Browsing by Author "Wainberg, Mark A."

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    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.
  • Thumbnail Image
    Item
    Resistance profile of the new nucleoside reverse transcriptase inhibitor apricitabine
    (2009) Cahn, Pedro; Wainberg, Mark A.
    Apricitabine is a novel deoxycytidine nucleoside reverse transcriptase inhibitor (NRTI) currently in clinical development for the treatment of HIV infection. Apricitabine shows antiviral activity in vitro against HIV-1 strains and clinical isolates with mutations in the reverse transcriptase that confer resistance to other NRTIs, including M184V, thymidine analogue mutations (TAMs), nucleoside-associated mutations such as L74V and certain mutations at codon 69. Apricitabine has shown activity in treatment-experienced HIV-1-infected patients with NRTI resistance (with M184V and up to five TAMs) as well as in treatment-naive patients. Resistance to apricitabine is slow to develop in vitro and there has been little evidence of development of resistance to apricitabine in clinical use thus far, including patients receiving apricitabine for up to 48 weeks. The resistance profile of apricitabine suggests there is a low potential for cross-resistance with the currently available NRTIs and, thus, apricitabine may provide a treatment option for treatment-experienced HIV-1-infected patients with resistance to other NRTIs. In particular, the activity of apricitabine in the presence of the M184V mutation, which confers high-level resistance to lamivudine and emtricitabine, lends it to being used as a replacement for deoxycytidine analogues in patients who have failed treatment with lamivudine or emtricitabine.