Safety Board Recommends Study Participants With High Viral Loads Consider Switching From GSK’s Antiretroviral Epzicom to Gilead’s Truvada
An independent data and safety monitoring board on Thursday recommended that HIV-positive people with high viral loads who are taking part in a clinical trial consider switching from GlaxoSmithKline's antiretroviral drug Epzicom to Gilead Sciences' Truvada, Reuters reports.
The recommendations come after the board recently found that among HIV-positive people with high viral loads taking part in the clinical trial, treatment regimens containing Epzicom were less effective at controlling viral loads than regimens containing Truvada. The AIDS Clinical Trials Group of NIH's National Institute of Allergy and Infectious Diseases is conducting the comparison trial among 1,858 HIV-positive people, Reuters reports. The board also found that participants with high viral loads treated with Epzicom developed side effects, such as body aches and high cholesterol, faster than people on the Truvada regimen. The trial recommendation applies to about half of the participants being treated with Epzicom. The board said it had no other safety concerns regarding the drug, adding that participants who have lower viral loads should continue their assigned regimens.
GSK in a statement said that the NIH study did not routinely exclude patients at risk for a known reaction with Epzicom, which could have caused some of the side effects. Gilead spokesperson Amy Flood said, "We think this is an important result ... it reinforces the profile of Truvada."
Thomas Russo, an analyst at Robert W. Baird, said the NIH trial recommendations follow an update earlier this month from a Danish observational study that suggested a link between abacavir and an increased risk of heart attack. Epzicom is a combination of abacavir, or Ziagen, and lamivudine, or Epivir, according to Reuters. Russo added, "These issues could lead doctors to reconsider abacavir-based regimens in favor of regimens based on Gilead's market-leading" Viread, which in combination with the company's antiretroviral Emtriva comprise Truvada (Beasley, Reuters, 2/28).