Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis

Thu, 16 Jan 2020 00:00:00 GMT-06:00 - Eron, Joseph; Hung, Chien-Ching; Baril, Jean-Guy; Slim, Jihad; Falcó, Vicenç; Bogner, Johannes; Maggiolo, Franco; Mills, Anthony; Sievers, Jârg; Man, Choy Y.; Urbaityte, Rimgaile; Underwood, Mark; Tenorio, Allan R.; Pappa, Keith A.; Wynne, Brian; Koteff, Justin; Gartland, Martin; Smith, Kimberly Y.; Aboud, Michael
Εισαγωγή: To investigate antiviral potency of the 2-drug regimen (2DR) dolutegravir plus lamivudine vs the 3-drug regimen (3DR) dolutegravir plus tenofovir disoproxil fumarate/emtricitabine, we performed a post hoc analysis assessing antiviral response rates in the phase III GEMINI-1 and GEMINI-2 studies by baseline viral load (VL). Setting: 192 centers in 21 countries.
Μέθοδοι: Treatment-naive HIV–infected participants with screening VL <500,000 copies/mL were randomized 1:1 to once-daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log10-transformed VL in the overall study population and the subpopulation with baseline VL >100,000 copies/mL. Proportion of participants achieving plasma VL <50 copies/mL (Snapshot algorithm) or <40 copies/mL (Abbott RealTime HIV assay) and target not detected (TND) was assessed through Week 48 by baseline VL. Time to viral suppression was determined (non-parametric Kaplan-Meier method).
Αποτελέσματα: For 293 participants with baseline VL >100,000 copies/mL, median change from baseline at Week 4 was βˆ’3.38 and βˆ’3.40 log10 copies/mL in the 2DR and 3DR groups, respectively; reduction was sustained throughout 48 weeks. Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups. Proportion of participants with VL <50 or <40 copies/mL and TND was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.
Συμπέρασμα: Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive HIV–infected individuals across baseline VL strata. Correspondence and reprint requests to: Joseph Eron, University of North Carolina at Chapel Hill School of Medicine, CB# 7030, Bioinformatics Building, 130 Mason Farm Road, 2nd Floor, Chapel Hill, NC 27599-7030, Phone: 919-966-2537, E-mail: joseph_eron@med.unc.edu Conflicts of Interest and Source of Funding: Joseph Eron has received honoraria for consulting for Merck, ViiV Healthcare, Janssen, and Gilead Sciences. The University of North Carolina receives research support for clinical trials for which Dr Eron is an investigator. Chien-Ching Hung has received honoraria for speaking at educational events or consulting for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and ViiV Healthcare and has received research funding from Bristol-Myers Squibb, Janssen, Gilead Sciences, Merck, and ViiV Healthcare. Jean-Guy Baril has received honoraria for consulting for ViiV Healthcare, Merck, and Gilead Sciences and for participation as a speaker at conferences from Merck and Gilead Sciences. His institution, Clinique MΓ©dicale du Quartier Latin, has received research grants from GlaxoSmithKline, Merck, and Gilead Sciences. VicenΓ§ FalcΓ³ has received honoraria for speaking at educational events from Janssen, Merck, and ViiV Healthcare and has received research funding from Gilead Sciences, Merck, and ViiV Healthcare. Johannes Bogner has received personal fees for participation as a speaker from AbbVie, Gilead, Janssen, Merck, Hexal, and ViiV Healthcare and for participation in advisory boards from Gilead, Janssen, Merck, and ViiV Healthcare. Franco Maggiolo has received research funding from ViiV Healthcare, Gilead Sciences, Merck, Janssen, and AbbVie and has received personal fees for participation in advisory boards from ViiV Healthcare, Gilead Sciences, and Merck. Anthony Mills has received honoraria for consulting for Merck, ViiV Healthcare, Janssen, and Gilead Sciences. The Men’s Health Foundation receives research support for clinical trials for which Dr Mills is an investigator. JΓΆrg Sievers, Choy Y. Man, Mark Underwood, Allan Tenorio, Keith A. Pappa, Brian Wynne, Justin Koteff, Martin Gartland, Kimberly Y. Smith, and Michael Aboud are employees of ViiV Healthcare and own stock in GlaxoSmithKline. Rimgaile Urbaityte is an employee of GlaxoSmithKline and owns stock in GlaxoSmithKline. Jihad Slim has no conflicts to disclose. This study was funded by ViiV Healthcare. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. - Β© 2020

Recurrence of Anal High-Grade Squamous Intraepithelial Lesions among Women Living with HIV

Thu, 16 Jan 2020 00:00:00 GMT-06:00 - Stier, Elizabeth A; Abbasi, Wafaa; Agyemang, Amma F.; Valle Álvarez, Eduardo Amílkar; Chiao, Elizabeth Y; Deshmukh, Ashish A
Εισαγωγή: Women living with HIV (WLHIV) have a high risk of developing invasive anal cancer. Anal cancer may be prevented with early detection and treatment of anal histologic high-grade squamous intraepithelial lesions (HSIL). However, there is limited data on the efficacy of anal HSIL treatment in WLHIV. Study Design: We conducted a retrospective study of WLHIV treated for anal HSIL under high resolution anoscopy (HRA) guidance from January 1st, 2007 to December 31st, 2017 with at least one post treatment visit at an urban tertiary care hospital.
Αποτελέσματα: 45 WLHIV women with at least 1 follow-up evaluation after treatment for anal HSIL were identified. The median age was 46 years (range 35-66 years), 63% were African American, 27% were Hispanic/Latino, and 53% were current smokers. The mean absolute CD4+ T-cell count was 516 cells/mm3; 50% and 24% of the cohort had a history of cervical or vulvar HSIL respectively. The cumulative probability of anal HSIL recurrence was 29% at 12 months, 52% at 24 months, and 79% at 36 months post-treatment.
Συμπέρασμα: The majority of WLHIV treated for anal HSIL recurred within 3 years suggesting need for continued surveillance following treatment. Our data contributes to the information needed to develop effective anal cancer prevention guidelines in WLHIV. Corresponding Author: Elizabeth A. Stier, MD Associate Professor, Department of Obstetrics and Gynecology Boston Medical Center/Boston University School of Medicine 85 East Concord St. 6th floor Boston, MA 02118 Phone: 1-617-414-3167 Fax: 1-617 414 7300 elstier@bu.edu The authors report no conflicts of interest related to this work. * These authors contributed equally to the work # Center for Immunotherapy, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA † Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA Previously presented at American Society for Colposcopy and Cervical Pathology Biennial Meeting, Atlanta, 4/2019. Financial Support: This work was supported by the National Cancer Institute of the National Institutes of Health (UM1CA121947, (principal investigator: Dr Ronald Mitsuyasu)); and from Boston University, CTSI 1UL1TR001430). - Β© 2020