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Elvitegravir use similar in adolescents and adults
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Once-daily elvitegravir — when added to a protease inhibitor-based background regimen — may be as effective and tolerable in adolescents as it is in adults, according to findings presented at the 17th Conference on Retroviruses and Opportunistic Infections, held in San Francisco.
Aditya Gaur, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and Gilead researchers enrolled patients aged 12 to 18 years with a body surface area greater than 1.2 m3 and a weight of at least 40 kg. Those patients were required to have HIV RNA levels >1,000 copies/mL or <400 copies/mL and no prior experience with an integrase inhibitor.
The researchers noted a –2.35 log10 copies/mL change in HIV RNA levels and a median increase of 160 CD4 cells/mcL during the study.
The background regimens of eligible participants included an existing regimen with a ritonavir-boosted protease inhibitor regimen if the HIV RNA level was <400 copies/mL at initial screening. If the HIV RNA level was >1,000 copies/mL, a new regimen that included at least two fully active antiretroviral therapies, including a protease inhibitor, were required. Those studied regimens included elvitegravir (Gilead) 150 mg with darunavir, tipranavir or fosamprenavir, or elvitegravir 85 mg with atazanavir or lopinavir.
The researchers evaluated data for 23 of 25 participants. Although there were no grade four adverse events, the two patients who did not complete the trial did so because of adverse reactions.
The 85-mg formulation of elvitegravir vs. the 150 mg provided comparable area under the curve, Cmax and modestly higher Ctau. The 85-mg elvitegravir plus background also had a higher Ctrough compared with the 150-mg elvitegravir-based regimens. These results are consistent with findings that have been observed in adults.
Nine participants elected to continue the regimen through 48 weeks. Among those patients, seven had reached HIV RNA levels <400 copies/mL by week 16, and six reached levels <50 copies/mL.
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