Browsing by Author "Squires, Kathleen"

Now showing 1 - 3 of 3
  • Thumbnail Image
    Item
    Atazanavir—A Once-daily HIV Protease Inhibitor That Does Not Cause Dyslipidemia in Newly Treated Patients: Results from Two Randomized Clinical Trials
    (2004) Cahn, Pedro; Gatell, Jose; Squires, Kathleen; Percival, Lisa D; Piliero, Peter J; Sanne, Ian A; Shelton, Sarah; Lazzarin, Adriano; Odeshoo, Linda; Kelleher, Thomas D; Thiry, Alexandra; Giordano, Michael D; Schnittman, Stephen M
    Protease inhibitor (PI) treatment can result in dyslipidemia in a significant proportion of patients. Atazanavir (ATV) is a once-daily PI that has not been associated with clinically relevant increases in total cholesterol (TC), fasting low-density lipoprotein cholesterol (LDL-C), or fasting triglyceride (TG) concentrations. The objectives of this paper were to evaluate lipid profiles in untreated patients, and investigate the frequency and severity of dyslipidemia in the same individuals after treatment with ATV or nelfinavir (NFV) for 48 weeks. Two multinational, randomized, active-controlled, blinded trials compared the safety and efficacy of ATV and NFV in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) in antiretroviral (ARV)-naive patients. Serum lipid concentrations were analyzed in patients who had available measurements both at baseline and at week 48. Patients who had missing data at either time point were not included. Lipid levels remained within baseline ranges at week 48 with ATV treatment, whereas clinically relevant elevations in TC, fasting LDL-C, and fasting TG concentrations occurred with NFV treatment. Mean changes from pre-treatment baseline in fasting LDL-C ranged from -6 percent to +6 percent in the ATV-treatment groups, and from +27 percent to +31 percent in the NFV-treatment groups. After 48 weeks, there was a substantive increase in the proportion of NFV-treated patients who would be recommended for lipid-lowering treatment by National Cholesterol Education Program (NCEP) guidelines, whereas a lesser proportion of ATV-treated patients would be recommended for lipid-lowering treatment. Atazanavir does not lead to dyslipidemia in ARV-naive patients, and may limit the need for lipid-lowering strategies to reduce the risk of cardiovascular disease.
  • Thumbnail Image
    Item
    Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial Human Immunodeficiency Virus Type 1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial
    (Oxford University Press, 2025-03-13) Rockstroh, Jürgen K.; Paredes, Roger; Cahn, Pedro; Molina, Jean-Michel; Sokhela, Simiso M.; Hinestrosa, Federico; Kassim, Sheetal; Cunningham, Douglas; Ghosn, Jade; Bogner, Johannes R.; Gatanaga, Hiroyuki; Asante-Appiah, Ernest; Zhang, Ying; Nwoke, Uchechukwu; Klopfer, Stephanie O.; Eves, Karen; Squires, Kathleen; Correll, Todd; Fox, Michelle C.; Pisculli, Mary L.
    Background Doravirine/islatravir is an investigational regimen that is being studied for human immunodeficiency virus type 1 (HIV-1) treatment. Methods In this phase 3, double-blind, double-dummy trial (ClinicalTrials.gov NCT04233879), previously untreated adults with HIV-1 were randomized (1:1) and stratified by HIV-1 RNA (≤/>100 000 copies/mL) and CD4 count (
  • 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.