Truvada is one of the more popular brand names for TDF drugs. It is also sold under other brand names. TDF stands for tenofovir disoproxil fumarate. It is an HIV prevention drug created and marketed by Gilead Sciences. Truvada also contains another anti-HIV drug called emtricitabine (FTC).
This combination of drugs comes in a generic form as a single pill. When these drugs are used as prescribed by doctors, the medications are known to be very effective at lowering the risk of contracting HIV. Random clinical trials were conducted with the medications and observed during various studies to get these conclusions.
As stated above, Truvada contains a mixture of medicines known as TDF. Since the release of the drug, some people have had a negative reaction to the formulation of tenofovir. Some patients noticed an increase in the risk of kidney injuries and bone density reduction. Gilead Sciences, the manufacturer of the Truvada drug, went on to develop TAF. Tenofovir alafenamide (TAF) is a new formulation of the drug tenofovir created to concentrate mostly on the immune system cells and is supposed to be a safer medication than TDF. Other medicines are formulated into the TAF pills. Descovy is the brand name that TAF and FTC are sold under.
Randomized Trials Held by Gilead Sciences
Gilead Sciences conducted a random clinical trial with a large group of users. The company sponsored a placebo-controlled portion of the trial, referred to as the Discover Trial. Within the trial, participants who were HIV-negative received a random pill to take once each day. The two pills randomly assigned included:
- Descovy (TAF)
- Truvada (TDF)
Each participant in the Discover trial was unaware of which pill formulation they were receiving during the first 96 weeks of the process. Once the first portion of the trial was completed, all participants were unblinded and offered only Descovy pills for the remainder of the clinical trial.
Participants included in the clinical trial:
- Gay men
- Bisexual men
- Around 1% were transgender women
The clinical trial has not finished and final results will not be in for some time. However, the company has released its interim results thus far. The number of cases of participants becoming HIV-infected was distributed according to formulations as follows:
- Descovy – 7 cases
- Truvada – 15 cases
According to the outcome of the two separate pill formulas, the statistics for HIV-infected participants were not significant. The results now show that both regimens are similarly effective and neither formulation is inferior to the other for reducing a person’s risk of being infected with HIV.
The study noted that additional tests were completed on blood samples taken from those who became infected while participating in the clinical trials. These additional analyses resulted in the conclusion that those infected were either not taking their drugs as directed or were infected at the beginning of the study. When these factors were considered, only a single person for each formulation became infected while taking the medication appropriately.
When it comes to safety, especially about bone thinning, there seems to be a clear favorite in the Descovy trial. Gilead Sciences is looking to gain regulatory approval to add Descovy to their packaging as a tool for users to reduce their risk of contracting HIV in Australia, Canada, the United States, and the European Union.
Details of Study
At the beginning of the study, the profiles of the trial participants were as follows:
The average age of all participants was 34 years old. The range of ages of participants in the clinical trial was between the ages of 18 and 72.
- 60% White
- 24% Hispanic
- 9% Black
- 5% Asian
To participate in a clinical trial, participants had to meet at least one of the following requirements:
- A documented history of contracting syphilis within the past 24 weeks
- A documented history of contracting chlamydia or rectal gonorrhea within the past 24 weeks
- Anal intercourse with two or more separate male partners without a condom within the last 12 weeks. The partners needed to be HIV positive or an unknown status for HIV.
Overall Results From Clinical Trial
The trial ended after 96 weeks. The following shows the overall HIV infection distribution between both formulas.
- Descovy – 7 infections
- Truvada – 15 infections
When reviewing the trial results, it was first thought that Descovy was reducing the risk of participants’ infections by more than 50%. Once researchers decided to analyze the blood samples and additional data they collected, it was found that many of the infections caused were a result of other possible factors, including:
- Poor Drug Adherence
- Descovy- Six of the infections found during the trial of participants using Descovy were found to be associated with the low levels of tenofovir found in their blood samples. The revelation suggests that those particular drug trial participants were not adhering to the guidelines on how to take Descovy each day.
- Truvada- Ten of the infections found during the trial of participants using Truvada were found to be associated with low levels of tenofovir in blood samples. The revelation suggests that those particular drug trial participants were not following the guidelines on how to take Truvada each day.
At the beginning of the trial, researchers expected there would be at least four infections from the group of participants taking Truvada and at least one infection from the participants taking Descovy.
Bone Mineral Density Changes
In the end, around 383 drug trial participants were tested for changes in their bone mineral density. Those who were taking Descovy were found to have small increases of this density in their spine and hips. This was assessed using an X-Ray scan that is low-dose called DEXA or dual-energy X-ray absorptiometry. For the users of Truvada, the increase was only around 1%.
Descovy users who were seen to have an increase in bone mineral density were young men in their early 20s or late teens and were still going through natural bone density changes. Descovy was not found to harm their natural bone density development.
What Do These Results Show?
For Descovy, the trial results are encouraging and have been shown to be as similarly effective as Truvada when lowering the risk of contracting HIV. However, it was found that Descovy had an advantage for bone density health. Over the course of the whole trial, Truvada users had a decrease in bone density and most Descovy users had an increase. It was clear that all users were essentially safe from kidney issues, but there does appear to be a modest degree of injury caused to the kidneys when used for extended periods of time. Because of this, more data is being eagerly awaited from the Discover trials.
Lawsuits Against Gilead Sciences
Patients who have taken Truvada and have been injured are filing lawsuits against Gilead, alleging that the company has purposely delayed the newer treatment (Descovy) so the company could continue to profit on its lucrative, older franchise, Truvada.
If you or a loved one has suffered any of the severe side effects of Truvada mentioned above, contact the Truvada drug injury lawyers at The Eichholz Law Firm. Our experienced legal team has years of experience in handling dangerous drug lawsuits.
Call 855-551-1019 or fill out an online form for a free consultation. Please note that The Eichholz Law Firm is only accepting Truvada with TDF cases and not TAF (Descovy) cases.
- Molly Walker. “Truvada Meets Its Match for PrEP”, MedPage Today, https://www.medpagetoday.com/meetingcoverage/croi/78422. Accessed August 25, 2019.
- Hill et al. “Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety?”, Journal of Virus Eradication, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5892670/. Accessed August 25, 2019.