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Raltegravir Efficacy and Safety Similar in Naive Women and Men at 48 Weeks
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4th International Workshop on HIV & Women, January 13-14, 2014, Washington DC
Mark Mascolini
Raltegravir controlled HIV as well in women as in men in an analysis combining data from two double-blind trials of this integrase inhibitor in previously untreated people [1]. A slightly higher proportion of women than men discontinued treatment, more often because of an adverse event than lack of efficacy.
Raltegravir has been licensed for treatment of HIV infection for more than 6 years. To improve understanding of its use in women compared with men, researchers pooled data from two clinical trials that enrolled antiretroviral-naive participants, STARTMRK and QDMRK. From both trials they analyzed only participants who took the licensed dose of 400 mg twice daily. Everyone in the analysis took that dose for at least 48 weeks with tenofovir/emtricitabine.
Among 669 people studied, 144 (21.5%) were women. Age averaged 38.5 years in women and 38.0 years in men. Proportions of whites, blacks, Asians, and Hispanics were 36.8%, 29.2%, 20.1% and 6.3% among women and 63.8%, 9.1%, 7.6%, and 9.7% among men. Women and men had similar pretreatment median viral loads (4.8 and 4.9 log10 copies/mL), and women had somewhat lower pretreatment median CD4 counts (227.5 versus 257.0).
A higher proportion of women than men were infected with an HIV-1 subtype other than B (56.3% versus 14.7%). Higher proportions of women than men lived in Southeast Asia (19.4% versus 5.9%) or southern Africa (11.8% versus 1.1%), while lower proportions of women lived in North America (13.2% versus 29.5%).
A slightly higher proportion of women than men discontinued treatment (11.1% versus 8.2%). A lower proportion of women than men dropped out because of lack of efficacy (0.7% versus 1.7%), while a higher proportion of women quit because of a clinical adverse event (2.8% versus 1.3%).
In an observed failure analysis, similar proportions of women and men had a week-48 viral load below 50 copies (93% versus 91%, difference -3%, 95% confidence interval [CI] -7.4% to 3.0%). Average CD4 gains at week 48 were also similar in women and men (189 and 194, difference 5.3, 95% CI -21 to 31).
Drug-related clinical adverse events affected a marginally higher proportion of women than men (34.7% versus 31.6%). Women had a lower rate of serious clinical adverse events (2.3% versus 8.8%) but a higher rate of serious drug-related events (1.4% versus 0.8%). A higher proportion of women than men stopped treatment because of a clinical adverse event (2.1% versus 1.5%), similar proportions of women and men stopped because of a drug-related clinical event (0.7% and 0.8%), and a higher proportion of women than men quit because of a serious drug-related clinical adverse event (0.7% versus 0.2%).
Proportions of women and men with a drug-related laboratory adverse event were similar (2.8% and 3.2%). No women or men had a serious lab abnormality, and no one stopped treatment because of a lab abnormality.
Women and men did not differ substantially in proportions who reached a grade 3 or 4 predefined limit of change for most laboratory parameters: fasting low-density lipoprotein cholesterol, fasting total cholesterol, fasting triglycerides, total bilirubin, creatinine, or alkaline phosphatase. Higher proportions of men than women had a grade 3 change in fasting glucose (0.6% versus 0%), a grade 3 change in aspartate aminotransferase (2.1% versus 1.4%), a grade 4 change in aspartate aminotransferase (0.8% versus 0%), or a grade 4 change in alanine aminotransferase (1.5% versus 0%).
The researchers believe results of their exploratory analysis "suggest that the efficacy and safety of raltegravir are similar in men and women with previously untreated HIV-1 infection."
Reference
1. Squires K, Bekker LG, Katlama C, et al. The efficacy and safety of raltegravir in women. 4th International Workshop on HIV & Women, January 13-14, 2014, Washington DC. Abstract 17.
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