Glaxo arm gets US nod for first 2-drug HIV treatment regimen
22 Nov 2017
The US Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines.
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.
The therapy is one of a growing number of treatment options designed to reduce the number of drugs - and therefore side effects - that people living with HIV need to take in order to suppress the virus.
Juluca belongs to GlaxoSmithKline Plc's majority-owned ViiV Healthcare, in which Pfizer Inc and Shionogi also have small stakes. ViiV's dolutegravir is part of GSK's traditional triple-therapy used to control HIV, while rilpivirine is a Johnson & Johnson drug.
The therapy is the first out of three rival two-drug treatments to receive FDA approval after successful clinical trials.
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 ''one-pill, once-a-day combination'' provides people living with HIV the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen,'' John Pottage, ViiV's chief scientific officer, said in a statement.
The FDA has a February deadline to decide on Gilead's competing combination.
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.
Many researchers are looking to gene and other therapies that might involve a less rigid regimen. Alternatives might include therapies that are injectable or, like Juluca, involve fewer active drugs.
Some patients are already involved in trials. Actor Charlie Sheen, for example, started on a drug called PRO-140 as part of a clinical trial in 2016, and claimed that the weekly injection had kept his virus at undetectable levels.
Sales of GSK HIV medicines rose 26 per cent to $4.25 billion in the first nine months of 2017.