Truvada is a medication containing two anti-HIV drugs, tenofovir disoproxil fumarate (TDF) and emtricitabine, known as FTC. There are generic formulations of this combination found in a single pill. Randomized clinical trials and observational studies have been conducted in which Truvada, when used as prescribed, proved to effectively lower the risk of contracting HIV.
It has come to light that, unfortunately, the TDF found in Truvada is responsible for increasing the likelihood of kidney injury and also bone-thinning in some individuals. Truvada’s manufacturer, Gilead Sciences, now has a newer formulation of tenofovir called tenofovir alafenamide, or TAF. The newer formulation seems to have a better safety profile than TDF, and it beneficially collects inside immune system cells. TAF is combined with other drugs and put into a single pill. TAF and FTC are combined together to form a brand name medication called Descovy.
Gilead Sciences sponsored the Discover Trial, a placebo-controlled clinical trial with a large group of participants randomly selected and HIV-negative. The participants would be given either Descovy or Truvada for 96 weeks. Participants were not informed which of the two drugs they were given. After the 96 weeks were completed, all participants were given the option to take Descovy. Of the 5,387 participants, most of them were gay or bisexual men, with about 1 percent being transgender women. The ongoing study produces interim results periodically.
In March 2019, much-awaited results of the trial were presented at the Conference on Retroviruses and Opportunistic Infections, or CROI. An HIV specialist from Kaiser Permanente presented the results. Of the nearly 2,700 participants at risk of acquiring HIV who took Truvada during the trial period, 15 individuals contracted HIV. Contrast that to the nearly 2,700 participants at risk who took Descovy once a day, and only seven HIV infections developed. The result of comparing the two drugs shows that both medications are similarly effective in reducing the risk of acquiring an HIV infection.
When further analysis was done on the blood samples of participants who acquired HIV during the trial, results showed that the majority of them either did not take the medication as directed, or they became infected very early, maybe within hours of their initial screening. When this data was factored in, and these individuals were excluded, the results showed that only one person from the Truvada group and one person from the Descovy group became infected during the trial.
Statistics and Requirements of Discover Trial
At the trial’s start, the participants’ were:
- Ethnic groups – White 60%; Hispanic 24%; Asian 5%; Black 9%
- Average age – 34 (ages ranged from 18 – 72)
Each participant must have had at least one of the following:
- History of syphilis in the past 24 weeks (documented)
- History of rectal gonorrhea or chlamydia in the past 24 weeks (documented)
- Condomless, anal intercourse with at least two different male partners in the past 12 weeks (with each partner either HIV positive or of unknown HIV status)
Truvada – Upon further analysis of the 10 Truvada participants who became HIV-infected during the trial, it was discovered that the levels of tenofovir in their bloodsteam were lower than they should have been, suggesting that Truvada had not been taken regularly every day.
Descovy – The six Descovy users who became infected with HIV showed a lower level of tenofovir in their bloodstreams than would have been present had they regularly taken Descovy as prescribed.
One significant difference between the two medications did emerge, however, in the area of bone thinning. Truvada use may cause bone pain, thinning, and softening that can further lead to fractures. Descovy is clearly the favored medication over Truvada in this arena. Descovy’s manufacturer, Gilead Sciences, will be asking for approval to distribute the drug in Canada, the European Union, the United States, and Australia by late 2019 for use in a consortium of tools to reduce the risk of spreading HIV.
Density Changes in Bone Mineral
Through the use of dual-energy X-ray absorptiometry, also called DEXA, 383 Discover Trial participants were evaluated with low-dose X-rays to determine if any bone mineral density changes had occurred from taking the medications. Participants taking Descovy saw a slight increase in bone density in the spine and hip areas. However, the Truvada users were not so fortunate. Their X-rays revealed about 1% bone density loss.
One explanation emerged with regard to the bone density increase for Descovy users. Because many of them fell into the age group between late teens to early 20s, their bones were in a natural stage of growth and development anyway. It is only natural that they would experience increased bone density. The good news seems to be that there was no harm done to their bone development as a result of taking Descovy.
Meaning of the Results
While it appears that Descovy and Truvada similarly help prevent infection from HIV, the advantage of Descovy is that it exhibits the ability to increase the density of bone minerals in users. Truvada does just the opposite.
Secondly, the Discover Trial seems to indicate that kidney safety with Truvada is good. However, it remains to be seen whether long-term use may lead to kidney injury as a side effect. As time goes on and more data is released from the Discover trial, further light will be shed.
Legal Suits Against Truvada Manufacturer
Lawsuits are being filed against Gilead Sciences by Truvada patients who, among other things, allege the manufacturer delayed releasing Descovy in order to continue profiting from Truvada sales. Broughton Partners helps personal injury attorneys connect with signed Truvada lawsuit leads who are seeking legal representation for a Truvada lawsuit.
Call (912)-304-4444 to learn more about our services or complete an online form to receive a free consultation. Please note that Broughton Partners only reviews Truvada with TDF lawsuit plaintiffs, not Descovy (TAF) plaintiffs.
- 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.