The Ministry of Food and Drug Safety said Monday it would prohibit combination treatment of MSD’s Stocrin (Ingredient: Efavirenz), a human immunodeficiency virus (HIV) infection treatment, and Zepatier (Ingredient: Elbasvir/Grazoprevir), a hepatitis C virus treatment.

Under its plan, the ministry will add the phrase, “Efavirenz should not be used with Elbasvir/Grazoprevir,” in the usage precaution for Stocrin.

The new ban comes after the U.S. Food and Drug Administration announced the two drugs, if taken together, could reduce the inhibition of chronic hepatitis C virus infection.

Stocrin, approved by the ministry in 2008, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) treatment, which inhibits the self-proliferation of the virus.

Treatment of HIV infection uses the so-called cocktail therapy, which prescribes three antiretroviral drugs. The treatment usually prescribes in two of the nucleoside analog reverse transcriptase inhibitor (NRTI) drugs and combines the treatment with one of the three treatments available – NNRTI, a protease inhibitor, or InSTI.

Recently, companies have started to release a combination drug of these compounds, which has enhanced the convenience of patients.

Zepatier, launched in 2017, is a chronic hepatitis C treatment for genotype 1 and 4, while also including genotype 1b, which is the most common hepatitis C type in Korea. The drug demonstrates therapeutic efficacy in six clinical trials conducted in several countries. Clinical trial results detected no blood virus after 12 weeks of monotherapy.

The ministry will be accepting all comments regarding the change until Feb. 13.

corea022@docdocdoc.co.kr

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