FDA approves first 2-drug HIV regimen
{{#rendered}} {{/rendered}}25 percent of people diagnosed with HIV in 2015 were infected for seven years or more before being diagnosed. (iStock)
The U.S. Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at easing the side effects for long-term patients who are on the standard treatment involving three or more drugs.
The treatment, called Juluca, is a fixed-dose tablet that combines two previously approved drugs, dolutegravir and rilpivirine, and is available to patients who have been on a stable regimen for at least six months.
Juluca belongs to GlaxoSmithKline Plc's majority-owned ViiV Healthcare, in which Pfizer and Shionogi also have small stakes. ViiV's dolutegravir is part of GSK's traditional triple-therapy used to control the AIDS virus.
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The approval puts GSK ahead of rival Gilead Sciences in the race to market with two-drug combinations for HIV treatments, although uptake could be slow because rilpivirine has the downside that it must be taken with a meal at the same time every day.
The FDA has a February deadline to decide on Gilead's competing combination.
{{#rendered}} {{/rendered}}GSK is also working on a second two-drug combination that will replace rilpivirine with a common off-patent drug called 3TC that could reach the market in the second half of 2019 if clinical trials are successful.