Israel approves generic HIV drug to treat COVID-19 despite doubts

TEL AVIV/CHICAGO (Reuters) - Israel approved the licensing of a generic version of an HIV drug to treat patients infected with the coronavirus on Thursday, despite doubts about its effectiveness in trials.

The anti-viral drug Kaletra, produced by AbbVie Inc, could be a possible treatment for COVID-19, Israel’s Health Ministry said after issuing a preliminary permit.

While AbbVie’s patent for Kaletra in Israel ends in 2024, the patent in some other countries, such as India, has expired.

It was the first time the country’s attorney general has allowed the use of a generic version of a patent-protected drug in Israel, where there are 529 confirmed coronavirus cases.

“The company with the patent and the official importer in Israel are not able to supply the necessary inventory for this drug, which is very much in demand all over the world these days,” the Justice Ministry said in a statement.

“Therefore ... the state will be able to import generic substitutes from countries where the patent has expired.”

It said generic Kaletra will only be used to treat coronavirus and not HIV, to protect the patent holder.

A study released on Wednesday in the New England Journal of Medicine found that the drug was not effective as a potential treatment for coronavirus.

The test of Chinese patients with severe COVID-19 found the 99 who received Kaletra, a combination of HIV drugs lopinavir and ritonavir, fared no better than the 100 who received standard care.

Those on the drugs showed clinical improvement after a median of 15 days compared to 16 days with standard care, a difference researchers said was “significant, albeit modest”.

Johnson & Johnson has been testing a similar HIV drug, known as a protease inhibitor, against the novel coronavirus.

At a panel on Thursday organized by the International Federation of Pharmaceutical Manufacturers and Associations, Paul Stoffels, J&J’s chief scientific officer, said its HIV drug Prezista, does not appear to have any effect against COVID-19.

“We know from our scientific work that there is no activity on COVID-19,” Stoffels told reporters. “It’s highly unlikely there is any benefit of protease inhibitors,” he added.

He discouraged the use of HIV drugs to treat COVID-19 patients if they are proven to be ineffective.

“People with HIV will be deprived of medicine if it used in a non-necessary way in this outbreak.”

Reporting by Steven Scheer and Julie Steenhuysen; Editing by Tova Cohen and Alexander Smith