Gilead Sciences to Provide Free Truvada for PrEP® to Support U.S. Initiative to End the HIV Epidemic
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will donate Truvada for PrEP® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) to the U.S. Centers for Disease Control and Prevention (CDC) in support of national efforts to help prevent HIV and end the epidemic. This medication donation is among the largest ever in the United States and is part of Gilead’s broader ongoing initiatives to help ensure that everyone who can benefit from PrEP is able to access it. Gilead will provide to CDC up to 2.4 million bottles of Truvada® annually for uninsured Americans at risk for HIV. The donation, which extends up to 2030, will transition to Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets), if it is approved for use as PrEP.
Approximately 200,000 of the estimated 1.1 million Americans who are at risk for HIV currently receive Truvada for PrEP. Broader usage among at-risk populations is hampered by significant social and structural barriers, such as HIV stigma, homophobia, limited awareness of PrEP among providers and patients, and overall lack of access to healthcare. Gilead’s donation will support a greatly accelerated effort to reach these individuals, as well as create an opportunity for state and local partnerships to develop and implement protocols that are intended to ensure uninsured people at risk for HIV are given access to PrEP at no cost.
“We are proud to partner with CDC to dramatically expand access to medication that can help prevent new HIV infections,” said Gregg Alton, Chief Patient Officer, Gilead Sciences. “We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease.”
Following five years of declines, the annual number of new HIV diagnoses has remained stable in the United States since 2013. During 2016 and 2017, half of new diagnoses concentrated in 48 “hotspot” counties as well as Washington, D.C., and Puerto Rico.
In the U.S., Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh ≥35 kg. Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg and is not approved for PrEP anywhere globally. The use of Descovy for an HIV PrEP indication is investigational and has not been determined to be safe or efficacious.
Gilead submitted a supplemental New Drug Application (sNDA) for Descovy for PrEP to the U.S. Food and Drug Administration (FDA) on April 5, 2019. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.
Descovy and Truvada each have a Boxed Warning in their respective product labels regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection. See below for Important Safety Information and complete Indications.
Beyond the donation, Gilead’s commitment to combating the HIV/AIDS epidemic includes the COMPASS (COMmitment to Partnership in Addressing HIV/AIDS in Southern States) Initiative™. COMPASS is a 10-year, $100 million commitment to address the HIV/AIDS epidemic in the South through capacity building, mental health and trauma-informed care, and awareness and anti-stigma education.
Gilead has longstanding patient support programs in the U.S. to help eligible individuals with financial need to access Truvada for PrEP. For commercially insured, eligible individuals, Gilead provides copay coupon support, through which patients may pay as little as $0 per bottle for Truvada for PrEP. Those without insurance may be able to access Truvada for PrEP free of charge through our longstanding Medication Assistance Program or, in the near future, through the new CDC-Gilead partnership. Individuals who would like to learn more about support programs that may be available to them are encouraged to visit the Gilead Advancing Access® website at www.gileadadvancingaccess.com.
In addition, many government healthcare programs receive significant discounts on Gilead medicines. For HIV, for example, state Medicaid programs receive discounts on the company’s products. Gilead established a price freeze for all of the company’s HIV medications for state AIDS Drug Assistance Programs (ADAPs) in 2008, which remains in effect through 2019. ADAPs also receive supplemental discounts.
Important U.S. Safety Information and Indication for Truvada for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Truvada for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of Truvada for PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
- Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
- Do not use Truvada for PrEP in individuals with unknown or positive HIV status.
Warnings and precautions: Comprehensive risk reduction strategies
- Reduce HIV-1 risk: Truvada for PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, and counseling on reducing sexual risk behaviors.
- Reduce potential for drug resistance: Truvada for PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking Truvada, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only Truvada. Truvada alone is not a complete regimen for treating HIV-1.
- HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by U.S. Food and Drug Administration (FDA) for the diagnosis of acute HIV infection.
- If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed.
- Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling.
Warnings and precautions
- New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). Truvada is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration.
- Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.
- Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including Truvada. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
- Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of Truvada and monitor for adverse reactions.
- Common adverse reactions (>2% and more frequently than placebo) of Truvada for PrEP in clinical trials were headache, abdominal pain, and weight loss.
- Prescribing information: Consult the full Prescribing Information for Truvada for more information, warnings, and potentially significant drug interactions, including clinical comments.
- Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions.
- Drugs affecting renal function: Coadministration of Truvada with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.
Pregnancy and lactation
- Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for Truvada compared with a U.S. reference population. Consider HIV prevention methods, including Truvada for PrEP in at-risk women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection.
- Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of Truvada for PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of Truvada on the child, which are unknown.
Dosage and administration
- Dosage: One tablet once daily with or without food.
- HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment.
- HBV screening: Test for HBV infection prior to or when initiating treatment.
- Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus.
Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
- If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by FDA to aid in the diagnosis of acute HIV-1 infection.
Individuals at risk for sexually acquired HIV-1 may include those:
- With HIV-1 infected partner(s), or
- Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors.
Important U.S. Safety Information and Indication for Descovy for HIV Treatment
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 (FTC) 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 FTC 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 FTC 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 who weigh ≥25 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.
- Pediatrics: The safety and effectiveness of Descovy coadministered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg.
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 FTC 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.
Descovy is indicated in combination with other antiretroviral (ARV)
agents for the treatment of HIV-1 infection in patients weighing at
least 35 kg.
