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12th January 2024
Around 1.4 million more people in the UK will be eligible for antiviral treatment nirmatrelvir plus ritonavir (brand name Paxlovid) if they test positive for Covid-19 after final draft guidance from the National Institute for Health and Care Excellence widens access.
It follows a partial review of the evidence that identified additional groups of people who are at increased risk of severe Covid-19.
Under the recommendations, nirmatrelvir plus ritonavir will be available after a positive Covid-19 test to people aged 85 and over, as well as people who are resident in a care home or are already hospitalised and are aged 70 years and over, have a body mass index greater than 35 kg/m2 or have diabetes or heart failure.
People with end-stage heart failure who have a long-term ventricular assistance device and those on the organ transplant waiting list will also be eligible.
The eligibility is in addition to the 3.9 million people who were already identified as being as increased risk of progression to severe illness if they were infected with Covid-19, NICE said.
Those who are eligible can get free lateral flow tests from participating pharmacies and should take a test as soon as they have symptoms, even if mild, NICE reiterated before calling their GP, NHS 111 or hospital specialist if they test positive.
Helen Knight, director of medicines evaluation said: ‘Our review of the evidence on the use of Paxlovid has found it offers value for money for a wider group of patients.
‘This is good news for people who may contract Covid-19 in the coming months and will help alleviate pressure on the health service.‘
She added: ‘Although we are no longer in a pandemic, Covid-19 is still circulating and we are pleased that more people at risk of severe disease can benefit from Paxlovid.’
Nirmatrelvir plus ritonaviris is an antiviral medicine, given as two separate tablets to people within five days of Covid-19 symptom onset.
Nirmatrelvir stops the virus from growing and spreading, and ritonavir helps nirmatrelvir from being broken down in the body while it is working.
UK public health officials have reported rising levels of winter bugs in the past week with rates of flu, Covid-19 and norovirus continuing to rise.
The latest figures also show a rise in Covid-19 hospitalisations in the last week of 2023 as well as patients admitted to ICU with complications of the virus.
6th April 2023
Nirmatrelvir treatment for patients with COVID-19 has been found to also reduce the risk of developing most post-COVID-19 condition symptoms.
A study by US researchers from St Louis, Missouri has revealed that nirmatrelvir treatment during the acute phase of a COVID-19 infection, reduces the subsequent risk of developing post-COVID-19 condition or long covid.
Post-COVID-19 condition or long COVID is an often debilitating illness that occurs in at least 10% of those infected with the virus and is estimated to affect 65 million people worldwide.
In a clinical trial, nirmatrelvir treatment for symptomatic, unvaccinated, non-hospitalised adults at high risk for progression to severe COVID-19, reduced the risk of disease progression by 89% compared to placebo.
Given that to date, there are no approved treatments for post-COVID-19 condition, it is important to examine whether the use of the available anti-viral therapies are able to reduce the risk of developing the condition.
Thus far, the evidence suggests that COVID-19 vaccines might have protective and therapeutic effects on long COVID, though more robust data are required to confirm this effect.
In the current study, the US researchers examined whether nirmatrelvir (Paxlovid) treatment for COVID-19 was associated with a reduced risk of developing post-COVID-19 condition.
They used a US database to identify patients who had a positive COVID-19 test, who were not hospitalised, had at least one risk factor for progression to severe COVID-19 illness and received oral nirmatrelvir.
This group was then compared to one in which no COVID-19 anti-viral or antibody treatment had been given during the acute phase of their illness.
A total of 281,793 patients with a mean age of 61.9 years (86% male) were treated with the drug.
In comparison to the control group, anti-viral treatment was associated with a 24% reduced risk of developing post-COVID-19 condition (relative risk, RR = 0.74, 95% CI 0.72 – 0.77).
Drug therapy was also associated with reduced risk of post-acute death (Hazard ratio, HR = 0.53, 95% CI 0.46 – 0.61) and post-acute hospitalisation (HR = 0.76, 95% CI, 0.73 – 0.80). Nirmatrelvir treatment was associated with reduced risk of post-COVID-19 condition, in those who were unvaccinated, vaccinated and vaccine boosted, as well as individuals who had a re-infection.
