Paxlovid ‘Cinderella’ of the Covid cure? We used 20% of what was purchased but now the expiry date of the lots is 24 months

by Barbara DiChiara

The Government purchased 600,000 doses last year but as of March 7, around 120,000 patients have been treated with this therapy. This drug has remained the only one considered truly effective and well tolerated in the therapeutic arsenal of doctors, confirms Fimmg. However, he complains about a lack of clarity in the political indications on whether or not to consider Covid still as a priority and an emergency.

20 MAR –

Antivirals against Covid-19, the ‘Cinderella’ of Italian healthcare? It’s true, the situation in our country is under control: the Sars-CoV-2 virus is less scary. But by consulting the monitoring data activated by the Italian Medicines Agency (Aifa) on the use of these drugs, and taking the drug as a point of reference paxlovid, of which the Italian Government purchased 600,000 doses last year, as of March 7, approximately 120,000 patients have been treated with this therapy. The good news is that the company was able to extend the expiration date of the many lots of the antiviral still available for use in Italy by 6 months, after the go-ahead from the European Medicines Agency (EMA).

“We wish to inform you – reads the communication addressed to prescribers dated February 2023 – that the package of Paxlovid that has been delivered to you has an out-of-date expiry date on the package. Therefore, if the expiry date has passed to date, this does not mean that the product is to be considered expired. Indeed, on 24 January 2023 the European Medicines Agency (EMA) approved a new shelf life for Paxlovid (nirmatrelvir/ritonavir), extending it from 18 months to 2 years. This means that packages with an expiry date between November 2022 and November 2023 on the box and blister remain valid for a longer period than the printed expiry date. This shelf life extension applies to medicine manufactured after the approval date of the current change, as well as retrospectively to all batches of Paxlovid manufactured prior to the approval date of January 24, 2023.”

Another important element is that with the approval of the new period of validity, the conservation conditions have also been changed. The sentence previously reported in the SPC “Do not store above 25 °C. Do not refrigerate or freeze” was changed to: “This medicinal product does not require any special storage conditions”.

“Everything would suggest that there are ideal conditions for an increase in the use of this antiviral – explains a Health newspaper Pierluigi Bartoletti, deputy secretary of the Italian Federation of General Practitioners (Fimmg) – which, moreover, has remained the only ‘weapon’ against Covid-19: molnupiravir has been suspended for a few days due to lack of efficacy, monoclonal antibodies are equally ineffective results. While paxlovid is a drug that is very well tolerated and gives excellent results. In unsuspecting times, in December, in a webinar organized by us with 280 family doctors, we understood that none of them had doubts about the efficacy and safety of the drug, but that there was little familiarity in identifying and pigeonholing the subjects at risk of serious illness, those for whom this medicine is indicated. But I think that in recent months the situation is going better, with an increase in prescriptions in recent months according to the AIFA treatment plan. Problems relating to patients with kidney disease are also easily manageable, because we general practitioners know our patients well and the prescription can be done safely. For possible interactions, we have software that helps us identify possible risk situations, which in my experience are very few. A clear message, however, should come from political decision-makers, who must tell us whether the attention on Covid must remain high or not, and what we must do to ensure this”.

Barbara DiChiara

March 20, 2023
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