Swallow pills and thus prevent a severe course of Covid 19: What sounds promising at first has still had a few snags in practice.
Berlin – One million packs ordered for Germany and high effectiveness against severe Covid 19 courses: After several vaccines and medications, the delivery of a preparation in Germany began last week, which at first glance could be considered a way out of the pandemic.
The tablets in question are called Paxlovid and come from the US pharmaceutical company Pfizer. They aim to inhibit virus multiplication in the body. The drug has been conditionally approved in the EU since the end of January, and doctors in Germany have been able to prescribe it for a few days. It can also be taken at home.
No magic bullet
The first data sound promising: The treatment with the two active ingredients (nirmatrelvir/ritonavir) led to an 89 percent lower risk of a severe course of Covid 19 compared to a dummy drug, according to the study on Paxlovid in the journal “The New England Journal of Medicine”.
However, when asked by dpa, experts emphasized that one should not rely on a supposed miracle cure to protect against intensive care units or death instead of vaccination. “Paxlovid is not the way to overcome the pandemic, but the vaccination,” said the German Society for General and Family Medicine (DEGAM). With Paxlovid you have “a last resort”: its use requires extreme caution and good patient education and monitoring. The drug comes into consideration for a small group of people: “for the unvaccinated over 65 years of age who have not yet recovered”.
Study and effectiveness of the drug
Two groups were compared for the study: while around 1,100 people infected with Sars-CoV-2 received Paxlovid every 12 hours for five days, the second group received a dummy drug. Around a dozen deaths occurred in the placebo group, while none of the subjects treated with the drug died. Only adults in the early phase of infection and with risk factors such as overweight or high blood pressure could take part in the study. The authors write that side effects such as taste disorders, diarrhea and vomiting were not serious.
The study was carried out before the discovery of Omikron. However, it is assumed that it is effective against these and other Sars-CoV-2 variants. “This also applies to omicron subtype BA.2, which is currently spreading,” said the expert from the German Society for Pneumology and Respiratory Medicine (DGP), Stefan Kluge. He coordinates the guideline with recommendations for inpatient treatment of Covid 19 patients.
In general, Kluge states: “Paxlovid is not a panacea.” Nevertheless, he expects a relevant number of patients who could be treated with it within five days of the onset of symptoms: According to the present study, the drug is only suitable for patients without vaccination protection with at least one risk factor , which also includes an age of 50 and over. “Based on previous data, it is not a drug for, for example, slim, athletic 20-year-olds or 60-year-olds with a booster who get a positive test result,” said Kluge. So far, there is no reliable data on use in vaccinated people in general.
interactions and problems
With regard to the early start of treatment, the professor from the University Hospital Hamburg-Eppendorf points out the problem that many patients do not go to the doctor immediately and that it also takes time for the test results to be available. Because of the urgency required, according to the Federal Union of German Pharmacists’ Associations, it is planned that doctors will exceptionally send prescriptions directly to pharmacies, which will then order the drug from wholesalers and deliver it to patients “with as little contact as possible” by messenger. “Pharmacies are not allowed to stock Paxlovid,” it said.
Another catch are possible interactions with a number of other drugs, such as for high blood pressure, cancer, depression or to treat other infections. This is likely to make prescribing more difficult, especially for patients who are particularly at risk. Experts like Kluge urge that the risk of interactions be checked. In the leaflet, patients are asked to show their doctor and pharmacist a list of their medicines.
The federal chairman of the German General Practitioners Association, Ulrich Weigeldt, welcomed the progress in the development of Covid 19 drugs. “According to the current state of knowledge, however, we do not expect Paxlovid to be widely used in family doctor’s practices.” DEGAM also announced that demand and prescription are currently “a marginal phenomenon” in family doctor care. However, experts also point out that luckily, thanks to the vaccinations and the generally milder omicron variant, the courses are generally much less severe.
Paxlovid is not the first drug to protect outpatients in the early phase of Sars-CoV-2 infection from severe courses. So-called monoclonal antibodies, for example, have been given for a long time – usually as an infusion. In addition to Paxlovid, the recently updated therapy guideline also mentions the active ingredients remdesivir and molnupiravir. However, they are not suitable for all patient groups. And here too, early administration is considered crucial for the success of the treatment. dpa
