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AHF Dumbfounded by Gilead’s Claim of No AIDS Stigma Today

In recent legal filing in lawsuits over one of its HIV/AIDS medications that causes permanent and potentially deadly damage to the kidneys and bones, Gilead’s white shoe law firm, Sidley Austin, stumbles as it claims “…there is no shame or stigma …” associated with the disease today

At the same time its lawyers deny AIDS stigma, NBC News reported that Gilead itself funded a newly released study that found half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.”

LOS ANGELES–(BUSINESS WIRE)–Today, AIDS Healthcare Foundation announced that in a recent legal filing in personal injury lawsuits against Gilead Sciences Inc. seeking to hold the Bay Area drug maker accountable over one of its HIV/AIDS medications that allegedly causes permanent damage to the kidneys and bones, lawyers for Gilead claimed that “no shame or stigma” remains associated with HIV/AIDS today as they sought to reverse a judicial order denying Gilead access to AHF’s patient and client mailing lists.

In an August 9, 2021 filing in the Superior Court of California County of San Francisco (Case No. CJC-19-005043) seeking reconsideration of the Court’s Recommended Order No. 19 (Motions to Quash, and to Modify, Deposition Subpoena For Production of Business Records to AIDS Healthcare Foundation), lawyers for Sidley Austin, Gilead’s law firm, twice asserted there is no longer stigma associated with HIV or AIDS today, writing:

  • “Support for the HIV/AIDS community is not even stigmatized in today’s society,” (pleading, P #5, lines 19 & 20), and
  • “Further, there is no shame or stigma associated with supporting those affected by HIV/AIDS…” (pleading, P #9, lines 17 & 18).

At nearly the same time Gilead’s lawyers dubiously claimed that no HIV/AIDS stigma remains today, a new study undertaken by the LGBTQ advocacy group GLAAD and the Southern AIDS Coalition found that half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.” According to NBC News, the study, “The State of HIV Stigma 2021”, was published and widely reported on August 26, 2021.

NBC News also reported that Gilead funded the study.

Gilead’s assertions denying the existence of stigma surrounding HIV/AIDS today came about in its response to multiple personal injury lawsuits by patients taking Gilead medications. The lawsuits focus on Gilead’s failure to rectify a known defect in its tenofovir disoproxil fumarate (TDF) drug formulation, knowing that a safer alternate, tenofovir alafenamide (TAF) existed—in Gilead’s own laboratories—and for its failure to warn patients of the damaging side effects of TDF as well as Gilead’s active misrepresentation of TDF’s efficacy and risks. AHF supported many of the plaintiffs’ lawsuits, which likely led to Gilead’s discovery requests for its mailing lists.

Gilead’s zeal to maintain and maximize its corporate profits came at the expense of the health and wellbeing of its customers who were prescribed and taking TDF. According to earlier pleadings in the cases, the company knew as far back as 2001 from its own studies and other research that TDF was, ‘…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.’

“It’s official, according to Gilead: there is no longer any stigma around AIDS today,” said Michael Weinstein, president of AHF. “I suppose that means Gilead wasted a lot of money on its recent—and disheartening—GLAAD/Southern AIDS Coalition study documenting the ongoing and severe stigma around HIV and AIDS. Perhaps Gilead should instead spend its energy developing a drug to treat the willful blindness associated with its overwhelming greed. They make billions of dollars harming HIV/AIDS patients when they knew they had a better, less toxic drug sitting on the shelf. Now, they declare AIDS stigma no longer exists. Gilead, what astounding arrogance—and greed!”

About AHF

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare

Contacts

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 mobile

[email protected]

Gilead counterfeit versions HIV meds found in US OutBuro LGBTQ professional entrepreneur online networking community lesbian bisexual transgender nonbinary

Gilead warns that counterfeit versions of its HIV meds are being found in US

U.S. pharmacies are selling counterfeit versions of HIV medication, according to the biopharmaceutical company Gilead Sciences. Specifically, Gilead warned that knock-off versions of its Biktarvy and Descovy medications have circulated through pharmacies due to unauthorized distributors. Both medications are used to treat people living with HIV. Descovy is also used as pre-exposure prophylaxis (PrEP) to prevent HIV-negative people from contracting the virus. The company is working with the U.S. Food and Drug Administration, pharmacies and other legal authorities to track down the culprits and remove the counterfeit meds from the market. Gilead said the counterfeit and tampered medicines can “bring serious and sometimes life-threatening health risks to individuals.”

