New impetus on the treatment front is expected from the anti-Covid pills soon available in Italy. The moment imagined by the former Ema executive director and consultant to the extraordinary commissioner for the Covid emergency Guido Rasi is early January. But beyond the modalities of use in the account we must inevitably keep an availability problem. «Merck’s product is only 30% effective in hospitalization, but the Pfizer pill achieves 90% effectiveness, avoids hospitalizations. This is great news, ”explained White House immunologist and chief medical advisor Anthony Fauci. “The only issue is that there are no large supplies of it, so we have to increase production because there will be great demand for this product, because it is very effective.”
The methods of recruitment
In the European context, national authorities could decide on the possible early use of Pfizer’s drug Paxlovid even before the actual authorization, for example in emergency contexts, in light of the increase in infection rates and deaths due to Covid throughout the world. ‘EU. Based on the opinion delivered by the CHMP Committee for Medicinal Products for Human Use and communicated by the EU regulatory body, treatment is reserved for adults with Covid-19 who do not require supplemental oxygen and who are at greater risk of progression to a serious disease. In addition, the drug should be administered as soon as possible after diagnosis and in any case within 5 days of the onset of symptoms.
Proven effectiveness
The two active substances of the medicine, PF-07321332 and ritonavir, available as separate tablets, should be taken together twice a day for 5 days. The Ema indication on the use of the Pfizer pill is based on the interim results of the main study conducted on non-hospitalized and unvaccinated patients who had a symptomatic disease and at least one underlying condition that put them at risk of severe Covid. These data – the agency details – showed that Paxlovid reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms. About 1% of patients (6 out of 607) who took the drug were hospitalized within 28 days of starting treatment compared with 6.7% of patients (41 out of 612) who were given placebo ( fictitious treatment); none of the patients in the treated group died, compared with 10 patients in the placebo group. In terms of safety, the most common side effects reported during treatment and up to 34 days after the last dose were dysgeusia (taste disturbances), diarrhea and vomiting.
No to use in pregnancy
Paxlovid should not be used with some other medicines – explains Ema – both because due to its action it can lead to harmful increases in their blood levels, and because on the contrary some drugs can reduce the activity of Paxlovid itself. The list is included in the proposed terms of use. The anti-Covid pill should also not be used in patients with severely reduced kidney or liver function. Paxlovid is not recommended during pregnancy, but also in women who are not using contraceptives and can become pregnant. These recommendations are due to the fact that laboratory studies in animals suggest that high doses of the drug may have an impact on the growth of the fetus.
Garattini: good but we need treatment for advanced disease
According to Silvio Garattini, president of the Mario Negri Irccs Institute of Pharmacological Research, other weapons are also needed to mark a definitive turning point against Covid-19. Pfizer’s “is certainly an active drug but what we need is not only and not so much these drugs that do a bit what the vaccine would do, but drugs that act when there is the disease and it has moved on “. In short, we need a “game changer” capable of treating in the later stages, “when the Covid disease is now in action”. It is “early to talk about an anti-Covid pill” according to the consultant of the Minister of Health Walter Ricciardi, who at beraking latest news Health reiterates the need “not to rush too much, but to wait” also on Pfizer’s Paxlovid antiviral that could arrive . Also in 2022 “the strategy to be followed is that of vaccinations and precautions that we know by now”.