"At Least 4 Days of No Sexual Intercourse"... Precautions for Taking Oral COVID-19 Medication Revealed

Expert: "Pregnancy May Cause Congenital Defects"

Oral antiviral drug for COVID-19 'Molnupiravir' developed by American pharmaceutical company Merck / Photo by Yonhap News

[Asia Economy Reporter Kang Juhee] The oral antiviral drug for COVID-19, "Molnupiravir," developed by the U.S. pharmaceutical company Merck, which has applied for emergency use authorization from the U.S. Food and Drug Administration (FDA), includes a "prohibition of sexual intercourse" criterion as part of the eligibility requirements for clinical trial participation, drawing attention.

According to the clinical trial information disclosure by the U.S. National Institutes of Health (NIH) on the 7th (local time), Merck specified the prohibition of sexual intercourse as a restriction in the eligibility criteria for participation in the trial of this drug.

Merck stated that for men, "they must agree to maintain abstinence during the drug administration period and for at least 4 days after the last dose, and agree to use contraception." For women, it stated, "They must not be pregnant or breastfeeding, and there must be no possibility of pregnancy."

Merck also excluded from the clinical trial △certain cases with kidney disease △HIV-infected individuals who have shown stable responses to antiretroviral therapy △those with a history of cirrhosis, terminal illness, hepatocellular carcinoma, or some cases of hepatitis B or C △those with platelet counts below 100,000/μL (microliter) within 5 days or who have received platelet transfusions.

Regarding this, Professor Simon Clarke of the University of Reading in the UK explained, "It is noteworthy that clinical trial participants were instructed to abstain from sexual intercourse or use contraception," adding, "This is a common practice with some other drugs such as cancer chemotherapy because if pregnancy occurs, the drug may cause congenital malformations."

He further commented on the drug's COVID-19 treatment, saying, "It would be good if it prevents 50% of patients from worsening to severe conditions, but hospitalization rates remain high despite taking the drug," and "It is impossible to know who will recover or worsen."

Merck attracted attention by announcing interim results of its Phase 3 clinical trial on the 1st, showing that molnupiravir reduced hospitalization and mortality rates by about half in COVID-19 patients. The clinical trial involved 775 patients with mild to moderate COVID-19 within 5 days of infection, and among those who took molnupiravir, only 7.3% were hospitalized, and there were no deaths.

Meanwhile, the government announced on the 5th that it is negotiating with Merck, Pfizer, and Swiss pharmaceutical company Roche to purchase oral COVID-19 treatments and has already secured at least 20,000 doses.

The government allocated a total of 36.2 billion KRW for the purchase of oral treatments, including 16.8 billion KRW from this year's supplementary budget and 19.4 billion KRW from next year's government budget. The Korea Disease Control and Prevention Agency stated that it plans to reflect the cost of purchasing treatments for 18,000 people in this year's supplementary budget and for 20,000 people in next year's budget proposal.

This content was produced with the assistance of AI translation services.