Two-drug anti-HIV treatment / one GSK tablet is approved in the US by the FDA

The US Food and Drug Administration has approved an HIV treatment consisting of two drugs instead of the usual three, which could give GlaxoSmithKline considerable momentum in its battle for market share with American Biotech, Gilead Sciences.

GSK's new drug, Dovato, will be the first single-tablet, two-drug regimen sanctioned for adults who have never been treated for this disease.

Composed of two drugs, dolutegravir and lamivudine, it follows a series of clinical trials that have shown that two drugs are as effective as three to suppress the virus, with the same result but with less toxicity. .

Gilead currently dominates the entire HIV market, with a value of approximately $ 28 billion, with a market share of approximately 53%, compared with only 22% for GSK.

Deborah Waterhouse, chief executive of ViiV Healthcare, a majority-owned GSK-based HIV treatment company, said the UK drug maker could badert its dominance over its rival thanks to the success of dolutegravir.

In total, 650,000 people worldwide were now on a dolutegravir-based diet. "This is where we think we can take leadership over time and that the two-drug plan is at the heart of the strategy," she added.

We do not believe that a person living with HIV should take more medication than she needs it.

She declined to put an end to this ambition, adding that the company was expecting other clinical data, but added, "The strength of our pipeline would make us believe that the future is very promising."

Therapeutic advances mean that HIV is now for many a chronic disease with which they will live for decades.

Ms. Waterhouse said, "What we are trying to do is to challenge the current treatment paradigm, because we do not believe that people living with HIV should take more medication than necessary.

Patients diagnosed in their 20s or 30s could take medication for 40 years, she explained. "If, during this period, you get to take one of the existing three-drug regimens. . . you will take about 57,000 doses of medication. If you take a two-drug treatment, it reduces to 28,500 doses, "she added.

Surveys have shown that 72% of people living with HIV worry about the long-term effects of HIV treatment and 56% would consider minimizing the number of drugs in their treatment regimen "as long as it's not enough." they would be". risk no problem from the point of view of efficiency, "she added.

advisable

However, some observers believe that doctors may be reluctant to abandon the three long-standing prescriptions for GSK's two-drug version.

Ms. Waterhouse conceded, "You are breaking a treatment paradigm and that means absorption. . . will be a little slower. "

But with sufficiently strong clinical data, doctors would be willing to make this change, she explained.

Ms. Waterhouse stated that while the US approval initially targeted so-called "treatment naïve" patients, who had not yet received any HIV treatment, over time she thought that the regulator would allow the use of treatment in a wider population. In Europe, where approval is expected in the third quarter, the drug should be sanctioned early on for a wider population, she said.

She also suggested that ViiV would exceed the price of Gilead's drug, Biktarvy, saying it would be the most economical treatment in one tablet.