Truvada is the name of a medication that contains two anti-HIV drugs. The combination includes emtricitabine (FTC) and tenofovir disoproxil fumarate, known as TDF. This mixture can also be found in generic formulations within one pill. In observational studies and randomized clinical trials, Truvada was found to be very effective in lowering an individual’s risk of contracting HIV if the medication was used as prescribed.
The formulation of TDF contained in Truvada has been found to increase the potential for kidney injury, and in some people, the use of this formulation is linked with thinner-than-normal bones. Gilead Sciences, the manufacturer of Truvada, has created a newer formulation of the drug tenofovir, now called TAF or tenofovir alafenamide. This formula collects inside the immune system cells and looks to have a better profile of safety than TDF. The newer drug, TAF, is also combined in one pill with other medications. The combination of TAF and FTC is marketed under the brand name Descovy.
Trials to Compare Truvada and Descovy
The Discover trial, sponsored by Gilead Sciences, is a large randomized placebo-controlled clinical trial with participants who are HIV-negative individuals who were randomly selected to receive either Truvada or Descovy. For 96 weeks, none of the participants knew which of the two medications they were being given. After this time period was over, everyone participating was offered Descovy. The 5,387 participants are mostly bisexual or gay men, and approximately 1% are transgender women. The study is still being conducted, but interim results are available.
At the Conference on Retroviruses and Opportunistic Infections (CROI) held in March 2019, long-awaited results were revealed. According to the Kaiser Permanente HIV specialist who presented the results, 15 out of the 2,693 individuals at risk of getting HIV-1 who were given Truvada during the clinical trial, contracted HIV infections. Of the 2,694 people at risk who were given the once-daily Descovy, seven infections were reported. Thus, Descovy met the criteria for non-inferiority to Truvada that had been pre-established. Basically, the results showed this: when the effectiveness of each drug is compared, both Truvada and Descovy are similarly effective at lowering the risk of contracting an HIV infection.
It should be noted that further analysis was completed on blood samples from individuals who contracted HIV during the study. It was determined that most of them had either gotten infected at the beginning of the study, possibly within hours of the initial screening, or that they had not taken the medication exactly as directed. When factoring in this information and excluding such individuals from the analysis, the data shows that only two participants became infected, one from each of the medications.
There is a difference between the two drugs, however, when it comes to bone thinning. Descovy is clearly favored over Truvada in this area. The manufacturer, Gilead Sciences, will be seeking approval to use Descovy in Australia, the European Union, Canada and the United States in late 2019 as part of a bundle of tools to help reduce the risk of HIV spreading.
Details of Discover Trial
The profile of participants at the beginning of the study was:
- Average age – 34 years old (ranging from 18 to 72)
- Ethnic groups – White 60%; Black 9%; Hispanic 24%; Asian 5%
The requirement for each participant was at least one from this list:
- Documented history of rectal gonorrhea or chlamydia in the past 24 weeks
- Documented history of syphilis in the past 24 weeks
- Anal condomless intercourse with at least two separate male partners in the past 12 weeks (each partner must be of unknown HIV status or HIV positive)
Breakdown of Results
Initially, Descovy appeared to lower the risk of HIV infection by 50%. However, researchers later analyzed blood samples from participants, along with other data, and discovered that most of the infections surfacing during the clinical trial had likely resulted from poor adherence to the medicine routine, or were infections contracted right around the time of initial screening.
- Descovy – Six infections were ruled to be the result of a lower level of tenofovir in the bloodstream than ideal, leading to the conclusion that participants had not taken Descovy every day.
- Truvada – Likewise, 10 infections were linked to lower levels of tenofovir in the bloodstream, suggesting these participants did not take Truvada every day.
Bone Mineral Density Changes
Approximately 383 participants in the Discover clinical trial were later evaluated for any alterations in bone mineral density. By using low-dose X-ray technology known as DEXA (dual-energy X-ray absorptiometry), it was determined that Descovy users experienced a slight increase in bone mineral density in the area of their hips and spine during the clinical trial period. However, Truvada users went in the opposite direction, showing about 1% loss in bone mineral density.
An explanation ensued concerning the Descovy bone density increase when it was factored into the mix that many of the participants using this drug were between the ages of late teens to early 20s, and their bones were still growing and developing. There would naturally have been an increase in bone density anyway. However, it is significant to note that their bone development does not seem to have been harmed by Descovy.
What’s the Meaning of the Results?
Truvada and Descovy appear to be similarly effective in preventing HIV infection. The advantage that Descovy has, however, stems from its ability to increase bone mineral density, while Truvada does the opposite. In the Discover clinical trial, Truvada’s kidney safety factor seems to be good, but kidney injury may be a side-effect of long-term use. Further data from the Discover trial is expected to shed more light and is eagerly awaited.
Lawsuits Against Truvada Drugmaker
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 KBA Attorneys. Our experienced legal team has years of experience in handling dangerous drug lawsuits.
Call 855-281-2571 or fill out an online form for a free consultation. Please note that KBA Attorneys 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.