In targeting HIV, the virus that causes AIDS, a new mix of drugs works as well as a traditional drug combination used for initial treatment of infection, a new study shows.
The new drug combination is “not inferior” to the established mix, the researchers write in The New England Journal of Medicine.
In the study, more patients taking the new drug combination suppressed HIV to very low levels and had fewer cases of certain side effects, compared with those taking the older mix of drugs.
The findings apply to people with HIV who haven’t already taken antiretroviral drugs, note the researchers. They included Joel Gallant, MD, of the infectious diseases division at Johns Hopkins University School of Medicine.
“Both treatments are effective,” Gallant says in a news release.
“The implications are quite clear for patients with HIV who are about to start therapy,” he says. “The simple combination of [Viread, Emtriva, and Sustiva] is likely to be highly potent with minimal side effects or long-term toxicity.”
According to the CDC, more than a million people in the U.S. were living with HIV/AIDS by the end of 2003, and roughly one in four weren’t aware that they had HIV. Every year, about 40,000 people in the U.S. become infected with HIV.
Two Combinations Tested
Here are the drug combinations that were tested:
—New mix: Sustiva, Viread, and Emtriva
—Older mix: Sustiva and Combivir
All of the medications tested in the study are currently available. Treating HIV takes multiple drugs because the virus is good at learning to resist medications. Attacking HIV with different drugs at the same time is intended to overwhelm the virus and avoid drug resistance.
Viread and Emtriva are newer HIV drugs. Viread was approved by the FDA in 2001; Emtriva got FDA approval in 2003. Combivir contains two older HIV medicines (AZT and 3TC) and is available as a generic drug.
Each pill in the new combination is taken once daily. One of the drugs in the older combination (Combivir) is taken twice daily.
The study included about 500 people with HIV. None had taken antiretroviral drugs before. They were randomly assigned to take the new or older drug combination for about a year.
The main goal was to see which group did better at suppressing HIV to very low levels.
Slightly more patients taking the new combination of drugs reached that goal (84 percent, compared with 73 percent of those taking the older drug combination).
The most common side effects in both groups included dizziness, nausea, and diarrhea. Similar numbers of patients in both groups had those problems.
However, anemia was less common and nausea was more common with the new drug combination, the study shows.
In a subgroup of patients, those taking the new drug combination lost less fat from their limbs during the study. Loss of limb fat is a known complication of some HIV drugs that can lead to disfigured body shapes, states a Johns Hopkins news release.
It’s not yet known if those results will hold beyond a year’s time, the researchers note in the journal.
The study was designed by Gilead Sciences, Viread’s maker. In the journal, several of the researchers, including Gallant, note ties to various drug companies, including the makers of drugs tested in the studies.
By Miranda Hitti, reviewed by Louise Chang, MD
SOURCES: Gallant, J. The New England Journal of Medicine, Jan. 19, 2006; vol 354: pp 251-260. CDC, Division of HIV/AIDS Prevention: “Basic Statistics.” WebMD Medical News: “World AIDS Day: HIV Pandemic Surging.” FDA Talk Paper: “Viread,” Oct. 29, 2001. FDA: “Consumer Drug Information Sheet: Emtriva.” News release, Johns Hopkins Medical Institutions.