The pandemic has revealed the need for new formulas in health matters. The emergency that supposes the treatment of 2.9 million contagious in the last week in the world, 21% in Africa, according to the last WHO report. The US pharmacist Merck announced last Wednesday an agreement that could allow the generic versions of his drug against Covid-19 for people infected by the disease are widely available in poor countries when regulatory agencies give you green light.
Merck has blusted with the Drug Patent Bank (MPP) a voluntary license agreement to facilitate affordable global access to the MOLNUPIRAVIR. Subject to regulatory approval, the Agreement will help provide ample access in 105 low and middle-income countries. The United Kingdom announced this Thursday that it is the first country in the world to authorize the MOLNUPIRAVIR. The US drug regulatory agencies and the European Union, FDA and EMA, have already initiated an evaluation of the drug. The latter gave green light yesterday to the Member States to use it under the emergency path.
This is a response to the expectation that the antiviral that can become the first and only oral drug indicated for initial phases of the COVID-19. About the possibility of treating patients ambulatory and preventing them from progressing to more serious phases. On October 1, American companies MSD and Ridgeback Biotherapeutics announced in a press release that its antiviral had reduced a 50% risk of hospitalization or death in non-hospitalized adult patients with mild to moderate and at least one factor of risk of progressing to serious illness.
The results come from an interim analysis of phase III Move-Out assay, which showed that, at 29 days from randomization, 14.1% of patients treated with placebo (53/377) were hospitalized or died, in Comparison with 7.3% of hospitalizations Among the patients who received MOLNUPIRAVIR (28/385), since no deaths were reported in the antiviral group and yes eight in the placebo.
The trial was carried out in non-vaccinated patients, who had begun to experience symptoms in the 5 days prior to the start of treatment. All had a risk factor, such as more than 60 years, obesity, diabetes or heart disease, among others. In 40% of the patients included in the analysis there were viral sequencing data, which demonstrated that the drug was effective against the Gamma, Delta and Mu variants, and its safety profile was comparable to placebo.
Since MSD Spain, its medical director, Joaquín Mateos, qualifies the results of "very relevant". He explains that, if approved, the treatment would be taken for five days, twice a day, and that it is important to begin the antiviral in the first five days since the symptoms began. "In this time window, patients are usually treated to come to primary care for a diagnosis for their symptom picture".
EMA and FDA have already started the continuous review of the information available on the compound for the authorization of emergency use. The North American regulator has convened a meeting on November 30 with its Advisory Committee to help you adopt a decision on the approval of the medication and under what conditions it could be used. "There is a need to have effective antiviral drugs for the treatment of COVID-19", warns Antonio Valllano, coordinator of the Pharmacotherapeutic Harmonization Program of Catalan Health and Spokesman Service of the Spanish Society of Clinical Pharmacology (SEFC).
At the moment, the only antiviral authorized in the treatment of the Covid-19 is remdden, "whose results have been the occasion of a great debate and discussion on the clinical relevance of its effectiveness. In addition, other antivirals that were initially used, such as Lopinavir / Ritonavir, Subsequently it was demonstrated that they were not effective, "highlights the pharmacologist.
The eventual availability of MOLNUPIRAVIR would cover a lagoon in the approach of the Covid-19, coincides José Ramón Arribas, Chief of Internal Medicine of the Hospital La Paz (Madrid) and expert from the Spanish Society of Infectious Diseases and Clinical Microbiology (Seimc). "One of the unresolved needs is to have an antiviral in the first days of the disease, which is when viral replication is the cause of most of the damage. In order to work it has to be used in the first days of the disease, And this has global implications: For many countries it must have an adequate price and, although it is, if there is difficulty accessing the diagnostic tests, it may not be useful, "alert.
The need to stick to this five-day temporary framework also "supposes an important limitation in a country like Spain", interprets Jesús Sierra, head of rational use of the pharmacy of Jerez Hospital de la Frontera and spokesman for Spanish Society of Hospital Pharmacy (SEFH). For Sierra, it is very likely that the confirmation of positive cases of Covid-19 is delaying beyond these five days with symptoms, due to the high rate of immunization of the population, which has reduced fear of Covid-19. Likewise, because SARS-COV-2 infection can be confused with catarrier frames caused by other less dangerous respiratory pathogens.
In a country like Spain, the hospital pharmacist arises "what is the actual applicability of the Move-Out results in risk patients. Because, perhaps, with vaccines, the reduction of the risk of hospitalization with MOLNUPIRAVIR instead of being From 14% to 7% become 6% to 3% ".
The expert insists on the importance of knowing the detail of the Phase III clinical trial results to determine if there is an individual benefit from the drug in population subgroups by risk factors. Likewise, and at the margin of the drug, but closely related to its potential use, it considers that "it must be a priority to know what is the real rate of Covid-19 serious in vaccinated people, and their relationship with risk factors."
But for arrives it would not make sense a very restricted use in Spain: "Although it is very likely that infection is milder in vaccinated patients, at the present time, before a positive patient and risk factors, it would not make sense to make a distinction Between vaccinates and not vaccinated, because there is an opportunity window in the first five days since the beginning of symptoms and hospitals we find that there are patients with serious vaccine failures. "
Another unknown is the potential risk of resistance development. Since MSD report that "the short duration of the treatment, five days, gives the virus few opportunities to evolve towards resistant forms." In the Move-Out it did not give signs of weakness before the variants and as Sierra, it is foreseeable that its effectiveness is maintained due to its broad-spectrum antiviral action. For this reason, "it is a medication that could be used in the case that some variant would emerge that compromised the protection of vaccines," he observes. "Molpunavir acts as a competitive substrate of the coded RNA-dependent RNA (RDRP) by SARS-COV-2, and induces an antiviral effect through the accumulation of mutations with each viral replication cycle. Preclinical studies reveal a Antiviral activity of wide spectrum against coronavirus, including SARS-COV-2, with a high barrier to resistance, "says Vellano.
Date Of Update: 08 November 2021, 18:54
