Antivirals against Covid-19 will soon be available in pharmacies
This is why Aifa seems determined to change the rules for accessing these drugs: soon a prescription from the family doctor will be enough, and the pills can be picked up directly at the pharmacy. A revolution that, hopefully, will help to further improve the current epidemic situation, and could prove to be fundamental in the autumn, with the onset of the new cold season and the probable flashback of the pandemic. So let's see how the rules change, which drugs are available and their effects.
The European Medicines Agency gives the green light to Paxlovid, Pfizer's anti Covid-19 treatment It is the first antiviral medicine to be administered orally recommended in the European Union for the treatment of Covid-19. Use is recommended for adults. The recommendation goes to the Commission for definitive authorization Anti Covid drugs-19 The first antiviral to arrive on the market was Remdesivir. An intravenous drug, which must therefore be used in a hospital setting or in any case with the involvement of healthcare personnel. It was initially approved only for patients already hospitalized and undergoing oxygen therapy, in the case of a high risk of worsening the disease. Now it can also be used for non-hospitalized high-risk patients, up to seven days after the onset of symptoms. In this case, the new AIFA directives will not change the situation, since the methods of use of the drug do not allow self-administration.
The situation is different in the case of the two new antiviral pills arrived in recent months. The first to be approved was molnupiravir, which has been available since late December. Followed by paxlovid, who arrived in Italy in February. In both cases, these are medicines that must be taken within five days of the onset of symptoms in non-hospitalized patients, to reduce (with different efficacy) the risk of the disease progressing to more severe forms.
Until now, family doctors (or the Usca) had to report patients potentially eligible for therapy to the specialists of the centers identified by the regions, who in the event of a positive evaluation would prescribe the drugs. The medicines were then collected from the hospital pharmacies of the regional centers. A laborious path, which has evidently contributed to curbing the use of the two antivirals, given that the time window for starting therapy is narrow, and every bottleneck in the prescription process is obviously destined to reduce the number of patients who manage to access drugs in time. Not surprisingly, the latest Aifa report speaks of about 16 thousand administrations for molnupiravir (out of a total of about 50 thousand treatments purchased from our country), and just 6,800 for paxlovid.
Aifa's green light to a new path of access to antivirals, expected in these days, should change the situation for the better. As far as it is possible to understand, family doctors should be provided with treatment plans which specify how to select patients eligible for therapy. With these they will be able to prescribe the drug themselves, with the possibility probably of requesting a specialist consultation to keep side effects and interactions with other molecules under control, and patients will be able to collect it directly in their local pharmacies. A few hours of waiting between the positive swab and the start of therapy, which could finally push the number of treatments up.
Covid-19, here is the (small) fleet of antivirals: what they are and how they work The distribution of molnupiravir in Italy has just started, the first oral antiviral against coronavirus, which is added to remdesivir. Here's how the antiviral front is changing, not without perplexity. How effective are they? Turning to the results obtained with antivirals, each molecule makes its own story. We had already talked about remdesivir in the past. The data on efficacy in hospitalized patients are contradictory, and in any case not too encouraging, so much so that WHO has continued to express a negative opinion on its use. More recently, a study published in the New England Journal of Medicine evaluated the efficacy of the drug in case of early administration in non-hospitalized patients at increased risk of disease progression. The results speak of 0.7% of patients hospitalized after taking remdesivir versus 5.3% in the control group that received placebo, for a relative risk reduction of 87%.
As for molnupiravir, the data are far more disappointing. It was initially announced that it was approximately 50% effective in avoiding hospitalizations and deaths. But the definitive results of the main trial, which arrived in December, significantly reduced the provisional estimates, concluding that the effectiveness of molnupiravir does not reach 30%. Out of about 700 patients, 48 hospitalizations with the drug were recorded, and one death was recorded, for placebo just 68 hospitalizations and 9 deaths. Aifa also took note of the bad performance of molnupiravir, so much so that the rumors of recent days would indicate that the therapeutic plan for the prescription by family doctors for this drug will probably not even be presented, and it will progressively be abandoned. use in the next few months.
The most brilliant results are those of the latest addition: the paxlovid. The data from the trial carried out by the manufacturer have been published in recent days, and concern over two thousand patients randomized to receive the drug (or rather, the combination of two molecules, nirmatrelvir and ritonavir, which makes up the therapy) or a placebo. At the end of the trial, 8 out of 1,039 patients were hospitalized or died in the treatment group, while 66 out of 1046 in the control group. The absolute risk of hospitalization or death for paxlovid was 0.7%, while for placebo we are talking about 6.3%, for a relative risk reduction of 87.8%.
Does China's “zero Covid” strategy still make sense? While most of the world tries to live with the virus, the country continues to pursue a zero tolerance policy undaunted, with increasingly heavy consequences on the population. Costs and effectiveness The only oral antiviral that demonstrates a certain effectiveness, we have seen it, is the paxlovid. And it is probably this drug that is destined to see its use significantly increase in the coming months with the changes in prescription and distribution of the drug announced by AIFA. At the moment, Italy seems to have optioned about 600,000 treatments, which should arrive in stages over the next few months. We bought around 50,000 for molnupiravir, and it seems plausible that we won't be buying many more in the near future. The cost is 610 per cycle, for a total cost of around 30 million euros.
Paxlovid has a similar cost, even if Pfizer, the manufacturing company, has prevented the disclosure of the details of the agreement reached with the commissioner of General Figliuolo. In the Corriere della Sera, Milena Gabanelli estimated € 666 per cycle of therapy, a figure that would bring the total investment for 2022 to approximately 400 million. A lot of money, which we hope will help to further reduce the weight of this pandemic in the coming months . Provided, of course, our health system is finally able to offer these drugs to all patients who need them.