Descovy is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 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.
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 FDA and other regulatory agencies may not approve Descovy for PrEP in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Descovy for PrEP may never be successfully commercialized. 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 Descovy and Truvada, including BOXED WARNING, is available at www.gilead.com
Truvada, Truvada for PrEP, Descovy, Descovy for PrEP, COMPASS Initiative, Advancing Access, 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.
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
The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 04:00:00 EEST | Tiedote
For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta
Audi China President Thomas Owsianski to Keynote at CES Asia 201923.5.2019 23:00:00 EEST | Tiedote
The Consumer Technology Association (CTA)TM today announced that Thomas Owsianski, president of Audi China, will deliver a keynote address at the upcoming CES Asia 2019. Now in its fifth year, CES Asia will run June 11-13, 2019 at the Shanghai New International Expo Centre (SNIEC) in Shanghai, China. Thomas Owsianski’s keynote is scheduled for 4 PM, Tuesday, June 11, where he will unveil Audi’s vision in transforming mobility from a driving experience to a digital adventure. Mr. Owsianski joined the top management team of Audi China in August 2018 and was named President in October 2018. “Audi has been at the forefront of driving global transformation in the automotive industry through their breakthrough advancements in technology,” said Karen Chupka, executive vice president, CES. “Innovation has revolutionized the transportation experience, and we welcome Mr. Owsianski to the CES Asia stage to share Audi’s vision for the future of global mobility.” Throughout Asia and beyond, technol
ITechLaw Publishes New Book and Opens Global Public Comment Period on Draft Principles for Responsible Artificial Intelligence23.5.2019 22:11:00 EEST | Tiedote
The International Technology Law Association (ITechLaw) has published Responsible AI: A Global Policy Framework, a new book that provides an in-depth review and eight discussion principles that address some of the hottest technology and moral issues of responsible development, deployment and use of artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005752/en/ ITechLaw releases new book, Responsible AI: A Global Policy Framework, and opens public comment period. (Photo: Business Wire) Written by a multi-disciplinary group of 54 technology law experts, industry representatives and researchers from 16 countries, the book offers an actionable framework built on the following principles: Ethical Purpose and Societal Benefit, Accountability, Transparency and Explainability, Fairness and Non-discrimination, Safety and Reliability, Open Data and Fair Competition, Privacy, and AI and Intellectual Property.
Kumulus Vape, the 100% Online E-Cigarette Specialist, Goes Public23.5.2019 19:49:00 EEST | Tiedote
Kumulus Vape (ISIN FR0013419876 – MLVAP ), an online retailer specialised in the sale of electronic cigarettes and related products (devices, e-liquid and accessories), referred collectively as “e-cigarettes”, is pleased to announce the listing of its shares on the Euronext Access™ compartment in Paris by technical admission (Euronext notice PAR_20190523_05573_ACC). First listing will take place on 28 May 2019. This initial public offering - a first in Europe’s e-cigarette space - is a new milestone in the performance trajectory of the Lyon-based company, a pioneer on this market in acceleration phase. Kumulus Vape posted 2018 sales of €6.5 million, up 116% on 2017. Its outlook is highly auspicious, with 96% quarter-on-quarter growth in the first quarter of 2019. Kumulus Vape’s goal is clear: to become one of the French leaders in 100% online e-cigarette retail within three years. AN E-CIGARETTE PIONEER A CATALOGUE OF OVER 6,000 REFERENCES Kumulus Vape is one of the top online French r
Andersen Global Expands UK Locations23.5.2019 16:30:00 EEST | Tiedote
Claritas Tax Limited, a Birmingham, United Kingdom-based collaborating firm of Andersen Global, has opened a new office location in Deansgate, Manchester city center. This means that Andersen Global now has a presence in six locations in the UK through its member firms and collaborating firms. “Now more than ever, it’s important that businesses have easy access to quality advice in the UK’s dynamic political and business environment. The addition of another location in the region adds to our existing capabilities and will allow us to continue providing best-in-class service,” said Mark Vorsatz, Andersen Global Chairman and CEO of Andersen Tax LLC. Founded in 2012, Claritas Tax Limited has a list of clientele from entrepreneurial, privately owned, venture capital, and private equity owned businesses, listed companies and stakeholders. Claritas provides a broad range of tax consulting services, including all aspects of M&A and transactional taxes, R&D and Intellectual Property claims, sh
Mindbreeze Receives Attestation in Accordance with BSI Cloud Requirements23.5.2019 16:11:00 EEST | Tiedote
Mindbreeze receives attestation for its Mindbreeze InSpire SaaS service according to the specifications of the C5 catalogue of requirements (Cloud Computing Compliance Controls Catalogue, abbreviated C5), published by the German Federal Office for Information Security (BSI). The Mindbreeze InSpire SaaS service is professionally operated in Mindbreeze data centers on behalf of the customers. The attestation was issued by KPMG Alpen-Treuhand GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft. “The number of cloud services in the field of data analysis is growing steadily. This makes it all the more essential for customers to take a closer look at the choice of suppliers. C5 provides the regulatorily defined IT security level, which is comparable to the IT basic protection level that is increased by cloud controls,” explains Klaus Schatz, Managing Director of KPMG Advisory GmbH. C5 attestation (ISAE 3000 Report Type 2) is a recognized and authoritative verification for all customer
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