Gilead Presents 96-week Discover Trial Data Supporting Non-inferior Efficacy and Key Safety Differences of Descovy For PrEP™ Compared With Truvada For PrEP®
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov 6, 2019--
Gilead Sciences, Inc. (NASDAQ: GILD) today announced 96-week results from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for HIV pre-exposure prophylaxis (PrEP) compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for PrEP, in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection. Descovy demonstrated non-inferior efficacy to Truvada through 96 weeks and statistically significant differences over Truvada for certain key measurements of bone and renal safety assessed in the study, which were pre-specified secondary endpoints. These data are being presented at the 17 th European AIDS Conference (EACS) in Basel, Switzerland.
“The 96-week data from the DISCOVER trial further support the comparable efficacy of Descovy and Truvada for PrEP and offer new insights into the improved renal and bone safety profile of Descovy as measured by key bone and renal markers,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “As more at-risk people use PrEP for longer periods of time, the data affirm the value of Descovy for PrEP as a new HIV prevention option.”
In the United States, Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
Descovy has a Boxed Warning in its U.S. product label regarding the risk of drug resistance when used for PrEP in undiagnosed early HIV infection, and the risk of post-treatment acute exacerbation of hepatitis B. See below for Indication and Important Safety Information.
In the DISCOVER trial, 5,387 study participants were randomized in a 1:1 ratio to receive either Descovy or Truvada once-daily. The primary endpoint was the incidence rate of HIV infection when 100 percent of participants completed 48 weeks, and at least 50 percent of participants completed 96 weeks. As a secondary endpoint analysis, the incidence rate ratio (IRR) of Descovy to Truvada was evaluated when 100 percent of participants completed 96 weeks. Among the 2,670 participants who received Descovy over 96 weeks, eight acquired HIV (incidence rate: 0.16/100 person-years (PY)). Among the 2,665 participants who received Truvada for the duration of the study, 15 acquired HIV (incidence rate: 0.30/100 PY). These results confirm the continued non-inferiority of Descovy versus Truvada (IRR: 0.54; 95 percent CI 0.23, 1.26). After the primary analysis, there was one new HIV infection in the Descovy arm in a study participant with significantly reduced adherence for several months.
Bone and Renal Safety Outcomes
Bone mineral density (BMD) was measured in a subset of 375 participants at 96 weeks. For measurements of both spine and hip BMD, differences between the Descovy and Truvada arms were statistically significant. At Week 96, lumbar spine BMD increased by 0.95 percent in the Descovy group and decreased by 1.39 percent in the Truvada group (p<0.001). Increases in hip BMD were also observed in participants taking Descovy, with an increase of 0.65 percent from baseline. Among those taking Truvada, hip BMD decreased by 1.01 percent (p<0.001).
For measurements of renal safety, statistically significant differences at Week 96 were observed favoring Descovy in mean serum creatinine level, median creatinine clearance and markers of proximal tubular function (β2-microglobulin:creatinine ratio and retinol binding protein:creatinine ratio) (p<0.001 for all markers). Week 96 data also demonstrated fewer cases of treatment-emergent proteinuria among patients taking Descovy than among those taking Truvada (p=0.003) and similar changes in urine protein:creatinine ratio across the two treatment groups (p=0.22).
“These findings give healthcare providers and their patients a deeper understanding of the differences in the renal and bone safety profile of Descovy for PrEP as compared with Truvada,” said Peter Ruane, MD, Ruane Medical and Liver Health Institute. “Descovy for PrEP provides appropriate at-risk people with a new HIV prevention option that can potentially address important safety considerations related to bone mineral density and kidney function.”
Sexually transmitted infections (STIs) were assessed in three anatomic sites (oropharynx, urethra, rectum) at each study visit. Results of these STI screenings demonstrate that participants maintained high-risk sexual risk behavior from study entry through the duration of the study. At 96 weeks, 59 percent of participants had been diagnosed with gonorrhea or chlamydia (from any anatomic site) and 15 percent had been diagnosed with syphilis. All received medical treatment and contact tracing as appropriate.
Study drug-related adverse events were similar in both arms and adverse event-related discontinuations were uncommon, occurring in less than two percent of each arm. Of the nine adverse events that occurred at a frequency of at least 10 percent in either study arm, six of the nine were sexually transmitted infections. The others were diarrhea, nasopharyngitis, and upper respiratory tract infection.
Gilead has committed to conducting a clinical trial that will evaluate the safety and efficacy of Descovy for PrEP in cisgender women and adolescent females weighing at least 35 kg and who are at risk of sexually acquired HIV-1 infection in Africa.
Descovy does not prevent other sexually transmitted infections or cure HIV or AIDS.
Important U.S. Safety Information and Indication for Descovy for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
DESCOVY for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving Descovy for PrEP. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
U.S. full Prescribing Information for Descovy and Truvada, including BOXED WARNINGS, is available at www.gilead.com
Descovy, Descovy for PrEP, Truvada, Truvada for PrEP and Gilead are trademarks of Gilead Sciences, Inc. or its related companies.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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SOURCE: Gilead Sciences, Inc.
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PUB: 11/06/2019 06:45 AM/DISC: 11/06/2019 06:45 AM