The authors concluded that nirmatrelvir treatment was associated with reduced risk of post-COVID-19 condition regardless of vaccination status and history of prior infection.
Citation
Xie Y et al. Association of Treatment With Nirmatrelvir and the Risk of Post-COVID-19 Condition. JAMA Intern Med 2023.
12th December 2022
The combination of nirmatrelvir and ritonavir appear to be safe and well tolerated when used in pregnancy among mothers infected with COVID-19.
The nirmatrelvir and ritonavir (Paxlovid) can be used safely in pregnant women infected with COVID-19 according to a case series study by researchers from Johns Hopkins University School of Medicine, Baltimore, US.
COVID-19 leads to a consistent and substantial increase in severe maternal morbidity and mortality and neonatal complications in pregnant women.
In fact, available data suggests that severe acute respiratory syndrome caused by COVID-19 during pregnancy leads to placental inflammation and a reduced antiviral antibody response, which could impact upon the efficacy of treatment in pregnancy.
The combination of nirmatrelvir and ritonavir has been authorised by the European Medicine’s Agency for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.
However, the summary of product characteristics states that ‘there are no data from the use of paxlovid in pregnant women’ and that ‘paxlovid is not recommended during pregnancy.’
Despite the lack of human data, animal studies of nirmatrelvir and ritonavir reported no clinically relevant risks associated with administration during pregnancy or in males and females of reproductive age.
In the present study, the US researchers reported on a case series that included pregnant patients who were diagnosed with COVID-19 and who received nirmatrelvir and ritonavir. The team recorded the clinical characteristics and pregnancy outcomes through a manual review of medical records.
A total of 47 women with a median age of 34 years were included and who received the drugs during pregnancy, 57.4% during the third trimester and 34% during the second trimester.
In addition, 85.1% of women had received some level of COVID-19 vaccination, with 44.7% having received the initial series and one booster. Co-morbidities included a mental health disorder (44.7%), obesity (25.5%) and diabetes (10.6%).
A total of 53.2% of mothers delivered after treatment with nirmatrelvir and ritonavir and of whom, 12 (48%) underwent a caesarean delivery, although three quarters of these were scheduled. Only two patients discontinued the drugs due to adverse effects.
Based on these findings, the authors concluded that pregnant patients treated with nirmatrelvir and ritonavir tolerated the treatment although there was an unexpectedly high rate of caesarean deliveries.
They added that the lack of serious adverse effects affecting pregnant patients or offspring suggests that the drug combination is suitable for the treatment of infected, pregnant women.
Citation
Garneau WM et al. Analysis of Clinical Outcomes of Pregnant Patients Treated With Nirmatrelvir and Ritonavir for Acute SARS-CoV-2 Infection. JAMA Netw Open 2022.
6th September 2022
Nirmatrelvir reduced hospitalisations and death among patients 65 years of age or older during the Omicron surge, but no evidence of benefit was found in younger adults, according the results of an analysis by Israeli researchers.
In December 2021, the US FDA authorised Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg or about 88 lb.
The combination was also later approved by the EMA in January 2022.
These approvals arose after publication of data from a Phase II-III double-blind, randomised, controlled trial in which symptomatic, unvaccinated, non-hospitalised adults at high risk for progression to severe COVID-19 were randomised 1:1 to receive either 300mg nirmatrelvir plus 100mg ritonavir or placebo every 12 hours for five days.
The results showed that the risk of progression to severe COVID-19 was 89% lower in the treatment group compared with placebo.
However, while seemingly effective, the main circulating COVID-19 variant at the time of the study was Delta and whether the drug maintained efficacy against subsequent variants of concern such as Omicron was uncertain.
In the present study, researchers used a national health database to identify patients 40 years of age and older and who were deemed to be at a high risk of COVID-19 disease progression and therefore eligible to receive nirmatrelvir.
The team set the primary outcome as hospitalisation due to COVID-19 and COVID-19-related death as the secondary outcome. The study started in January 2022 during which time, the Omicron variant was known to be the dominant strain in Israel.
A total of 109,254 individuals with a mean age of 59.9 years (40% male) were included, of whom 3,902 with a mean age of 67.4 years (40% male) were treated with nirmatrelvir. Overall, 39% of participants were 65 years of age and older and 78% were vaccinated against COVID-19 or had previous immunity due to an infection.
