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.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Age, Gender, Disease Severity Impact Adherence to Long-Term PAP Therapy More Than Previously Thought19.5.2019 19:15:00 CEST | Pressemelding
ResMed (NYSE: RMD, ASX: RMD) today revealed several demographic and clinical factors affect adherence to PAP (positive airway pressure) therapy, according to a study it presented at the American Thoracic Society's ATS 2019 International Conference. The study found significant differences in one-year adherence between people of different ages and disease severity levels: Men with sleep apnea are 8.5 percentage points more likely to stay adherent on PAP therapy than women. People over age 60 were 7.3 percentage points more adherent than the entire study cohort (77.7% vs. 70.4%). People with self-reported severe sleep apnea were 78% adherent at the one-year mark, compared to 70.5% of those with self-reported moderate sleep apnea, and 65.2% of those with mild sleep apnea. “Sleep specialists, pulmonologists, and primary care physicians should heed these results and ensure that their younger, female, and more mildly diagnosed patients have the proper supports to stay on therapy,” said Adam B
Workiva Named Best-In-Class Cloud Service Provider at UK Cloud Awards17.5.2019 12:00:00 CEST | Pressemelding
Workiva (NYSE:WK), the leading cloud provider of connected data, reporting and compliance solutions, was named the Best-In-Class Cloud Service Provider by the UK Cloud Awards 2019 at a ceremony here last night. Now in its sixth year, the UK Cloud Awards recognise innovation and excellence in the cloud industry by showcasing leading companies, customers and individuals in the United Kingdom. Workiva was recognised for its Wdesk platform that helps organisations consolidate, connect and tag their data in a single, cloud environment so they are able to reduce risk and save time when filing reports with various regulators and other stakeholders. Workiva, the global leader in XBRL and Inline XBRL, is also streamlining how customers comply with the European Securities and Markets Authority's mandate for Inline XBRL for European Single Electronic Format (ESEF) reporting. More than 5,000 EU issuers will be required to use ESEF taxonomy for their annual financial reports, ending on or after Jan
Novaremed Presents Top-Line Results from Phase 2a Diabetic Neuropathic Pain Study of NRD.E1 at NeuPSIG 201917.5.2019 10:13:00 CEST | Pressemelding
Novaremed AG, a clinical-stage Swiss biopharmaceutical company, today announced a poster presentation highlighting the top-line results from a Phase 2a (Proof of Concept) study of NRD.E1 for the treatment of diabetic neuropathic pain (DNP). The poster presentation took place at the 7th International Congress on Neuropathic Pain Meeting (NeuPSIG) in London, UK on May 9-11, 2019. “This was our first communication at a leading neuropathic pain-focused event. Novaremed’s lead drug, NRD.E1 is a non-opioid small molecule for the treatment of neuropathic pain. The results of our Phase 2a in patients with DNP showed clinically relevant treatment benefit from NRD.E1 across multiple primary and secondary endpoints, providing a strong scientific foundation for advancing the development of NRD.E1 into the upcoming global Phase 2b study in DNP,” said Sara Mangialaio, Head of R&D and Chief Medical Officer of Novaremed AG. “NRD.E1 has the potential to address a major unmet medical need in DNP.” Poste
WIN 2019 Symposium: WINnovation and Global Deployment of Precision Oncology17.5.2019 09:38:00 CEST | Pressemelding
The 11th WIN Symposium in Precision Oncology will be held in Paris, France on June 23-24, 2019. ASCO® endorsed for the past 11 years, the WIN symposium will deliver an exciting line-up of speakers in Paris (France) on June 23-24, 2019 to discuss Innovation and Global Deployment of Precision Oncology. The current status of Precision Oncology across the globe will be examined with the exceptional participation of the chairmen of the event, Richard L. Schilsky, Chairman WIN Consortium(*), Senior Vice-President and Chief Medical Officer of ASCO, and Josep Tabernero, Vice Chairman WIN Consortium, President of ESMO and Director of Vall d’Hebron Institute of Oncology, Spain. Global experience will be shared: Optimizing Patient Enrollment and Efficacy of Precision Oncology Clinical Trials at UT MD Anderson Cancer Center, USA Decision Support for Precision Oncology: Evolving from Monotherapy to Genomically Informed Combinations, UT MD Anderson Cancer Center, USA The Value of Personalized Medici
Corsearch Acquires Principium Trademark Watch and Domain Services Businesses17.5.2019 08:00:00 CEST | Pressemelding
Corsearch, the global brand creation, clearance, and protection leader, is pleased to announce the acquisition of the Principium Strategies trademark watch and domain services businesses, the brand protection subsidiary of Ladas and Parry LLP, a leader in global intellectual property law. The acquisition is effective immediately, solidifying and expanding Corsearch’s full-service trademark solutions offering for clients and brands globally. Principium is Corsearch’s third acquisition since becoming a standalone company in January 2018. The acquisition brings Corsearch’s employee count to more than 350 operating in 28 locations worldwide and adds valuable industry expertise and additional capabilities to Corsearch. “This is another really exciting acquisition for our business and a step forward in the evolution of Corsearch,” said Stephen Stolfi, Chief Commercial Officer of Corsearch. “Principium has provided clients with industry-leading trademark watching services for over 80 years an
CNT Among SAP’s "Best of the Best"17.5.2019 08:00:00 CEST | Pressemelding
Since 2005, SAP is honoring the best of the best SAP projects yearly in Europe, Middle East and Africa. In 2018, 280 customers from 15 markets submitted their regional Gold Award-winning projects. CNT Management Consulting from Vienna won Bronze twice – together with its customers HOERBIGER and TANNPAPIER – a happy day for CNT’s CEO Andreas Doerner. "We are now on the podium for the second time with two projects – thanks to the trust of our customers." The SAP Quality Awards EMEA were presented at an exceptionally festive ceremony in Heidelberg Castle (Baden-Wuerttemberg), and only twelve SAP customers were able to take home the most wanted trophies that were presented by SAP Presidents Brian Duffy (EMEA North) and Hartmut Thomsen (Middle and Eastern Europe). The jury evaluated the projects according to the ten SAP quality principles and the question of whether the respective project could fulfill the expectations of its clients. HOERBIGER - Category Business Transformation Headquarter