China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
In the United States, Descovy has a boxed warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. See below for U.S. important safety information, indication, and limitations of use.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF (tenofovir disoproxil fumarate 300 mg) but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, TAF demonstrated improved renal and bone laboratory safety parameters compared to TDF.
“Advances in HIV therapies have changed the way physicians think about long-term care. As the number of people aging with HIV continues to grow, it is critical that treatments are designed to help address evolving health needs,” said Professor Li Taisheng, Peking Union Medical College Hospital. “As an effective HIV treatment backbone with a demonstrated renal and bone safety profile, Descovy may help support the long-term needs of a range of appropriate patients living with HIV.”
In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003.
“With this approval, Descovy joins Genvoya® as another TAF-based treatment option available in China to help address the needs of people living with HIV,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “The components of Descovy, used together with other antiretroviral agents as part of either a single or multi tablet regimen, offer physicians and patients an effective treatment combination that has the potential to improve health.”
The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.
The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents.
Descovy received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2016. In the U.S., only the emtricitabine 200 mg/tenofovir alafenamide 25 mg dosage form is approved.
Descovy does not cure HIV infection or AIDS.
U.S. Important Safety Information for Descovy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Descovy is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Descovy have not been established in patients coinfected with HIV-1 and HBV. 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 and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Descovy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Descovy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Warnings and precautions
- 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 emtricitabine and tenofovir
alafenamide with elvitegravir and cobicistat, there have been no cases
of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not
initiate Descovy 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 Descovy in patients who
develop clinically significant decreases in renal function or evidence
of Fanconi syndrome.
Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including emtricitabine and TDF. Discontinue Descovy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
- Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).
- Prescribing information: Consult the full prescribing information for Descovy for more information on potentially significant drug interactions, including clinical comments.
- Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of Descovy. Drugs that induce P-gp can decrease the concentrations of components of Descovy, which may lead to loss of efficacy and development of resistance.
- Drugs affecting renal function: Coadministration of Descovy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients weighing at least 35 kg: 1 tablet taken orally once daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30 mL/min.
- Testing prior to initiation: Test patients for HBV infection and assess CrCl, urine glucose and urine protein.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of Descovy during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established; available data from the APR for emtricitabine shows no difference in the rates of birth defects compared with a U.S. reference population.
- Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
U.S. Indication for Descovy
Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.
Limitations of Use:
Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.
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 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 risk that physicians may not see the benefits of prescribing Descovy for the treatment of HIV-1 infection and the possibility of unfavorable results from ongoing and additional clinical trials involving Descovy. 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, 2018, 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, Genvoya, and Stribild, including BOXED WARNINGS is available at www.gilead.com .
Descovy, Genvoya, and Stribild are registered 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.
Sung Lee, Investors
Sonia Choi, Media
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Secure-D Exposes Suspicious Android App with 500 Million Downloads22.5.2019 16:49:00 EEST | Tiedote
Upstream, a leading mobile technology company, has unveiled that the popular Android application VidMate triggers suspicious background activity. Hidden software within the app delivers invisible ads, generates fake clicks and purchases, installs other suspicious apps without consent and collects personal users’ information. Consequently, it depletes users’ data allowance and brings unwanted charges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005501/en/ With over 500 million downloads reported, VidMate is a popular Android application for streaming and downloading videos and songs from services such as Dailymotion, Vimeo, and YouTube. It is not available in the Google Play Store but is distributed through third-party app stores like CNET or Uptodown. According to publicly available information, VidMate was developed by a subsidiary of UC Web, which is owned by Chinese conglomerate Alibaba. Over a recent period Upst
