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Current HIV Research

Editor-in-Chief

ISSN (Print): 1570-162X
ISSN (Online): 1873-4251

Research Article

Sex and Gender Differences in Rilpivirine based ART - Data from the HIVCENTER Frankfurt

Author(s): G. Schüttfort*, K. Philipp, P. de Leuw , E. Herrmann , G. Kann , P. Khaykin, C. Stephan, T. Wolf and A. Haberl

Volume 17, Issue 5, 2019

Page: [368 - 374] Pages: 7

DOI: 10.2174/1570162X17666191104112557

Price: $65

Abstract

Objective: While Rilpivirine has shown high overall response rates in treatment-naïve patients without sex and gender specific differences in clinical trials, Sex and gender specific data in treatment experienced patients receiving rilpivirine are still limited. We conducted a 48 week efficacy and safety analysis in naïve and treatment experienced men and women using retrospective data from the HIVCENTER Frankfurt.

Materials and Methods: In this retrospective observational study data of all patients who received a rilpivirine based regimen at the HIVCENTER between March 2011 and December 2015 were analyzed. Primary endpoint was the proportion of patients with any discontinuation until week 48. Virologic response rates (FDA snapshot analysis; HIV-1 RNA <50 copies/mL) were assessed at week 48.

Results: 194 patients (34% female) were included in the analysis. 74% were treatment-experienced and 26% naïve, respectively. Discontinuations were observed in 31 (15.9%) patients. Regarding sex differences, the proportion of discontinuations was significantly higher in women than in men (24.2% vs. 11.7%; p=0.024; ODDS-Ratio = 2.41; CI 1.12 – 5.18). Virologic failure occurred in 8 PLWHIV (4.1%).

Conclusion: While virologic overall response rates to rilpivirine based ART were high for both treatment-experienced and -naïve patients the proportion of discontinuations was significantly higher in women (24.2% vs. 11.7%; p = 0.024; ODDS-Ratio = 2.41; CI 1.12 – 5.18). Although the total number of patients with virologic failure was low (4.1%), the higher rate of ART discontinuations in female patients receiving RPV require close monitoring in the first months of treatment addressing special needs of women living with HIV.

Keywords: HIV, NNRTI, rilpivirine, gender, ART, immunodeficiency, virus.

