"COVID-19 response has changed to protect high risk groups"

Essy Mozaffari, Gilead Sciences Medical Affairs

Highlights the need to transition infectious disease management from COVID-19 to SARS-CoV-2

COVID-19 treatments have been reimbursed since October of last year…increased utility for high-risk groups

"Veklury is an important treatment option with demonstrated effects in different viral mutations"

As COVID-19 transitioned to the endemic phase, an important issue has arisen regarding 'how' to prevent and respond to the disease, unlike the initial period focused only on response.

 

One of the big changes was the reimbursement of treatments.

 

On October 25, 2024, The Ministry of Health and Welfare (MOHW) approved the National Health Insurance reimbursement of the COVID-19 treatments, Veklury and Paxlovid.

 

Based on the demands of clinical settings, the government aims to provide a stable supply of COVID-19 treatments to patients through the National Health Insurance system.

 

In another point of view regarding infectious disease management in the endemic period, experts are highlighting the need to revisit the discussion of 'SARS-CoV-2,' which is one of the respiratory viruses other than COVID-19.

 

Essy Mozaffari, Gilead Sciences Medical Affairs

During the meeting with Daily Pharm, Essy Mozaffari, affiliated with the Gilead Sciences Medical Affairs, emphasized the role of antiviral therapy in protecting immune-compromised individuals and high-risk patients.

 

In February 2020, the WHO officially announced the name for COVID-19, and at the same time, it assigned the name SARS-CoV-2 to the virus.

 

It means that corona 19 (COVID-19) is typically used when discussing symptoms, whereas the SARS-CoV-2 virus causes the infection.

 

Medical Affairs Mozaffari (hereafter, MA) said, "At the current endemic phase, it is crucial that we discuss SARS-CoV-2 infection rather than using the term COVID-19," adding that, "If SARS-CoV-2 is used to describe the virus, it will help remind that it is a virus that can make people ill every year." The latest COVID-19 responses have focused on immune-compromised individuals and high-risk patient groups, who can be relatively vulnerable to a disease.

 

The approach has been limiting the spread of the disease through immunization and providing treatments to infected individuals in a timely manner.

 

For instance, the COVID-19 treatment Veklury (remdesivir) is the first antiviral agent to receive approval from the U.S.

 

FDA for the treatment of hospitalized adult patients with COVID-19.

 

Veklury is now recommended as the standard therapy for adults and children who are hospitalized due to SARS-CoV-2 infection.

 

Also, it is recommended for use in non-hospitalized patients with mild and moderate symptoms who are at risk of advancing to severe COVID-19.

 

MA Mozaffari stated, "Although there are many antiviral therapies, Veklury has low drug interaction, so it is an important treatment option for patients who must take other medicines.

 

Patients who have liver and spleen dysfunction can use the therapy without adjusting the dosage." "Veklury with real-world evidence demonstrated effects in high-risk patient group" MA Mozaffari particularly highlighted that Veklury has proven real-world evidence (RWE) in hospitalized patients due to COVID-19.

 

"The Phase 3 PINETREE trial involving high-risk non-hospitalized patients infected with SARS-CoV-2 has shown that administering Veklury for three days decreased the hospitalization risk," MA Mozaffari said.

 

"The recent real-world data (RWD) confirmed that the use of Veklury in the high-risk patient group, including immune-compromised individuals and older patients aged 65 and above, significantly lowered the death risk compared to the control group in all mutation periods.

 

MA Mozaffari views that proper management of infection through treatments can benefit the efficient management of the medical healthcare system as medical healthcare system resources are being spent on managing immune-compromised individuals.

 

"COVID-19 infection causes a significant burden to the medical healthcare system consistently, and it poses a risk of disease progression and death in older people aged 65 and above," MA Mozaffari said.

 

"Antiviral therapies with proven treatment effects for various COVID-19 mutations will play a crucial role in future COVID-19 treatments." Now, Gilead Sciences is conducting research on the potential use of Veklury in a particular patient group with unmet needs for COVID-19 treatments.

 

The company is evaluating the effects of Veklury treatment in new mutations as COVID-19 vaccines target changes.

 

"Based on trial results so far, Veklury continued to maintain treatment effects on all mutations, including omicron sub-variants.

 

Notably, there have been no key genetic changes affecting targeted RNA polymerase of the virus," MA Mozaffari explained.

 

The results indicate that mutations to the virus will not cause significant changes to RNA structure and function, so the therapy can continue to work effectively," MA Mozaffari analyses.

 

Lastly, MA Mozaffari mentioned the concern for effective responses amid COVID-19 settling down as an endemic disease.

 

"COVID-19 is now transitioned to endemic disease, but SARS-CoV-2 continues to pose significant health risk worldwide," MA Mozaffari said.

 

"The government, researchers, doctors, and individuals must strive to maintain the infection rate low and stay alert to respond to new mutations effectively."