Fast-track system for combination anti-AIDS drug use welcomed

The Global AIDS Fund on Monday welcomed a move by the US Health and Human Services department to facilitate the wider use of fixed-dose combination anti-AIDS drugs in developing countries.

A major scaling up of HIV/AIDS treatment is currently being financed by the Fund in over 100 developing countries, where simplified drug regimens play a crucial role in bringing about more rapid expansion and improved compliance.

Research has shown that people on anti-AIDS treatment were able to reduce their pill consumption to as little as one tablet twice a day as a result of fixed-dose combination drugs.

Although only generic drug companies are producing the fixed-dose combinations, the prospects for a wider selection of these drugs becoming available were improved earlier this week when three major US pharmaceutical companies Bristol-Meyers Squibb, Gilead Sciences and Merck and Company said plans were underway to develop a fixed-dose combination of three of their anti-AIDS medicines.

The executive director of the Global Fund, Richard Feachem, lauded efforts by additional companies taking up the challenge by collaborating to create new solutions.

Feachem said in a statement: "Simpler drug regimens can save lives and prevent the spread of resistance to HIV drugs. I am delighted that the research muscle of big pharma is now being applied to expand the number of fixed dose combinations and securing their effectiveness. This is reassuring and will bring benefits to people in all countries."

A recently announced fast-track review by the US Food and Drug Administration (FDA) is also expected to reduce the time needed for approval of these combinations to as little as a few weeks.

"Recipients of Global Fund grants already have the opportunity to buy generic fixed-dose combinations but, clearly, FDA approval of these drugs would lead many more countries to choose them," Feachem noted.

The Fund also welcomed an announcement by US Global AIDS Coordinator Randall Tobias that under the President's Emergency Plan for AIDS Relief, drug patent issues applied in developed nations should not impede the purchase of these drugs.

"The fact that the President's Emergency Plan also will allow the use of these drugs makes it much easier to harmonise drug protocols in countries where both the Global Fund and the President's Emergency Plan finance drug purchases. It is important that patients can expect the same drugs, no matter who they go to," said Feachem.