Dolutegravir in Treatment-Experienced People Who Have Not Previously Used an Integrase Inhibitor
Complications and Side Effects
Rates of side effects were similar whether participants were taking dolutegravir or raltegravir. There are at least two possible reasons for this. First, as a class, integrase inhibitors are generally well tolerated. Secondly, the background regimens for nearly all participants were combinations of protease inhibitors. These drugs can cause a range of side effects, mostly affecting the gastrointestinal tract (nausea, vomiting, diarrhea). Such side effects may have dwarfed any, more minor side effects that may have occurred with exposure to integrase inhibitors. Researchers noted that, in general, side effects were mostly of mild-to-moderate intensity.
No deaths occurred among participants who received dolutegravir. Although there were three deaths among raltegravir users, investigators found that none were caused by raltegravir (two cases of unrelated cancer and one case of multi-organ failure).
Some commonly reported side effects appear below. Bear in mind that many participants were taking complex regimens, so it is difficult to connect exposure to the study drugs with specific side effects.
Severely Abnormal Lab Test Results
ALT (alanine aminotransferase -- a liver enzyme)
Higher-than-normal blood sugar
Elevated levels of creatine phosphokinase (CPK)
For the Future
Dolutegravir is expected to be approved as part of combination therapy for HIV-positive people in the U.S. by September and in Canada later this year.
A future issue of TreatmentUpdate will explore the issue of kidney health and dolutegravir.
Cahn P, Pozniak A, Mingrone, et al. Dolutegravir is superior to raltegravir in ART-experienced, integrase-naïve subjects: week 48 results from Sailing (ING111762). In: Program and abstracts of the 7th IAS Conference on Pathogenesis, Treatment and Prevention, 30 June to 3 July, 2013, Kuala Lumpur, Malaysia. Abstract WELBB03.
This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
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