Among those older than 65 given nirmatrelvir, the adjusted hazard ratio (aHR) for hospitalisation was 0.27 (95% CI 0.15 – 0.49) and the risk of a subsequent COVID-19-related death was also significantly lower (aHR = 0.21, 95% 0.05 – 0.82).
But when researchers looked at those aged 40 to 64 years, the adjusted HR for hospitalisation was not significant (aHR = 0.74, 95% CI 0.35 – 1.58) and neither was the risk of COVID-19-related death (aHR = 1.32, 95% CI 0.16 – 10.75).
In subgroup analysis based on previous immunity, the risk for hospitalisation among those aged 40 to 64 years remained non-significant for both without (aHR = 0.23, 95% CI 0.03 – 1.67) and with (aHR = 1.13, 95% CI 0.50 – 2.58) prior immunity.
In contrast, there were significant benefits for patients 65 years and older, irrespective of whether or not they had prior immunity.
The authors concluded that during the Omicron variant surge, there were benefits for older patients administered nirmatrelvir, but it did not provide a benefit for those under 65 years of age in terms of either hospitalisation or death.
Citation
Arbel R et al. Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge. N Engl J Med 2022.
24th February 2022
Giving oral nirmatrelvir and ritonavir to patients with COVID-19 within three days of symptom onset and a potentially high risk for disease progression has been shown to reduce that risk by 89% compared to placebo. This was the conclusion of a randomised trial by the manufacturer, Pfizer.
While the introduction of COVID-19 vaccines have led to a significant reduction in the level of hospitalisation of patients, many individuals with risk factors remain at an increased risk of more severe disease. In a 2021 meta-analysis, it was concluded that patients with hypertension, obesity, diabetes and cardiovascular disease had more COVID-19 severity and mortality respectively. Given the existence of these factors, it is necessary to have treatments which can halt the progression of an infection to more severe disease, shorten the recovery period and ultimately reduce the burden on healthcare systems.
Within the COVID-19 virus, the enzyme 3-chymotrypsin–like cysteine protease (Mpro) is vital for replication and oral nirmatrelvir is an anti-viral agent which targets this enzyme. Moreover, research has shown that nirmatrelvir is metabolised by CYP3A4 and that addition of a low dose of ritonavir, favourably enhanced nirmatrelvir pharmacokinetics.
For the present Phase II-III randomised trial, the authors evaluated the combination of oral nirmatrelvir 300mg and 100mg of ritonavir every 12 hours for 5 days, in non-hospitalised adults with mild-to-moderate COVID-19 but who also had risk factors for progression to severe disease. Enrolled patients were randomised 1:1 to the treatment combination or matching placebo. The primary objective of the trial was to compare the proportion of patients with COVID-19 hospitalised or who died over a 28 day period after randomisation, compared to placebo. This comparison was made at two time-points: after three and five days of treatment.
Oral nirmatrelvir and COVID-19 outcomes
A total of 2246 patients with a median age of 46 years (51.1% male) were randomised to active treatment (1120) or placebo. The most common coexisting conditions associated with a risk of progression to severe COVID-19 were a BMI of 25 or above (80.5%), current smoking (39.0%) and hypertension (32.9%). In addition, 61.0% of participants had two or more coexisting conditions.
In the final analysis, among 1379 patients treated with oral nirmatrelivir and ritonavir and placebo, within less than 3 days of symptom onset, 5 patients in the nirmatrelivir and ritonavir group and 44 in the placebo arm, were hospitalised for COVID-19 or died within 28 days. This corresponded to an 88.9% relative risk reduction in the primary objective. When patients were treated less than 5 days after the onset of symptoms, 0.77% of the oral nirmatrelvir and ritonavir group and 6.31% of the placebo group met the primary outcome, giving a relative risk reduction of 87.8%.
Data on the viral load in both groups showed that when treatment was started within 3 days of symptom onset, the load was 10-times lower in the oral nirmatrelvir and ritonavir group compared to placebo. In addition, the incidence of adverse effects was similar between the two groups.
The authors concluded that treatment with oral nirmatrelvir and ritonavir early in COVID-19 illness, reduced disease progression and viral load.
Citation
Hammond J et al. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19 N Engl J Med 2022
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