GILEAD LAUNCHES NATIONAL TELEVISION ADVERTISING CAMPAIGN TO INCREASE PUBLIC AWARENESS OF TRUVADA FOR PrEP® (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) AS AN HIV PREVENTION OPTION
– Ad Launches June 25 and Aims to Reach Individuals & Communities at Risk for HIV –
Foster City, Calif., June 25, 2018 – Gilead Sciences, Inc. today announced the launch of a national advertising campaign to heighten public awareness of Truvada for PrEP® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) as an HIV prevention option. The campaign, I’m on the Pill, is intended to educate individuals about the once-daily therapy, that when taken every day and used together with safer sex practices, can help prevent HIV. The ad will begin airing today across multiple media platforms, including broadcast TV.
Truvada for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. To take Truvada for PrEP, individuals must be confirmed to be HIV-negative and be tested for HIV immediately prior to initiating and at least every 3 months while taking Truvada for PrEP. Truvada has a boxed warning in its product label regarding the risks of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection and post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and prescribing considerations are included below.
According to the U.S. Centers for Disease Control and Prevention, nearly 40,000 people in the United States are diagnosed with HIV infections every year and 1.1 million individuals are estimated to be at elevated risk for sexually acquired HIV.
The campaign features a diverse group of individuals, representative of the communities disproportionately affected by HIV, including, Black, Latino and white gay, bisexual and other men who have sex with men; Black cisgender women who have sex with men; and transgender women who have sex with men, notably transgender women of color.
A multimedia gallery, including video and photos are available at: GileadHIVMedia.com
“At Gilead, we are committed to supporting the public health response to the HIV epidemic. HIV infection rates in the United States continue to be a significant concern, particularly among marginalized communities. The goal of this new awareness campaign is to encourage more people to talk with a healthcare provider about their HIV risk and Truvada for PrEP as a potential HIV prevention option,” said Douglas M. Brooks, Senior Director for Community Engagement at Gilead. “By pairing education with scientific advances in HIV prevention, we hope to help people empower themselves with information and tools to have an informed discussion with their healthcare provider about their individual health.”
“As an advocate in the HIV/AIDS community for over 30 years, I’ve seen so many lives changed instantly by an HIV diagnosis, including my own,” said Jesse Milan, Jr. JD, President and CEO, AIDS United. “Many people who are most vulnerable to HIV infection still don’t know that Truvada for PrEP is a prevention tool that can be combined with safer sex practices to help prevent new HIV infections. Gilead’s commitment to engaging communities disproportionately affected by HIV will increase public awareness about PrEP and help advance public understanding about the continuing risks facing far too many individuals and communities.”
“I’ve spent years combating stigma and inequities, as well as securing resources for people living with HIV, especially for my Transgender sisters and brothers. Despite great advances in prevention and treatment, HIV is still very much a reality in our country, disproportionately impacting communities of color, men who have sex with men, and transgender people, who are also the most marginalized group in the epidemic,” said Tori Cooper, Prevention Specialist, Positive Impact Health Centers, Atlanta GA. “That's why it's important to foster wider awareness of prevention strategies, including Truvada for PrEP, for people at risk of HIV, through partnerships among health departments, community-based organizations, and health care and social service providers. I’m hopeful that this campaign, coupled with the incredible work that’s being done by the HIV advocacy community, will encourage more people to think about and discuss HIV prevention and sexual health.”
I’m on the Pill will appear on broadcast TV and on-demand channels with supporting campaign materials featured on digital platforms and appearing in print media.
Truvada for PrEP does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR TRUVADA for PrEP IN U.S.
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
- TRUVADA for PrEP is contraindicated 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 the 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 section
- 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 US reference population. Consider HIV prevention methods, including TRUVADA for PrEP in 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 the 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
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 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
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. 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, including BOXED WARNING, for Truvada is available at www.gilead.com.
Truvada, Truvada for PrEP, 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.