Outcomes of HIV Infection in Persons Who Resume Treatment after Interruptions

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The summary below is from the full report titled "Risk for Opportunistic Disease and Death after Reinitiating Continuous Antiretroviral Therapy in Patients with HIV Previously Receiving Episodic Therapy. A Randomized Trial." It is in the 2 September 2008 issue of Annals of Internal Medicine (volume 149, pages 289-299). The author is the SMART Study Group.

What is the problem and what is known about it so far?

Human immunodeficiency virus (HIV) is the cause of AIDS, an illness that interferes with the body's ability to fight infection and some types of cancer. The body fights infection with the help of CD4⁺ cells, and doctors measure their number in the blood to see how the virus is affecting the body. Higher CD4⁺ cells mean higher immunity, lower levels of infection, and better response to treatment. Doctors usually wait until CD4⁺ cell counts decrease below a certain level to begin a patient's treatment. Then patients continue treatment indefinitely. Treatment causes side effects, however, and there was reason to think that stopping treatment when CD4⁺ cell counts increase and restarting it when counts decrease (interrupted treatment) might help persons avoid some of those side effects. However, a recent study showed that persons receiving interrupted treatment were at greater risk for HIV-related infections and diseases. It is not known whether a person's risk for those infections returns to normal after he or she starts receiving treatment continuously. The question is important because many HIV-infected patients start, stop, and resume treatment even when they are told to take it continuously.

Why did the researchers do this particular study?

To assess the risk for HIV-related infection and illness in persons receiving interrupted treatment who start continuous treatment.

Who was studied?

5472 HIV-infected persons in 33 countries.

How was the study done?

Participants were assigned at random to receive continuous or interrupted treatment. After it became clear that those receiving interrupted treatment had more infections and other diseases, they were told to take treatment continuously. The researchers then followed everyone for 18 months and compared the CD4⁺ cell counts, blood virus levels, and numbers of new HIV-related infections and deaths in the 2 groups.

What did the researchers find?

Blood virus levels and the number of HIV-related infections and deaths decreased, whereas CD4⁺ cell counts increased in persons receiving interrupted treatment who switched to continuous treatment. However, the switch did not entirely eliminate the higher risk for complications. Persons initially receiving interrupted treatment who resumed continuous treatment still had a slightly higher risk for HIV-related infections and death compared with those who had been receiving continuous treatment from the beginning.

What were the limitations of the study?

Researchers could only measure outcomes over about 1.5 years. Because persons with HIV infection now live longer, the findings might be different over a longer period.

What are the implications of the study?

Continuous treatment of HIV infection is better than interrupted treatment. People who start, stop, and resume treatment are at higher risk for complications than those who never stop at all.

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