WHO includes oral antiviral molnupiravir in Covid-19 treatment guidelines

Invites manufacturers to submit products for pre-qualification

The World Health Organisation (WHO) has included oral antiviral drug molnupiravir in its Covid19 treatment guidelines, with a conditional recommendation for this medicine. It has also invited manufacturers to submit their products for prequalification, with a number of manufacturers of molnupiravir going through assessment now. Meanwhile, WHO has recommended against the use of remdesivir in hospitalized patients.

This could be good news for Indian manufacturers of molnupiravir. After the antiviral oral drug got the nod from the Drugs Controller General of India (DCGI), Balram Bhargava, director general of the Indian Council of Medical Research (ICMR) had said that the medicine is not included in national clinical protocol as there were serious safety concerns. Bhargava had said molnupiravir had serious safety concerns - it can cause teratogenicity (is the ability to cause defects in a developing foetus), mutagenicity , and it can also cause cartilage damage and can also be damaging to muscles. Mutagenicity refers to permanent transmissible changes in the structure of genetic material of cells.

The global health watchdog has recommended active monitoring for drug safety along with other ‘strategies to mitigate potential harms’

WHO has updated its living guidelines on Covid19 therapeutics to include a conditional recommendation on molnupiravir, a new antiviral medicine, a statement said.

“This is the first oral antiviral drug to be included in the treatment guidelines for COVID-19. As this is a new medicine, there is little safety data. WHO recommends active monitoring for drug safety, along with other strategies to mitigate potential harms,” it read.

Because of these concerns and data gaps, molnupiravir should be provided only to non-severe COVID-19 patients with the highest risk of hospitalization, WHO said. These are typically people who have not received a COVID-19 vaccination, older people, people with immunodeficiencies and people living with chronic diseases.

Children, and pregnant and breastfeeding women should not be given the drug, WHO has said. People who take molnupiravir should have a contraceptive plan, and health systems should ensure access to pregnancy testing and contraceptives at the point of care.

Under the care of a health care provider, molnupiravir, an oral tablet, is given as four tablets (total 800 mg) twice daily for five days; within 5 days of symptom onset.

“Today’s recommendation is based on new data from six randomized controlled trials involving 4,796 patients. This is the largest dataset on this drug so far,” WHO said.

WHO has also invited manufacturers to submit their products for prequalification, with a number of manufacturers of molnupiravir going through assessment now. “WHO evaluates the quality, safety and efficacy of medical products for United Nations and other large suppliers to low- and middle-income countries. More WHO quality-assured manufacturers mean that countries have a greater choice of products and more competitive prices,” it said.