FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).
- One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19.
- In a separate study, Veklury use was associated with significantly reduced mortality among people who were immunocompromised and were hospitalized for COVID-19 during the Omicron period (Dec’21 – April’23), irrespective of oxygen requirements.
- A third analysis revealed that treatment with Veklury and dexamethasone among patients hospitalized for COVID-19 was associated with reduced mortality as compared to treatment with only dexamethasone, irrespective of oxygen requirements.
“The real-world data presented at CROI continue to reinforce the strong efficacy and safety profile of Veklury, as well as the potential benefit of Veklury for people affected by COVID-19,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “As we enter the fourth year of COVID-19, Veklury remains the antiviral standard of care for people hospitalized for COVID-19. These latest data add to our scientific understanding about Veklury’s potential role in reducing mortality, including in immunocompromised people, and helping to reduce the risk of getting long-COVID symptoms.”
To understand Veklury’s potential impact on the risk of long-COVID, also known as post-COVID conditions (PCC), Gilead analyzed HealthVerity data from 52,006 patients. Results from the study demonstrate that Veklury use was associated with a 10% lower risk of any PCC in both age groups analyzed: HR 0.90 (95% confidence interval [CI]: 0.86–0.93) in those <65 years old and HR 0.90 (95% CI: 0.86–0.95) in those ≥65 years old. Veklury use was associated with lower risk for 6 of 16 individual symptoms/diagnoses in the ≥65 age group (including cognitive dysfunction, cerebrovascular disease, neuropsychiatric features, diarrhea, chest pain, and dysautonomia) and for 8 of 16 individual symptoms/diagnoses in the <65 age group (including the 6 symptoms in the ≥65 age group, as well as thromboembolic disease and headache). Results from this analysis build on existing evidence that support the importance of treating COVID-19 early in the disease course with an antiviral.
In a separate analysis, data from the PINC AI Healthcare database from the Omicron era (Dec’21 – Apr’23) showed an association between Veklury use and reduced mortality among immunocompromised people in the study who were hospitalized for COVID-19. The study included 10,687 immunocompromised people who received Veklury and 4,989 who were matched controls. Results at Day 28 showed that people who were immunocompromised and treated with Veklury had an overall 25% significantly lower mortality risk compared to the non-Veklury group, irrespective of supplemental oxygen requirements (HR: 0.75, 95% CI:0.68-0.83; p<0.0001). This research builds on and further reinforces previous research presented at CROI 2023.
Additional data from a real-world study showed improved outcomes among patients with COVID-19 who received treatment with Veklury in combination with dexamethasone compared to dexamethasone alone. The study matched 33,037 patients who received both Veklury and dexamethasone to 33,037 patients who received only dexamethasone. Patients who received the dual therapy had a significantly lower mortality risk compared to dexamethasone monotherapy across all supplemental oxygen requirements at both 14 and 28 days. For patients with no documented use of supplemental oxygen at baseline, treatment with Veklury was associated with a 20% (p<0.001) lower risk of mortality at Day 28. Patients on low-flow or high-flow oxygen had a 26% (p<0.001) and 29% (p<0.001) lower risk of mortality at Day 28, respectively. Patients on invasive mechanical ventilation/ECMO at baseline had a 19% (p=0.0182) reduced risk for mortality at Day 28.
About Veklury
Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and limited known drug interactions in diverse populations. It plays an important role in reducing disease progression across a spectrum of disease severity and enabling patients to recover faster.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 14 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program.
U.S. Indication for Veklury
Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (weighing ≥1.5 kg) who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. Important Safety Information for Veklury
Contraindication
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury.
Adverse reactions
- The most common adverse reaction (≥5% all grades) was nausea.
- The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.
Drug interactions
- Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.
Dosage and administration
- Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
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Treatment duration:
- For patients who are hospitalized, Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
- For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
- Testing prior to and during treatment: Perform hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate.
- Renal impairment: No dose adjustment of Veklury is recommended in patients with any degree of renal impairment, including patients on dialysis. Veklury may be administered without regard to the timing of dialysis.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established for Veklury. Available clinical trial data for Veklury in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of Veklury exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy.
- Lactation: Veklury can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veklury and any potential adverse effects on the breastfed child from Veklury or from an underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
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, COVID-19, and cancer. 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 within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; uncertainties relating to regulatory applications and related filing and approval timelines; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2023, 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 involve risks and uncertainties 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 Veklury is available at www.gilead.com.
Veklury, 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.