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Gilead to Present New Data at IAS 2021 Demonstrating the Company’s Commitment to Advancing Innovation in HIV Research

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming contributions to the 11th International AIDS Society (IAS) Conference on HIV Science, taking place virtually from July 18-21. Thirty-one abstracts reflect Gilead’s ongoing commitment to scientific innovation, a key pillar to addressing unmet needs in HIV treatment and prevention. Beyond presenting new scientific data from the company’s HIV research and development programs, Gilead will convene a symposium featuring a diverse, global panel of leading HIV researchers and people living with HIV, to discuss potential clinical pathways to achieve a functional cure and community perspectives on the process.

Continued scientific innovation is essential to helping end the global HIV epidemic and we are committed to advancing the next generation of therapies to improve the care of people and communities impacted by this disease,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Our data at this year’s meeting demonstrate the important scientific advancements we are making to help address critical unmet needs for people with HIV and those who could benefit from PrEP medicines.”

Presentations from Gilead’s HIV research program will include:

  • A pooled analysis of 192-week data from open-label extension periods of two Phase 3 trials evaluating the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve adults living with HIV
  • 72-week data from the BRAAVE trial evaluating the safety and efficacy of switching to Biktarvy in Black or African American adults who are virologically supressed
  • Data from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting subcutaneously administered HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people living with multidrug resistant HIV
  • Interim Phase 2 data from the open-label CALIBRATE trial evaluating the safety and efficacy of lenacapavir as an investigational, long-acting HIV capsid inhibitor in combination with other antiretroviral agents in treatment-naïve people living with HIV
  • Data from a Phase 1b trial examining the impact from the investigational TLR7 agonist, vesatolimod, between certain immune responses in people living with HIV on antiretroviral therapy
  • Prevention research, including data exploring adherence to PrEP medicines among new PrEP users initiating Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP®, real-world utilization of PrEP medicines during the COVID-19 pandemic and the safety and efficacy profile of Descovy for PrEP, as well as the use of novel study designs for HIV prevention trials

Select accepted abstracts are as follows:

HIV Treatment Research

Week 72 Outcomes and COVID-19 Impact From the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults Living With HIV

Long-Term Efficacy Among Participants Switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) With Pre-Existing Resistance and Viral Blips

Long-Term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-Up

Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials

Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged 65 Years or Older: Week 96 Results From an International, Phase 3b, Open-Label Trial

Investigational Long-Acting HIV Treatment Research (Lenacapavir)

Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as Part of a Combination Regimen in Treatment-Naïve People With HIV: Interim 16-Week Results of a Randomized, Open-Label, Phase 2 Induction-Maintenance Study (CALIBRATE)

Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With HIV: Week 26 Results (CAPELLA)

HIV Cure Research

Proteomic Evidence of Vesatolimod-Induced Enhancement of “Cross-talk” Between Innate and Adaptive Immune Cells in HIV Controllers on ART

HIV Prevention Research

Outcomes of Participants Switching from F/TDF to F/TAF for PrEP: Week 48 Results From the DISCOVER Open Label Phase

Comparing Adherence to HIV Pre-Exposure Prophylaxis (PrEP) Among New, Male PrEP Users Initiating F/TAF vs. F/TDF

Real-World Utilization of F/TDF and F/TAF for HIV Pre-Exposure Prophylaxis During the COVID-19 Pandemic in the U.S., December 2019 – June 2020

HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEP Trials

For more information, including a complete list of abstracts, please visit: https://www.ias2021.org/the-programme.

Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy® and Descovy for PrEP®.

Lenacapavir and vesatolimod are investigational compounds and are not approved by the U.S. Food & Drug Administration or any regulatory authority for any use. Their safety and efficacy have not been established. In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

There is currently no cure for HIV or AIDS.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg 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 with no history of treatment failure and no known resistance to any component of Biktarvy.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • 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

  • Coadministration: Do not use Biktarvy with dofetilide or rifampin.