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[1]
Cohen C, Molina J-M, Cahn P, et al. Pooled week 48 efficacy and safety results from ECHO and THRIVE, two double-blind, randomized, phase III trials comparing TMC278 versus Efavirenz in treatment-naïve, HIV-1-infcted patients. 18th International AIDS Conference. Vienna, Austria. 2010.
[2]
Pozniak AL, Morales-Ramirez J, Katabira E, et al. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS 2010; 24(1): 55-65.
[http://dx.doi.org/10.1097/QAD.0b013e32833032ed] [PMID: 19926964]
[3]
Wilkin A, Pozniak AL, Morales-Ramirez J, et al. TMC278 shows favorable tolerability and non-inferior efficacy compared to Efavirenz over 192 weeks in HIV-1 infected treatment-naïve patients. 19th Annual Canadian Conference on HIV/AIDS Research. Saskatoon, Canada, 2010.
[4]
Hodder S, Arasteh K, De Wet J, et al. Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. HIV Med 2012; 13(7): 406-15.
[http://dx.doi.org/10.1111/j.1468-1293.2012.00991.x] [PMID: 22416849]
[5]
EDURANT: Highlights of prescribing information. [Accessed on: 23 August 2018]; Available from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/EDURANT-pi.pdf
[6]
Complera™ (emtricitabine/rilpivirine/tenofovir disoxoproxil fumarate) tablets prescribing information. [Accessed on: 16 October 2019]: Available form:www.gilead.com/pdf/complera_pi.pdf
[7]
European AIDS Clinical Society Guidelines Version 9.0. October 2017, p. 36.
[8]
Leith J, Piliero P, Storfer S, Mayers D, Hinzmann R. Appropriate use of nevirapine for long-term therapy. J Infect Dis 2005; 192(3): 545-6.
[http://dx.doi.org/10.1086/431606] [PMID: 15995971]
[9]
Baylor MS, Johann-Liang R. Hepatotoxicity associated with nevirapine use. J Acquir Immune Defic Syndr 2004; 35(5): 538-9.
[http://dx.doi.org/10.1097/00126334-200404150-00014] [PMID: 15021321]
[10]
Smith CJ, Sabin CA, Youle MS, et al. Response to efavirenz-containing regimens in previously antiretroviral-naive HIV-positive patients: the role of gender. J Acquir Immune Defic Syndr 2007; 46(1): 62-7.
[http://dx.doi.org/10.1097/QAI.0b013e31813e5e20] [PMID: 17667341]
[11]
Viramune® (nevirapine) prescribing information 2018 August. [Accessed on: 16 October 2019]; Available at: https://bidocs.boerhinger-ingelheim.com/BIWebAccess/ View Servlet.ser?docBase=renetntfolderPath=/Prescribing+ Information/ PIs/Viramune/Viramune.pdf
[12]
Medical Dictionary for Regulatory Activities Terminology (Med- DRA) version 16.0. [Accessed on: 17 October 2019]; Available at: https://www.meddra.org/
[13]
Gantner P, Cuzin L, Allavena C, et al. Efficacy and safety of dolutegravir and rilpivirine dual therapy as a simplification strategy: a cohort study. HIV Med 2017; 18(9): 704-8.
[http://dx.doi.org/10.1111/hiv.12506] [PMID: 28444816]
[14]
Cohen C, Wohl D, Arribas JR, et al. Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults. AIDS 2014; 28(7): 989-97.
[http://dx.doi.org/10.1097/QAD.0000000000000169] [PMID: 24508782]
[15]
Bagella P, De Socio GV, Ricci E, et al. Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project. Infect Drug Resist 2018; 11: 615-23.
[http://dx.doi.org/10.2147/IDR.S152090] [PMID: 29731650]
[16]
Hodder S, Jayaweera D, Mrus J, Ryan R, Witek J. Efficacy and safety outcomes among treatment-experienced women and men treated with etravirine in gender, race and clinical experience. AIDS Res Hum Retroviruses 2012; 28(6): 544-51.
[http://dx.doi.org/10.1089/aid.2011.0118] [PMID: 22206504]
[17]
d’Arminio Monforte A, Lepri AC, Rezza G, et al. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naïve patients. I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients. AIDS 2000; 14(5): 499-507.
[http://dx.doi.org/10.1097/00002030-200003310-00005] [PMID: 10780712]
[18]
Squires KE, Johnson M, Yang R, et al. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother 2011; 66(2): 363-70.
[http://dx.doi.org/10.1093/jac/dkq457] [PMID: 21148235]
[19]
Mills AM, Antinori A, Clotet B, et al. Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks. HIV Med 2013; 14(7): 391-400.
[http://dx.doi.org/10.1111/hiv.12012] [PMID: 23298380]
[20]
Currier J, Averitt Bridge D, Hagins D, et al. Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Ann Intern Med 2010; 153(6): 349-57.
[http://dx.doi.org/10.7326/0003-4819-153-6-201009210-00002] [PMID: 20855799]
[21]
von Hentig N, Carlebach A, Gute P, et al. A comparison of the steady-state pharmacokinetics of nevirapine in men, nonpregnant women and women in late pregnancy. Br J Clin Pharmacol 2006; 62(5): 552-9.
[http://dx.doi.org/10.1111/j.1365-2125.2006.02664.x] [PMID: 17061962]
[22]
Haas DW, Bartlett JA, Andersen JW, et al. Pharmacogenetics of nevirapine-associated hepatotoxicity: an Adult AIDS Clinical Trials Group collaboration. Clin Infect Dis 2006; 43(6): 783-6.
[http://dx.doi.org/10.1086/507097] [PMID: 16912957]
[23]
Sculier D, Gayet-Ageron A, Battegay M, et al. Rilpivirine use in the Swiss HIV cohort study: a prospective cohort study. BMC Infect Dis 2017; 17(1): 476.
[http://dx.doi.org/10.1186/s12879-017-2579-2] [PMID: 28683720]
[24]
Lundgren JD, Babiker AG, Gordin F, et al. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med 2015; 373(9): 795-807.
[http://dx.doi.org/10.1056/NEJMoa1506816] [PMID: 26192873]
[25]
Lundgren JD, Babiker A, El-Sadr W, et al. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis 2008; 197(8): 1145-55.
[http://dx.doi.org/10.1086/529523] [PMID: 18476293]

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