iconstar paper   HIV Articles  
Back grey arrow rt.gif
 
 
GILEAD SCIENCES AT THE 22ND INTERNATIONAL AIDS CONFERENCE (AIDS 2018)
- For Immediate Release
 
 
  CONTACTS:
Stephen Head, Media (EU)
+44 (0)7768 705945
Ryan McKeel, Media
+1 (650) 377-3548
 
- Partnering With Diverse Organizations to Highlight the Need for Greater Inclusivity in the Response to HIV Around the World
 
Foster City, Calif., July 19, 2018 -
Gilead Sciences, Inc. (NASDAQ: GILD) today announced its upcoming contributions to the 22nd International AIDS Conference (AIDS 2018), taking place in Amsterdam from July 23 - 27, 2018. In addition to presenting more than 40 abstracts on its HIV medicines, Gilead will reveal new research into public awareness and attitudes towards HIV across Western and Eastern Europe and support an array of partner events throughout the conference.
 
"We look forward to sharing new data and engaging with the community at AIDS 2018, as we collectively continue to break ground in addressing HIV globally - improving the health of people living with the virus, stopping the disease from spreading, and exploring new avenues of research toward identifying a cure," said Gregg Alton, Executive Vice President, International Operations and Corporate Affairs, Gilead Sciences. "Gilead's commitment to HIV goes beyond scientific innovation, and we firmly believe that, through partnerships, together we can end the epidemic."
 
Key Gilead events and partnership activities during the conference include:
 
o Is HIV Sorted?
(Monday 23 July, 12:00 - 13:00; Room G106/7, RAI) - Stigma is a key challenge impacting every stage of the UNAIDS 90-90-90 treatment target*. This challenge is driven, in part, by a lack of awareness and understanding of the current state of the HIV epidemic. This media-only event will reveal the results of a new pan-European survey commissioned by Gilead of more than 24,000 people in 12 countries, assessing the general public's perception of HIV.
 
* The goal that by 2020, 90 percent of people living with HIV will know their status, 90 percent of people diagnosed with HIV will receive sustained antiretroviral therapy and 90 percent of people receiving antiretroviral therapy will have viral suppression.
 
o Together, We Can Stop the Virus (Monday 23 July, 14:45 - 16:45; Elicium 2, RAI) - Significant progress has been made towards achieving the UNAIDS 90-90-90 treatment target, but challenges remain. This Gilead symposium, chaired by Anne Aslett from the Elton John AIDS Foundation and open to all delegates, will explore key successes and barriers to achieving 90-90-90 and the challenge beyond: how to reach and support the remaining 10-10-10 to ensure no one is forgotten in the fight against HIV.
 
------------------------
 
* The goal that by 2020, 90 percent of people living with HIV will know their status, 90 percent of people diagnosed with HIV will receive sustained antiretroviral therapy and 90 percent of people receiving antiretroviral therapy will have viral suppression.
 
-------------------------
 
o Positive Flame: 'Meet & Greet' (Wednesday 25 July, 16:35 - 16:40; Oosterdokskade, Amsterdam) - Graeme Robertson, Senior Director, Access Operations and Emerging Markets, Gilead Sciences, will host a meet and greet session along the route of the Positive Flame tour that will wind through the streets of Amsterdam. At this particular stop on the route, the torch will be handed from Nobel Laureate and discoverer of the HIV virus, Françoise Barré-Sinoussi, to a person who has been living with HIV for more than 34 years.
 
o Mastering the ART: Perspectives Evolved (Wednesday 25 July, 18:30 - 20:30; Elicium 2, RAI) - Professor Dr. Kees Brinkman from Onze Lieve Vrouwe Gasthuis, in the Netherlands, will chair a symposium sponsored by Gilead that reflects on the lessons from antiretroviral therapy, through stories told from personal experiences. Open to all, the symposium will address progress and challenges relating to people living with HIV remaining undetectable.
 
o Together, We Can (Thursday 26 July; 16:30 - 18:30; Calla 1, Hotel Novotel Amsterdam City) - A networking meeting hosted by Gilead for Asian HIV community groups, convening leaders from Singapore, Hong Kong and Taiwan to share perspectives on the HIV epidemic across their respective countries and exchange ideas around overcoming shared challenges.
 
o HIV in Eastern Europe & Central Asia: Breaking Barriers, Building Bridges (Thursday 26 July; 19:30 - 21:30; Rooms Calla 2 & 3, Novotel Hotel) - Eastern Europe and Central Asia (EECA) is the only region in the world in which HIV incidence is rising. People who inject drugs, men who have sex with men and sex workers and their clients are most affected. At this Gilead-sponsored event, leaders from these three communities will provide their perspectives on what barriers have driven the HIV epidemic in EECA and what bridges must be built at a local and regional level to overcome them.
 
