3 New COVID-19 Treatments Now Available to MS Patients in UK
People with multiple sclerosis (MS) living in the U.K. are now eligible to receive one of three new treatments for COVID-19 that are meant to prevent serious disease in at-risk populations who tested positive for the virus.
First available under this plan were Regeneron and Roche’s antibody-based therapy Ronapreve (casirivimab/imdevimab), and the antiviral pill Lagevrio (molnupiravir), developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme (MSD; known as Merck in North America). Xevudy (sotrovimab), an antibody developed by GSK and Vir Biotechnology, also was recently added to the list.
“The rollout of monoclonal antibodies and antivirals represents another weapon in our arsenal to reduce the risk of patients at highest risk [of] becoming seriously ill and needing hospitalization from COVID-19,” Stephen Powis, the national medical director of NHS England and a professor of renal medicine at the University College London, said in a press release.
According to the National Health Service: “This will ensure the treatments can help protect those most at risk from the virus over the winter months, reducing the number of hospitalisations and therefore pressures on the NHS.”
Still, Powis added, “getting vaccinated is the best way to protect you and your loved ones from COVID-19 and I would urge everyone to come forward to get vaccinated — whether that’s your first, second or booster jab.”
Given directly into the bloodstream or through an under-the-skin (subcutaneous) injection, Ronapreve is a combination of two monoclonal antibodies, casirivimab and imdevimab, that target SARS-CoV-2, the virus causing COVID-19.
Specifically, these antibodies bind to the virus’ spike protein at two different sites, preventing it from entering human cells and consequentially stopping COVID-19 infection.
In a placebo-controlled Phase 3 clinical trial (NCT04425629) — involving people with at least one risk factor for severe COVID-19 and whose symptoms began up to seven days earlier — into-the-vein (intravenous) Ronapreve was shown to reduce the combined risk of hospital admission or death by 70%. It also accelerated symptom recovery by four days.
Positive results also were observed in another placebo-controlled Phase 3 trial (NCT04452318) testing Ronapreve as a preventive under-the-skin therapy in people who had been exposed to the virus by someone in their household. In this trial, Ronapreve reduced the risk of COVID-19 development by 81%.
Based on these findings, Ronapreve was conditionally approved in the U.K. to treat and prevent COVID-19 infection in adults and children ages 12 and older who are at risk for progression to severe COVID-19. The therapy also was approved in Europe, and authorized for emergency use in the U.S., where it is sold as REGEN-COV, for the same indication.
Lagevrio, given orally as a five-day course, was designed to lower the levels of SARS-CoV-2 circulating in the body by causing an accumulation of mutations in the virus’ genetic material that limit its ability to make copies of itself.
Data from a Phase 2/3 trial, called MOVe-OUT (NCT04575597), showed that Lagevrio, given within five days after symptom onset, significantly reduced the risk of hospital admission and death by about 30% relative to a placebo in adults with mild to moderate COVID-19 and at least one risk factor for severe disease.
The antiviral medication is approved in the U.K. for adults with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as being older than 60, having other health conditions, such as MS, or being immunocompromised.
Notably, MS patients on some immunosuppressive treatments can have compromised immune systems, which may limit the effectiveness of COVID-19 vaccines.
While Lagevrio is not yet approved in Europe, the European Medicines Agency has supported its use for the same indication. A regulatory decision in the U.S. is also awaited, but a panel of experts in America recommended the therapy’s approval.
Xevudy is another antibody-based therapy with a similar mechanism of action as Ronapreve — it binds to the spike protein outside the virus, preventing it from attaching to and entering human cells.
The approvals for Xevudy were supported by data from the COMET-ICE Phase 3 trial (NCT04545060), in which a single dose of Xevudy reduced the risk of hospital admission and death by 79%, per an additional analysis that has not yet been peer-reviewed.
MS patients in the U.K. are expected to be informed that they are eligible for these treatments via a letter or email from the country’s National Health Service, known as the NHS. All those eligible will be given a PCR test to keep at home so that they can do testing as soon as possible if they develop COVID-19 symptoms.
Individuals who receive a positive test will be further assessed over the phone by an expert clinician from an NHS COVID Medicines Delivery Unit (CMDU), who will review and discuss with the patient the most appropriate treatment.
Those being prescribed Ronapreve or Xevudy will be invited to visit a CMDU — set up by the NHS since the summer — while those prescribed Lagevrio can either get someone to collect the medication for them or have it delivered to their home.
In its announcement, the U.K.’s MS Society emphasized that it has asked the NHS for more information on how patients’ safety will be safeguarded in their travels to the CDMU.
The society also recommended that patients call their general practitioner (GP) or 111 if they are not contacted by a CMDU clinician within 24 hours of a positive PCR test.
These new treatments are expected to help prevent serious COVID-19 infections during the coming cold-weather months in at-risk populations, which is hoped to reduce the number of hospitalizations among people with MS and other co-existing medical conditions.
People living in the U.K. and receiving a positive PCR test for COVID-19 also may receive Lagevrio within a national platform trial, called PANORAMIC. Platform trials test several medications simultaneously to reduce the costs and time of finding effective therapies.
Run by the University of Oxford and funded by the National Institute for Health Research, the trial aims to recruit up to 10,000 people — those 50 and older, and adults younger than 50 with an underlying health condition that puts them at a higher risk of severe COVID-19. Eligible patients must have also developed symptoms within the five days prior to enrollment.
Potential participants may be contacted by the study team or their GP to enroll in the trial; they also can sign up themselves through the trial’s website.
PANORAMIC participants will be randomly assigned to receive standard care either alone or in combination with Lagevrio, which will be taken at home.
Patients also will be asked to complete a daily diary of symptoms and medical care received for 28 days (just short of a month) via the study’s website or through phone calls from the trial team. At three and six months after the study start, patients will be contacted and asked about long-term COVID-19 symptoms.
The trial’s first set of results is expected in early 2022.
In the future, other antiviral therapies may be added to the trial, researchers said.