Warnings and precautions

  • 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.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate Biktarvy in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. 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, assess 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 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

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • 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.
  • 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.

Dosage and administration

  • Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • 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.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of Biktarvy during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using Biktarvy during pregnancy and conception. 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.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

U.S. Indication for Descovy for PrEP

Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use:

  • Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

U.S. Important Safety Information and Indication for Descovy for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Descovy for PrEP must be prescribed only to patients 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 emtricitabine/tenofovir disoproxil fumarate
  • (FTC/TDF) for HIV-1 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 patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of Descovy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue Descovy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindication:

  • Descovy for PrEP is contraindicated in patients with unknown or positive HIV status.

Comprehensive management to reduce risks:

  • Use Descovy for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
  • HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
  • Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs).
  • Reduce potential for drug resistance: Only prescribe Descovy for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Descovy, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Descovy because Descovy alone is not a complete regimen for treating HIV-1.

    • Some HIV tests may not detect acute HIV infection. Prior to initiating Descovy for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
    • If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Descovy for PrEP, convert the Descovy for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
  • Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.

Warnings and precautions:

  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. 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. Monitor renal function in all patients (see Dosage and Administration section).
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. 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.

Adverse reactions:

  • Most common adverse reactions (≥2%) in the Descovy for PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain.

Drug interactions:

  • Prescribing information: Consult the full Prescribing Information for Descovy for more information, warnings, and potentially significant drug interactions, including clinical comments.
  • Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of Descovy. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy.
  • Drugs affecting renal function: Coadministration of Descovy 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.

Dosage and administration:

  • Dosage: One tablet taken once daily with or without food.
  • HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section).
  • HBV screening: Test for HBV infection prior to or when initiating Descovy.
  • Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; the possibility of unfavorable results from such ongoing and additional clinical trials; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and vesatolimod and as a result, these compounds may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including marketing approvals of lenacapavir and vesatolimod, and the risk that any such approvals, if granted, may have significant limitations on its use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. full Prescribing Information for Biktarvy and Descovy for PrEP, including BOXED WARNINGS, are available at www.gilead.com.

Biktarvy, Descovy for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Jacquie Ross, Investors

+1 (650) 358-1054

Brian Plummer, Media

+1 (202) 309-5207

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

If Approved, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Every 6 Months

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. Key data on lenacapavir will be presented during the 11th International AIDS Society (IAS) Conference on HIV Science in July 2021.

In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir, which is being studied as an every-six-month subcutaneous injection, is a potential first-in-class capsid inhibitor for the treatment of HIV-1 infection without overlapping resistance with any currently approved antiretroviral therapy (ART).

Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV.”

Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with MDR HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is designed to inhibit HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation.

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3 double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir administered every 6 months as a subcutaneous injection in HTE people with MDR HIV-1 infection. CAPELLA includes men and women living with HIV-1 and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. The primary endpoint was the proportion of participants randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥ 0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

The study achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). Those who received lenacapavir (n=24) achieved statistically significantly greater mean decrease in viral load than those who received placebo (n=12) during the functional monotherapy period (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL, p<0.0001). Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events. The most common adverse events observed were injection site reactions.

Following the 14-day functional monotherapy period, participants who were randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The trial data for the first six-month period (Week 26) have been submitted to the FDA as part of the NDA filing, and will be presented at an upcoming conference.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068.

About Lenacapavir

Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir’s multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes.

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from a completed Phase 1 study support further evaluation of lenacapavir administered subcutaneously every six-month for both HIV-1 treatment and prevention. During IDWeek 2020, the company announced plans to evaluate the use of lenacapavir as an injectable PrEP option administered every six months among cisgender women, men who have sex with men and persons of trans experience. The prevention trials have projected initiation dates in 2021.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving lenacapavir; the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving lenacapavir; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA, European Medicines Agency or other regulatory approval of lenacapavir, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and that, as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Jacquie Ross, Investors

(650) 358-1054

Brian Plummer, Media

(202) 309-5207