February 9, 2010

HIV Treatment Success in Everyday Clinics Is Comparable to Rates in Clinical Trials

People with HIV can achieve just as much benefit from treatment in “real world” clinics as they do in clinical trials, according to a University of Alabama at Birmingham (UAB) study published February 15 in Clinical Infectious Diseases and reported by aidsmap.

Historically, HIV treatment success rates have been higher in clinical trials than in everyday care. Experts say this is partly due to the high level of follow-up that occurs during a clinical trial. Also, it is generally assumed that people who are allowed into clinical trials tend to be more motivated to adhere to treatment and that they have fewer non-HIV problems—such as mental illness and concurrent illicit drug use—that can hinder treatment success.

To determine whether people starting antiretroviral (ARV) therapy in everyday care would be as likely to achieve treatment success as people in clinical trials, Justin Routman, BA, and his colleagues from UAB evaluated ARV efficacy rates at the university’s 1917 HIV clinic in Birmingham. Routman’s group compared the results with those involving patients enrolled in clinical trials.

In all, 570 people in routine care started ARV therapy between January 2000 and December 2006, while 121 started ARV therapy through a clinical trial.

The study participants were similar in most characteristics, though black participants were more likely to receive treatment in routine care than white participants, and people who started treatment through a clinical trial tended to have higher CD4 counts than people who started HIV treatment as part of their routine care.

Rates of treatment success, defined as a viral load less than 50 copies, were similar between the two groups. After six months of treatment, 66 percent of those receiving treatment at the 1917 Clinic achieved a viral load of less than 50 copies, compared with 71 percent who received treatment as part of a clinical trial. After 12 months of treatment, 67 percent in everyday care had treatment success compared with 73 percent in a clinical trial. The difference between the two groups was not statistically significant, meaning that it was small enough to have occurred by chance.

When Routman and his colleagues conducted a sensitivity analysis of the data, where a missing viral load result was counted as a treatment failure, the difference between the two groups did become statistically significant, with those receiving treatment through a clinical trial doing better than those in everyday care. The authors, however, suggest that the difference was likely not due to actual treatment failure, but simply to a greater likelihood that people in routine care were more likely to miss appointments.

“These findings provide insight into the efficacy [of ARV therapy] and suggest that, in the contemporary treatment era, similar first-year responses are observed in treatment naive patients who start [treatment] in clinical trials and in those who start [treatment] in routine care,” the authors conclude.

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