Business Wire

Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance

Share

Gilead Sciences, Inc. (NASDAQ: GILD) today presented findings from two Phase 3 trials – a trial demonstrating the effectiveness of switching to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) in women, and a trial evaluating the potential for the single tablet regimen to be an effective treatment option in virologically suppressed patients with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse transcriptase inhibitors (NRTIs or NNRTIs). The use of Biktarvy in patients with known drug resistance is investigational. These data were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City.

“These data presented at IAS provide new information about the treatment of HIV among women and patients with known drug resistance,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “The studies further demonstrate the potential for Biktarvy to be an important treatment option for appropriate patients.”

In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral treatment history. While Biktarvy is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable antiretroviral regimen, these patients must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. On June 18, 2019, the U.S. Food and Drug Administration (FDA) approved labeling revisions to Biktarvy, expanding the patient population to include HIV-1 infected pediatric patients weighing at least 25 kg. Biktarvy has a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.

Key abstracts for Biktarvy data presented at IAS 2019 include:

Oral Presentation MOAB0106: Longer-term (96-week) efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in women

This international multicenter, randomized, open-label Phase 3 trial evaluated 470 virologically suppressed women on a baseline regimen of either Genvoya® (elvitegravir/cobicistat/F/TAF; 150/150/200/10 mg), elvitegravir/cobicistat/F/TDF (150/150/200/300 mg) or atazanavir+ritonavir+F/TDF (300+100+200/300 mg) who switched 1:1 from these baseline regimens to Biktarvy. The primary endpoint for this study conducted exclusively in women, was previously presented, and demonstrated noninferior maintained virologic suppression, with a low frequency of serious adverse events and no emergent resistance at Week 48. All participants, including those on baseline regimens, switched to Biktarvy through Week 96.

At Week 96, 99.5 percent of women who received Biktarvy throughout the study duration and 98.5 percent of women who switched to Biktarvy at Week 48 maintained virologic suppression (missing=excluded; M=E), with no development of treatment-emergent resistance. Biktarvy was also shown to be well-tolerated with low frequencies of serious adverse events.

“Despite the fact that women account for the majority of new HIV infections globally, they remain largely underrepresented in HIV clinical trials,” said Cissy Kityo, MD, Executive Director, Joint Clinical Research Centre in Uganda, and lead study investigator. “The findings from this study conducted exclusively in women yield important long-term data on the safety, tolerability and efficacy of Biktarvy in this important patient population.”

Oral Presentation MOAB0105: Switching to a single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG) plus emtricitabine and either tenofovir alafenamide or tenofovir disoproxil fumarate (F/TAF or F/TDF)

This ongoing, randomized, double-blinded Phase 3 study evaluated 565 virologically suppressed adults who switched 1:1 from a regimen of DTG+F/TAF (50+200/25 mg) or DTG+F/TDF (50+200/300 mg) to DTG+F/TAF or Biktarvy for 48 weeks. Unlike previous studies – which excluded participants with known resistance – participants in this study with prior resistance to NRTIs, NNRTIs and/or protease inhibitors (PIs) could enroll. Only those participants with documented integrase inhibitor resistance were excluded, and 24 percent of participants had resistance to NRTIs. The study’s primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 c/ml at Week 48.

At Week 48, 0.4 percent (n=284) of participants on Biktarvy had HIV-1 RNA ≥ 50 c/ml, compared to 1.1 percent of participants on DTG+F/TAF (n=281) (snapshot algorithm), demonstrating noninferiority. In addition, at Week 48, no treatment-emergent resistance was detected, and no participants with pre-existing NRTI resistance mutations had HIV RNA >50 c/mL.

The use of Biktarvy in patients with known drug resistance is investigational and has not been determined to be safe or efficacious and is not approved by the U.S. FDA.

Biktarvy does not cure HIV infection or AIDS.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Biktarvy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use Biktarvy with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Biktarvy therapy and monitor for adverse reactions.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of Biktarvy, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Biktarvy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Biktarvy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 96 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of Biktarvy during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

Dosage and administration

  • Dosage: 1 tablet taken once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

INDICATION

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy.

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 nearly 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.

Forward-Looking Statement

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 Biktarvy. 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 March 31, 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 Biktarvy and Genvoya, including BOXED WARNINGS, is available at www.gilead.com.

Biktarvy, Genvoya, Gilead and the Gilead logo 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.