Airship’s Data Study Reveals the State of Global Mobile Permissions One Year into GDPR22.5.2019 16:35:00 EEST | Tiedote
With GDPR reaching its one year anniversary May 25, customer engagement company Airship today revealed top-level results of its global benchmark study, examining the state of mobile app user permissions across nearly 700 million people worldwide. While marketers trimmed customer lists to meet new regulatory requirements for "traditional" channels (i.e., email), mobile app audiences continue to grow — up globally by +16.6 percent year over year. Businesses are also sending more notifications — averaging 36 per user per month (up 18.4 percent since last year) — while the average notification opt-in rate remains high at over two-thirds (67 percent) of global app users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005486/en/ With mobile app audiences growing around the world, businesses are more heavily leveraging notifications with negligible impact to opt-in rates. (Graphic: Business Wire) These metrics vary at a regio
Diligent Launches Modern Governance to Address Dangerous Governance Deficits and Announces New Modern Governance Summit22.5.2019 16:27:00 EEST | Tiedote
Today, Diligent Corporation launched a new category, called modern governance, designed to provide leaders with the missing key to bring governance into the digital age, along with new technology and a summit to support this well-designed system. Modern governance is the practice of empowering leaders with technology, insights, and processes to fuel good governance that organizations require to thrive and endure. Modern governance helps organizations address governance deficits. A governance deficit means an organization lacks the security, foresight, and accountability to withstand the onslaught of contemporary challenges – such as activist investors, cyber risk, regulation, diversity and global uncertainty. Feedback from Diligent’s 16,000 clients and the 600,000 leaders who use its technology – including more than 50% of the Fortune 1000, 70% of the FTSE 100, and 65% of the ASX – sparked the need for rethinking how companies and their boards should approach governance to navigate tod
Wipro Builds a Blockchain-Based Solution for Travacoin to Enable Digital Currency-Based Payments for the Airline Industry22.5.2019 15:19:00 EEST | Tiedote
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting, and business process services company, today announced that it has developed a blockchain-based payment solution for Travacoin, a company specializing in an eponymous digital payment solution. Travacoin is a digital payment system which enables airlines to refund and compensate passengers in a timely manner when a disruption occurs. Passengers will be notified of a delay or cancellation and refunded in this digital currency, which can be used to repurchase airline tickets, book hotels and avail other airport and travel related services. Passengers will benefit by way of a significant reduction in the waiting time for compensation. In addition, passengers can use Travacoins at retail stores in and around the airport and avail attractive discounts offered by retail partners. By compensating passengers with Travacoins, airlines will be able to reduce their administrative overheads and
New Fluid Dispensing Guide for Stock Lubrication and Metal Stamping from Nordson EFD22.5.2019 15:15:00 EEST | Tiedote
Nordson EFD , a Nordson company (NASDAQ: NDSN), the world’s leading precision fluid dispensing systems manufacturer, has released a new solutions guide for stock lubrication and metal stamping. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005010/en/ The Stock Lubrication Solutions Guide is an overview of how Nordson EFD’s MicroCoat® lubrication system provides more consistent oil coverage and significantly reduces oil waste by up to 90%. By doing so the system quickly pays for itself by extending tool life and reducing oil usage, thus lowering waste disposal costs. In the guide, eight MicroCoat customers share application details that illustrate the benefits of the system’s Low Volume Low Pressure (LVLP) technology. Each customer has a different application with different problems to solve. “Our MicroCoat system is truly the first stock lubrication system to provide consistent oil coverage without overspray,” said Cl
Altasciences Leads Research on Chemical Nerve Agent Therapeutic from Preclinical to Clinical Phase I22.5.2019 15:04:00 EEST | Tiedote
Altasciences announced today that they have been selected by Leidos Health to guide and support the development of RAP-103 peptide as a chemical nerve agent therapeutic on behalf of the Medical CBRN Defense Consortium and funded by the Defense Threat Reduction Agency (DTRA). Altasciences will conduct the required Safety Testing, all IND-enabling studies (non-GLP and GLP), the necessary Phase I clinical trials, and associated bioanalytical analysis. “Altasciences’ preclinical and clinical teams are collaborating with Leidos Health on this important program. Together, we have developed a plan to move RAP-103 from preclinical, safely through early clinical trials. As a mid-size CRO specializing in a flexible, innovative approach to providing comprehensive early stage drug development, we have the experience and team in place to complete this program successfully, on time and within budget,” explained Steve Mason, Vice President, Site Operations, at Altasciences. For over 25 years, Altasci
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme