Browsing by Author "Marlink, Richard"

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    Antiretroviral Drugs for Preventing Mother-to-Child Transmission of HIV: A Review of Potential Effects on HIV-Exposed but Uninfected Children
    (2011) Heidari, Shirin; Mofenson, Lynne; Cotton, Mark F.; Marlink, Richard; Cahn, Pedro; Katabira, Elly
    Objective Antiretroviral drugs (ARVs) can prevent HIV mother-to-child transmission (PMTCT), but in utero ARV exposure may be associated with neurologic symptoms due to mitochondrial toxicity (MT). We sought to identify the currently recommended PMTCT regimen that optimally balances risks of pediatric HIV infection and neurologic MT. Design Published MTCT and MT data were used in a decision analytic model of MTCT among women in sub-Saharan Africa. Methods We investigated the HIV and MT risks associated with no ARV prophylaxis and five recommended regimens ranging from single-dose nevirapine to 3-drug ART. Sensitivity analyses varied all parameters, including infant feeding strategy and the disability of MT relative to HIV. Results Provision of no ARVs is the least effective and least toxic strategy, with 18-month HIV risk of 30.4% and MT risk of 0.2% (breastfed infants). With increasing drug number and duration, HIV risk decreases markedly (to 4.9% with 3-drug ART), but MT risk also increases (to 2.2%, also with 3-drug ART). Despite increased toxicity, 3-drug ART minimizes total adverse pediatric outcomes (HIV plus MT), unless the highest published risks are true for both HIV and MT, or the disability from MT exceeds 6.4 times that of HIV infection. Conclusions The risk of pediatric MT from effective PMTCT regimens is at least an order of magnitude lower than the risk of HIV infection associated with less effective regimens. Concern regarding MT should not currently limit the use of 3-drug ART for PMTCT where it is available.
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    Gender-sensitive reporting in medical research
    (2012) Heidari, Shirin; Abdool Karim, Quarraisha; Auerbach, Judith D.; Buitendijk, Simone E.; Cahn, Pedro; Curno, Mirjam J.; Hankins, Catherine; Katabira, Elly; Kippax, Susan; Marlink, Richard; Marsh, Jennifer; Marusic, Ana; Nass, Heidi M.; Montaner, Julio; Pollitzer, Elizabeth; Ruiz-Cantero, Maria Teresa; Sherr, Lorraine; Papa Salif Sow; Squires, Kathleen; Wainberg, Mark A.
    Sex and gender differences influence the health and wellbeing of men and women. Although studies have drawn attention to observed differences between women and men across diseases, remarkably little research has been pursued to systematically investigate these underlying sex differences. Women continue to be underrepresented in clinical trials, and even in studies in which both men and women participate, systematic analysis of data to identify potential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensure provision of complete, transparent and critical information. An important step in addressing the gender imbalance would be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT) guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethical obligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promoters of ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses should be integrated into editorial policies as a matter of urgency.