Key abstracts on Gilead medicines to be presented at the conference include:
 
o The impact of pre-exposure prophylaxis with TDF/FTC on HIV diagnoses, 2012-2016, United States - [LBPEC036; Poster exhibit; Tuesday, July 24; 10:00 - 18:30; Hall 1]
 
o Pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) single-tablet regimen in HIV-1-infected children (6 to < 12 years) [WEAB0205; Oral presentation - ART in infants and children; Wednesday, July 25; 14:30 - 16:00; Hall 10]
 
o Patient-reported outcomes among HIV-1-infected adults randomized to B/F/TAF versus DTG/ABC/3TC in two Phase 3 controlled clinical trials over 48 weeks [TUPEB148; Poster exhibit; Tuesday, July 24; 10:00 - 18:30; Hall 1]
 
o B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment-naïve adults with high baseline viral load or low baseline CD4 count in 2 Phase 3 randomized, controlled clinical trials - [THPEB038; Poster exhibit; Thursday, July 26; 10:00 - 18:30; Hall 1]
 
o Renal safety of TAF vs. TDF or ABC in a pooled analysis of 27 Phase 2/3 clinical trials - [TUPEB113; Poster exhibit; Tuesday, July 24; 10:00 - 18:30; Hall 1]
 
o Changes in cardiovascular risk calculation and in fasting lipids in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing abacavir - [TUPEB103; Poster exhibit; Tuesday, July 24; 10:00 - 18:30; Hall 1]
 
o Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate - [TUPEB104; Poster exhibit; Tuesday, July 24; 10:00 - 18:30; Hall 1]
 
Follow Gilead on Twitter via @GileadSciences and keep up to date with the AIDS 2018 news and updates by using the hashtag #AIDS2018.
 
Please see below for Important U.S. Safety Information and Indications for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets; B/F/TAF) and Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablets; FTC/TDF) for PrEP (pre-exposure prophylaxis). Biktarvy is only approved for use in adults.
 
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY
 
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
 
o 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
 
o Coadministration:
Do not use BIKTARVY with dofetilide or rifampin.
 
Warnings and precautions
 
o 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.
 
o Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
 
o 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.
 
o 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
 
o Most common adverse reactions (incidence ≥5%; all grades) in clinical studies were diarrhea (6%), nausea (5%), and headache (5%).
 
Drug interactions
 
o Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
 
o 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.
 
o 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
 
o 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.
 
o Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
 
Dosage and administration
 
o Dosage: 1 tablet taken once daily with or without food.
 
o Renal impairment: Not recommended in patients with CrCl <30 mL/min.
 
o Hepatic impairment: Not recommended in patients with severe hepatic impairment.
 
o Prior to or when initiating: Test patients for HBV infection.
 
o 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 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 for ≥3 months with no history of treatment failure and no known resistance to any component of BIKTARVY.
 
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
 
o 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
 
o 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
 
Contraindications
 
o Do not use Truvada for PrEP in individuals with unknown or positive HIV status
 
Warnings and precautions: Comprehensive risk reduction strategies
 
o 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
 
o 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
 
o 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 the FDA for the diagnosis of acute HIV infection
 
o 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.
 
o 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
 
o 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
 
o 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
 
o 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
 
o Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of Truvada and monitor for adverse reactions
 
Adverse reactions
 
o Common adverse reactions (>2% and more frequently than placebo) of Truvada for PrEP in clinical trials were headache, abdominal pain, and weight loss
 
Drug interactions
 
o Prescribing information: Consult the full Prescribing Information for Truvada for more information, warnings, and potentially significant drug interactions, including clinical comments
 
o Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
 
o 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
 
o 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 US 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
 
o 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
 
o Dosage: One tablet once daily with or without food
 
o HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
 
o HBV screening: Test for HBV infection prior to or when initiating treatment
 
o 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
 
INDICATION
 
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
 
o 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 the FDA to aid in the diagnosis of acute HIV-1 infection
 
Individuals at risk for sexually acquired HIV-1 may include those:
 
o With HIV-1 infected partner(s), or
 
o 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
 
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 and cure research. Today, it's estimated that more than 11.5 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's generic manufacturing partners.
 
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 risk that physicians may not see the benefits of prescribing Truvada for PrEP or Biktarvy for the treatment of HIV and the possibility of unfavorable results from additional clinical trials involving Biktarvy. 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, 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 Biktarvy and Truvada, including BOXED WARNINGS, is available at www.gilead.com.
 
Biktarvy, 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

 
 
 
 
  iconpaperstack View Older Articles   Back to Top   www.natap.org