New Real-World Data Further Support the Use of Veklury® (Remdesivir) for People Hospitalized With COVID-19
- Veklury associated with lower risk of developing long-COVID in one analysis.
- Veklury linked to reduced mortality among immunocompromised COVID-19 patients in a separate analysis.
- Real-world data supports Veklury's efficacy and safety profile for COVID-19 patients.
- Veklury remains the antiviral standard of care for hospitalized COVID-19 patients.
- None.
Insights
The recent findings presented regarding Veklury, known generically as remdesivir, are significant in the context of ongoing COVID-19 management, particularly for those with compromised immune systems. The data indicating a lower risk of long-COVID symptoms and reduced mortality rates provide a compelling argument for the continued use of this antiviral in hospital settings. The association between Veklury and improved outcomes in immunocompromised patients is particularly noteworthy, as this subgroup faces a higher risk of severe disease progression and complications.
It is essential to understand that 'association' does not necessarily imply causation and retrospective studies have inherent limitations, including potential biases and confounding factors. However, these studies can still provide valuable real-world evidence that complements randomized controlled trials. The observed benefits in conjunction with dexamethasone, a corticosteroid, suggest a possible synergistic effect, which could inform treatment protocols and guidelines.
The clinical implications extend beyond immediate survival rates, touching on the quality of life post-recovery. The potential reduction in long-COVID symptoms could alleviate the long-term burden on healthcare systems and improve patient outcomes. However, continuous monitoring and further research are needed to validate these findings and optimize treatment regimens.
The economic implications of these findings are substantial. If Veklury indeed reduces long-COVID symptoms and mortality among the immunocompromised, it could lead to lower healthcare costs associated with prolonged hospital stays, post-acute care and long-term disability. The reduction in mortality rates could also have indirect economic benefits by maintaining the productivity of the workforce.
However, the cost-effectiveness of Veklury must be carefully evaluated. The drug's price, the healthcare system's capacity to administer it effectively and the potential need for additional supportive care are all factors that impact its overall economic value. Policymakers and healthcare providers must weigh the benefits against the costs to make informed decisions about resource allocation, especially in a pandemic setting where efficient use of resources is paramount.
Moreover, the broad application of these findings across different healthcare systems globally would require an assessment of varying healthcare infrastructures, access to medication and economic disparities. This analysis could guide international health policy and funding decisions, especially in resource-limited settings.
The announcement of these studies could have implications for Gilead Sciences' market position. As the manufacturer of Veklury, Gilead could see an increased demand for the drug, particularly as the data suggests utility beyond the immediate treatment of COVID-19 to include long-term symptom management and benefits for high-risk patient populations.
The pharmaceutical market is highly responsive to clinical data and positive results can lead to increased stock valuations. Investors and stakeholders will be closely monitoring the uptake of Veklury in the healthcare system and any potential expansion of its approved indications. The competitive landscape of COVID-19 treatments is continually evolving and Gilead's ability to demonstrate sustained efficacy and safety of Veklury will be crucial in maintaining its market share against emerging therapies.
It's also worth noting that the long-term demand for COVID-19 treatments will depend on the trajectory of the pandemic, vaccination rates and the emergence of new variants. Gilead's strategic planning and continued investment in research will be key factors in adapting to these market dynamics.
– Veklury Was Associated With a Lower Risk of Developing Long-COVID in One Analysis –
– Veklury Was Associated With a Reduced Risk of Mortality Among People Who Are Immunocompromised in a Separate Analysis –
- 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
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
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
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.
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
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.
-
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
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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240304530607/en/
Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Media
public_affairs@gilead.com
Source: Gilead Sciences, Inc.
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