
Complera Side Effects
The three drugs in Complera may cause several side effects, and while many are mild, some may lead to hospitalization or even death.
The most common side effects of Complera are:
The TDF in Complera may also lead to kidney and bone problems. Many victims suffering from TDF-related injuries argue that Gilead downplayed the seriousness of potential side effects to avoid hurting sales.
- Acute Kidney Injury (AKI): When the kidneys suddenly stop functioning, waste builds up in the blood. AKI may lead to permanent kidney damage or even death.
- Chronic Kidney Disease (CKD): CKD is the gradual loss of kidney function. This condition often has no symptoms until it has advanced considerably.
- End-Stage Renal Disease (ESRD): Also called renal failure, ESRD is the last stage of CKD. The kidneys can no longer filter blood, which may lead to death without dialysis or a kidney transplant.
- Renal insufficiency/impairment: This condition describes below average kidney function.
- Fanconi syndrome: This disorder causes the kidneys to release substances into the urine instead of absorbing them into the bloodstream, causing nutritional deficiencies and loss of electrolytes.
- Osteoporosis: People with this condition have extremely fragile bones, leading to an increased risk of fractures.
- Bone density loss: When bone tissue is absorbed more quickly than it is replaced, this bone density loss may lead to osteoporosis.
- Bone breaks/fractures: Bone density loss increases the risk of bone fractures — painful breaks in the bone.
- Tooth loss: When bone tissue is lost in the jawbone, teeth may loosen and fall out.
People taking Complera should be especially aware of a few other potential side effects.
- Lactic acidosis: People who take Complera may build up too much lactic acid in the blood. While rare, lactic acidosis is a medical emergency that may lead to death.
- Skin rash: Skin rash is a common side effect of Complera, but it may be severe enough to require immediate medical help, especially if paired with a fever, swelling, abdominal pain, or other symptoms.
- Severe liver problems: Complera may cause liver problems that are occasionally severe enough to be fatal. Those with a history of liver problems are at increased risk of developing worse problems after taking Complera.
Complera FDA Approval
Complera was approved by the FDA to treat HIV-1 on August 10th, 2011. It was the second once-daily HIV pill to be approved, after Atripla in 2006.
Along with its approval, the FDA reported several warnings about Complera’s side effects. This included concerns about TDF’s effects on bone mineral density and on the kidneys.
The report encouraged health professionals to screen patients for any preexisting bone or kidney problems before prescribing Complera, to monitor patients’ health, and to prescribe supplements for bone health.
Complera Legal Action
Complera’s once-a-day formulation has helped many HIV-positive people manage their disease more easily. However, the HIV drug poses some serious side effects, including kidney and bone damage.
Recently, victims who have suffered from such side effects are fighting back against Gilead and other HIV drug companies, claiming that Gilead withheld a safer version of TDF in order to maximize profits on the older drug. Furthermore, it allegedly downplayed the seriousness of TDF’s side effects.
If you have suffered from serious bone or kidney problems as a result of taking Complera or another TDF drug, there is hope. Filing a Complera lawsuit can help you pay for the expensive medical treatment these drugs can cause — and help hold HIV drug companies responsible to the people they are supposed to help.