Contact information

Sung Lee, Investors
(650) 524-7792

Ryan McKeel, Media
(650) 377-3548

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

c-LEcta: Successful Product Business in the First Half of 201922.8.2019 11:06:00 EESTPress release

c-LEcta, a globally active biotechnology company with technology leadership in enzyme engineering and bioprocess development, successfully expanded its product business in the first half of 2019. Besides sales increases across the entire portfolio, the company was granted many new patents. While the patent portfolio still comprised 59 granted patents at the end of the first half of 2018, the Leipzig-based company now holds more than 80 patents. c-LEcta’s DENARASE®, which is used for the necessary removal of nucleic acids from biopharmaceutical products, performed particularly well. DENARASE® is the most efficient technology on the market for meeting the stringent regulatory requirements for biopharmaceutical products. Sales of this product increased by 164% year-on-year in the first half of 2019. The other products in c-LEcta’s portfolio also performed very well and contributed to the positive development of the product business. c-LEcta now markets its self-developed products in 25 co

MobileIron Named a Leader Again in the Second Gartner Magic Quadrant for Unified Endpoint Management Tools22.8.2019 10:00:00 EESTPress release

MobileIron (NASDAQ:MOBL), the company that introduced the industry’s first mobile-centric, zero trust platform for the enterprise, today announced that it has been positioned as a Leader for the second consecutive year in the Gartner Magic Quadrant for Unified Endpoint Management Tools. The report evaluated 11 vendors based on completeness of vision and ability to execute. “To us, it’s an honor to be recognized once again as a Leader in Gartner’s Magic Quadrant for Unified Endpoint Management Tools,” said Simon Biddiscombe, CEO, MobileIron. “We have continued to innovate and expand upon our UEM platform to keep up with the demands of today’s digital businesses. Earlier this year, we introduced a revolutionary zero sign-on experience to eliminate passwords and make the world’s most ubiquitous product – the mobile device – your ID and secure access to the enterprise built on our leadership foundation in UEM. Mobile and cloud technologies have driven a dramatic change in organizations acr

Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System22.8.2019 09:00:00 EESTPress release

Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions and recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with anterior STEMI heart attacks. The Centers for Medicare & Medicaid Services (CMS) also recently acknowledged the importance of this designation by establishing an alternative reimbursement pathway for products that receive FDA marketing authorization and held the Breakthrough Designation. PiCSO therapy is provided by interventional cardiologists during PCI (Percutaneous Coronary Intervention) in patients experiencing ST-elevated myocardial infarction (STEMI). The PiCSO Impulse System clears the coronary microcirculation by intermittently

Mori Building Unveils Massive Urban Regeneration Project in Central Tokyo22.8.2019 07:00:00 EESTPress release

Mori Building Co., Ltd., a leading urban landscape developer, has begun construction on its “Toranomon-Azabudai District Category 1 Urban Redevelopment Project,” a massive urban regeneration project aimed at revitalizing a large area of central Tokyo. A groundbreaking ceremony was held on August 5 and project completion is scheduled for the end of March 2023. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005445/en/ Image of Office Lobby (Graphic: Business Wire) The core concept of the Toranomon-Azabudai Project is that of a “Modern Urban Village,” a unique neighborhood that will combine the sophistication of a megalopolis with the intimacy of a small village in the heart of Tokyo. It will cover an area of approximately 8.1 hectares, similar to that of New York’s Rockefeller Center, and will feature extensive greenery totaling 24,000 m2 including a 6,000 m2 central square. Total floor area will be 860,400 m2, including

Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency22.8.2019 02:01:00 EESTPress release

STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM). The submission is based on the results from the landmark Phase III CREDENCE study1 which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care. “Chronic kidney disease is a serious complication of type 2 diabetes, which can increase patients’ risk of developing end-stage renal disease and may reduce their life expectancy by several years.” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma. “If approved, this licence

Triton Digital Releases Webcast Metrics Rankings for the Top Digital Audio Properties for April 201921.8.2019 23:00:00 EESTPress release

Triton Digital®, the global technology and services leader to the digital audio and podcast industry, released today its monthly Webcast Metrics® rankers for April 2019. The global rankers, in addition to the U.S., LATAM, and EMEA regional rankers provide insight into the top-performing streaming audio stations and networks around the world for the month of April. The full results of the Global & Regional Rankers for April 2019 can be found here: https://www.tritondigital.com/resources/monthly-rankers/rankers-archive The Webcast Metrics streaming measurement service is the industry standard for online audio consumption data. It provides credible, validated data that enables audio publishers around the world to analyze the consumption of their audio content by daypart, device type, geography, distribution platform, and more. About Triton Digital Triton Digital® is the global technology and services leader to the digital audio and podcast industry. Operating in more than 40 countries, Tr

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom