Petitions to US Patent and Trademark Office on HIV PrEP Patents

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Foster City, Calif. – August 21, 2019 – Gilead has submitted petitions to the U.S. Patent and Trademark Office requesting an inter partes review of patents granted to the U.S. Department of Health and Human Services (HHS) for HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). An inter partes review re-examines the claims in a patent to determine whether they are valid.

We strongly believe that the patents granted to HHS since 2015 for PrEP and PEP are not valid. Published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP in 2006, others had conceived of using an antiretroviral therapy, including Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets), for both forms of prophylaxis. For example, guidelines published in 2004 recommended administering combination antiretrovirals — including Truvada — to certain categories of “high risk” individuals before an HIV exposure, while the Center for Disease Control and Prevention’s (CDC) own 2005 guidelines recommended Truvada for prophylaxis immediately after exposure.

The ongoing dialogue about these patents is a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP. Resolving the patent issues will refocus the public dialogue about PrEP on what matters most: the real-world obstacles that prevent people at risk for HIV from accessing effective prevention. Those with the greatest need for PrEP face significant social and structural barriers, such as limited access to affordable healthcare, low awareness of PrEP, stigma, discrimination, and insurance benefit design that places a significant cost-sharing burden on patients.

Gilead remains committed to increasing access to PrEP for everyone in need and we will continue to invest in a wide range of programs to help accelerate access and awareness. We work closely with advocates, providers and others to support PrEP education, outreach and access in the communities most affected by HIV. Where cost is a barrier, we work to address it. Today, a person with Medicare typically pays between $0 and $5 per month for Truvada for PrEP®; a person with Medicaid typically pays between $4 and $9 per month; and a person with insurance through an employer or private party typically pays between $0 and $35 per month.

Please see below for Indication and Important Safety Information for Truvada for PrEP, including Boxed Warning.

As it has for decades, Gilead will continue to work collaboratively with federal agencies, including HHS and CDC, on efforts to end the HIV epidemic in the United States. This includes Gilead’s donation to CDC of up to 2.4 million bottles of HIV prevention medication annually for uninsured Americans at risk for HIV through 2030.

U.S. Indication for Truvada for PrEP

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

U.S. Important Safety Information 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.

Contraindications

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="">
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.

Drug interactions

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.

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.

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="" a="" clinically="" appropriate="" schedule.="" in="" patients="" with="" chronic="" kidney="" disease,="" also="" assess="" serum="">

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 possibility that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office (PTAB) may deny institution of Gilead’s petitions for inter partes review of patents granted to HHS for HIV PrEP and PEP. Further, even if the PTAB institutes Gilead’s petitions for inter parties review, the PTAB may not rule in Gilead’s favor. 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 June 30, 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 Truvada, including BOXED WARNING, is available at www.gilead.com.

GILEAD, TRUVADA, and TRUVADA FOR PrEP are trademarks of Gilead Sciences Inc., or its related companies.