Are There Any Risks Associated with Raltegravir HD?

Pedro Cahn, MD, Chief, Infectious Disease Unit, Juan A. Fernandez Hospital; and lead study investigator for the onceMRK Phase 3 clinical trial, describes the risk associated with raltegravir HD.

Interview Transcript (modified slightly for readability):

“Not at all. Raltegravir is the best-known integrase-inhibitor in the time that we have been using it, and there is no additional risk by using it once-a-day because the core of the drug is the same. The galenic formulation is different to allow for the drug to be used as 2 pills, at 600 mg, once-a-day.

For the few patients that failed [treatment during the onceMRK study], the selection of resistance was tiny and was no different in the once-a-day than in the twice-a-day. Some of my colleagues may ask, ‘If I use it once-a-day, am I putting my patients at risk of selection of resistance?’ This is not the case. A total of 0.8% selection of resistance was shown in each arm. These numbers are very similar to prior raltegravir studies. [The drug] is safe and more convenient.

Raltegravir initially was launched after the results of the benchmark studies that were done in patients severely exposed to antiretroviral therapy, having failed [treatment] with 3 different classes. For the first time, patients with very advanced disease and very advanced failure could achieve undetectable viral load when raltegravir was combined with other drugs. After that, raltegravir was tested in AIDS patients in a trial, and this gave way to the use of raltegravir as a first-line treatment. And, so, raltegravir can be used across the whole spectrum of disease.”