Gilead Presents New Data from Antiviral Development Programs at IDWeek 2020

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of 18 abstracts spanning the company’s HIV treatment and prevention and COVID-19 clinical development programs during the virtual IDWeek 2020 conference from October 21-25. The breadth of data reflects Gilead’s commitment to advancing antiviral innovation aiming to help end the HIV epidemic and to addressing the treatment needs of patients with COVID-19.

“The global HIV epidemic and the COVID-19 pandemic are two of the most complex public health challenges of our time,” explained Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “The data presented at IDWeek reflect the latest progress in Gilead’s antiviral drug discovery and development and underscore our commitment to supporting the global health community to quickly and effectively respond to devastating viral outbreaks worldwide.”

At IDWeek 2020, Gilead will present results from the ongoing DISCOVER multi-center randomized clinical trial, evaluating the safety and efficacy of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP^® and a new analysis leveraging a novel statistical method to estimate the background HIV incidence rate in DISCOVER. Separate data from DISCOVER will provide insight into the impact of age and comorbidities on renal outcomes for study participants. In addition to new data from the DISCOVER trial, the key findings from an analysis examining real-world patterns of persistence with Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for PrEP^® in at-risk populations will be presented in an oral presentation.

Gilead also will present new data on the efficacy and safety of Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in certain populations of people living with HIV that have historically been underrepresented in HIV clinical research. The latest data from Gilead’s HIV treatment research program to be presented include an oral presentation on 48-week outcomes from the landmark community-based and designed BRAAVE study evaluating the safety and efficacy of switching to Biktarvy among Black American adults living with HIV who are virally suppressed. Findings on the efficacy of Biktarvy in people living with HIV who are virologically suppressed with end-stage renal disease and requiring chronic hemodialysis will also be presented.

Data on Gilead’s investigational antiviral Veklury^® (remdesivir) for injection (100 mg) administered by intravenous infusion for the treatment of COVID-19 include two oral presentations examining the safety and efficacy of Veklury in hospitalized patients with moderate COVID-19 and global geographical disparities in clinical outcomes of hospitalized patients with severe COVID-19 treated with Veklury in Gilead’s open-label, Phase 3 SIMPLE studies.

Select accepted abstracts are as follows:

HIV prevention research

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• Oral 103: Persistence on Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for HIV Pre-Exposure Prophylaxis: Insights From Real-World Evidence
• Poster 999: Using the Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Adherence-Efficacy Relationship to Calculate Background HIV Incidence: Results From the DISCOVER trial
• Poster 985: Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial
• Poster 995: Safety and Efficacy of Emtricitabine/Tenofovir Alafenamide (F/TAF) and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for PrEP in DISCOVER Participants Taking F/TDF for PrEP at Baseline

HIV treatment research

• Oral 109: Pre-Existing Resistance and Week 48 Virologic Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in African American Adults With HIV
• Late Breaker 7: Weight Change in Suppressed People With HIV (PWH) Switched From Either Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) to Tenofovir Alafenamide (TAF)
• Poster 1046: Week 48 Outcomes From the BRAAVE 2020 Study: A Randomized Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in African American Adults With HIV
• Poster 1002: A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed Adults Living With HIV and End Stage Renal Disease on Chronic Hemodialysis
• Poster 1028: Long-term Follow-up After a Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir/Abacavir/Lamivudine
• Poster 1448: Forgiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF): In Vitro Simulations of Intermittent Poor Adherence Find Limited HIV-1 Breakthrough and High Barrier to Resistance
• Poster 633: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants With Pre-Existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials

COVID-19 treatment research

• Oral 72: Remdesivir vs. Standard Care in Patients With Moderate COVID -19
• Oral 73: Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated With Remdesivir
• Poster 561: Safety of Remdesivir vs. Standard Care in Patients With Moderate COVID-19
• Poster 557: Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients

For more information, including a complete list of abstracts, please visit: https://www.eventscribe.com/2020/IDWeek/index.asp

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

There is no cure for HIV or AIDS.

Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use, and its safety and efficacy have not been established. Gilead submitted a new drug application for Veklury on August 7, 2020; the NDA is currently under FDA review. Veklury is currently authorized for temporary use under an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19, including patients with moderate to severe disease, regardless of the need for supplemental oxygen. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

U.S. Important Safety Information and Indication 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: 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, 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 <30 mL/min.
• 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 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 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.

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.

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 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 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 virus (HBV) have been reported in patients who have HBV infection and 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

Contraindication:

• TRUVADA FOR PrEP is contraindicated in patients with unknown or positive HIV status

Warnings and precautions:

• Comprehensive management to reduce risks:
  • Use TRUVADA 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 status, including viremic status, regular testing for STIs)
  • Reduce potential for drug resistance: Only prescribe TRUVADA FOR PrEP to patients 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 patients with undetected HIV-1 infection who are taking only TRUVADA because TRUVADA alone is not a complete regimen for treating HIV-1
  • Some HIV tests may not detect acute HIV infection. Prior to initiating TRUVADA 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 TRUVADA FOR PrEP, convert the TRUVADA 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 impairment and Fanconi syndrome have been reported with the use of TDF. TRUVADA is not recommended in patients 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

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

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

Pregnancy and lactation:

• Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no significant difference 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 ri

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