First 2-drug HIV regimen approved by FDA

first 2 drug HIV regimen approved by FDA

The first two-drug program has been approved by U.S. Food and Drug Administration (FDA) for the treatment of AIDS-causing virus. This drug plan aimed at easing up the side effects of the standard treatment processes that involve three or more drugs, especially in case of long-term patients.

The two-drug treatment is known as Juluca. This comprises a fixed dose of a combination of two drugs, viz., viz. dolutegravir and rilpivirine, that had been already approved by FDA. This treatment is available to patients, who are on a stable treatment plan for at least six months.

Juluca is manufactured by ViiV Healthcare, whose major shareholder is GlaxoSmithKline (GSK) with Pfizer and Shionogi being the minor shareholders. GSK has a traditional triple therapy for the treatment of HIV and dolutegravir is a part of it.

The approval of Juluca has put GSK a rank higher to its competitor, Gilead Sciences in the 2-drug combination market for HIV treatment. However, there are speculations that Juluca will cover the market a bit slower, because the drug rilpivirine has some limitations as it can only be taken with the meal at the same time every day.


GSK is now working on a new two-drug combination in which the rilpivirine can be replaced with a drug called 3TC. It is estimated that this combination will be in the market by the second half of 2019, but only after successful clinical trials.