New Drugs, New Strategies for HIV in the United States and Europe

The Food and Drug Administration approved Tivicay, a new once-daily HIV medication.

For more than 30 years, researchers and pharmaceutical companies have raced to develop HIV medications that can slow the development of full-blown AIDS and help people living with HIV live longer, healthier lives. But longer lifespans for people living with HIV can pose a new set of challenges: people can become resistant to medications over time, and may need to change their drug regimens to respond.

Last week, the U.S. Food and Drug Administration (FDA) approved a new once-daily pill for HIV, Tivicay, part of a new class of anti-HIV drugs. During a clinical trial, the drug reduced HIV to undetectable levels in more people living with the virus as compared to the world’s most-used HIV medication, Atripla.  In addition, the FDA announced that it would follow new guidelines intended to expedite the approval process for new HIV medications by cutting down on the number of once-mandatory follow-up studies for HIV drugs.

Dr. Laura Guay, vice president of research at the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), says that these advances reflect new realities for people living with HIV in resource-rich regions liked the United States or Western Europe, where HIV medications are widely available.

“People living with HIV may develop resistance or intolerance to one or more of the drugs in their treatment regimen and have to switch to another one,” she said. “The longer you stay on medications, the more likely it becomes that you will need new treatment regimens.” 

In addition, Dr. Guay says that there is a need to continue to develop new drugs like Tivicay that are more effective, have fewer side effects, less resistance, and allow less frequent dosing. Dr. Guay said that new classes of drugs can target the virus in different places and during different stages of its lifecycle to make the drug regimens more effective for patients.

The new FDA guidelines will put newly-approved drugs on the market more quickly and keep a continual supply of new drugs in the pipeline. These advances are creating new options for people living with HIV, particularly the 1.1 million Americans living with the virus. In addition, the FDA’s new guidelines will accelerate the drug development process and make more drugs available to more people.

Jane Coaston is Media Relations Coordinator for the Foundation, based in Washington, D.C.

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