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

2019 ◽  
Vol 17 (5) ◽  
pp. 368-374
Author(s):  
G. Schüttfort ◽  
K. Philipp ◽  
P. de Leuw ◽  
E. Herrmann ◽  
G. Kann ◽  
...  

Objectives: 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%). Conclusions: 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.

2017 ◽  
Vol 62 (2) ◽  
Author(s):  
Preethi Krishnan ◽  
Gretja Schnell ◽  
Rakesh Tripathi ◽  
Jill Beyer ◽  
Thomas Reisch ◽  
...  

ABSTRACT Glecaprevir and pibrentasvir are hepatitis C virus (HCV) pangenotypic inhibitors targeting NS3/4A protease and NS5A, respectively. This once-daily, fixed-dose combination regimen demonstrated high sustained virologic response 12 weeks postdosing (SVR12) rates in CERTAIN-1 and CERTAIN-2 studies in Japanese HCV-infected patients, with a low virologic failure rate (1.2%). There were no virologic failures among direct-acting antiviral (DAA)-treatment-naive genotype 1a (GT1a) (n = 4)-, GT1b (n = 128)-, and GT2 (n = 97)-infected noncirrhotic patients treated for 8 weeks or among GT1b (n = 38)- or GT2 (n = 20)-infected patients with compensated cirrhosis treated for 12 weeks. Two of 33 DAA-experienced and 2 of 12 GT3-infected patients treated for 12 weeks experienced virologic failure. Pooled resistance analysis, grouped by HCV subtype, treatment duration, prior treatment experience, and cirrhosis status, was conducted. Among DAA-naive GT1b-infected patients, the baseline prevalence of NS3-D168E was 1.2%, that of NS5A-L31M was 3.6%, and that of NS5A-Y93H was 17.6%. Baseline polymorphisms in NS3 or NS5A were less prevalent in GT2, with the exception of the common L/M31 polymorphism in NS5A. Among DAA-experienced GT1b-infected patients (30/32 daclatasvir plus asunaprevir-experienced patients), the baseline prevalence of NS3-D168E/T/V was 48.4%, that of NS5A-L31F/I/M/V was 81.3%, that of the NS5A P32deletion was 6.3%, and that of NS5A-Y93H was 59.4%. Common baseline polymorphisms in NS3 and/or NS5A had no impact on treatment outcomes in GT1- and GT2-infected patients; the impact on GT3-infected patients could not be assessed due to the enrollment of patients infected with diverse subtypes and the limited number of patients. The glecaprevir-pibrentasvir combination regimen allows a simplified treatment option without the need for HCV subtyping or baseline resistance testing for DAA-naive GT1- or GT2-infected patients. (The CERTAIN-1 and CERTAIN-2 studies have been registered at ClinicalTrials.gov under identifiers NCT02707952 and NCT02723084, respectively.)


2019 ◽  
pp. 31-43 ◽  
Author(s):  
Daphne S. van Casteren ◽  
Emile G. M. Couturier ◽  
Antoinette Maassen van den Brink

2020 ◽  
Vol 21 (4) ◽  
pp. 1477
Author(s):  
Mauro Vaccarezza ◽  
Veronica Papa ◽  
Daniela Milani ◽  
Arianna Gonelli ◽  
Paola Secchiero ◽  
...  

In the last two decades, new insights have been gained regarding sex/gender-related differences in cardiovascular disease (CVD). CVD represents the leading cause of death worldwide in both men and women, accounting for at least one-third of all deaths in women and half of deaths in women over 50 years in developing countries. Important sex-related differences in prevalence, presentation, management, and outcomes of different CVDs have been recently discovered, demonstrating sex/gender-specific pathophysiologic features in the presentation and prognosis of CVD in men and women. A large amount of evidence has highlighted the role of sex hormones in protecting women from CVDs, providing an advantage over men that is lost when women reach the menopause stage. This hormonal-dependent shift of sex-related CVD risk consequently affects the overall CVD epidemiology, particularly in light of the increasing trend of population aging. The benefits of physical activity have been recognized for a long time as a powerful preventive approach for both CVD prevention and aging-related morbidity control. Exercise training is indeed a potent physiological stimulus, which reduces primary and secondary cardiovascular events. However, the underlying mechanisms of these positive effects, including from a sex/gender perspective, still need to be fully elucidated. The aim of this work is to provide a review of the evidence linking sex/gender-related differences in CVD, including sex/gender-specific molecular mediators, to explore whether sex- and gender-tailored physical activity may be used as an effective tool to prevent CVD and improve clinical outcomes in women.


2019 ◽  
Vol 28 (12) ◽  
pp. 1755-1761
Author(s):  
Robert Casanova ◽  
Virginia Miller ◽  
Jongpil Cheon ◽  
Linda Gilmore ◽  
Rebecca Barron ◽  
...  

2020 ◽  
Vol 10 (7) ◽  
pp. 421 ◽  
Author(s):  
Pamela Tozzo ◽  
Silvia Zullo ◽  
Luciana Caenazzo

Gender-specific medicine is a discipline that studies the influence of sex and gender on physiology, pathophysiology, and diseases. One example in light of how a genetic-based disease among other diseases, that impact on sex, can be represented by the risk of developing dementia or Alzheimer’s disease. The question that comes into focus is whether gene-editing can represent a new line of investigation to be explored in the development of personalized, gender-specific medicine that guarantees gender equity in health policies. This article aims to discuss the relevance of adopting a gender-specific focus on gene-editing research, considered as a way of contributing to the advance of medicine’s understanding, treatment, and prevention of dementia, particularly Alzheimer’s disease. The development or improvement of cures could take advantage of the knowledge of the gender diversity in order to ascertain and develop differential interventions also at the genetic level between women and men, and this deserves special attention and deep ethical reflection.


2014 ◽  
Vol 174 (8) ◽  
pp. 1348 ◽  
Author(s):  
C. Noel Bairey Merz ◽  
Vera Regitz-Zagrosek

ESMO Open ◽  
2020 ◽  
Vol 5 (Suppl 4) ◽  
pp. e000796
Author(s):  
Nuria Mederos ◽  
Alex Friedlaender ◽  
Solange Peters ◽  
Alfredo Addeo

Lung cancer remains the leading cause of cancer-related deaths worldwide in women and men. In incidence, lung cancer ranks second, surpassed by breast cancer in women and prostate cancer in men. However, the historical differences in mortality and incidence rate between both sexes have changed in the last years. In the last decades, we have also witnessed an increased number of lung cancer in female never-smokers. These disparities have grown our interest in studying the impact of the gender and sex in the presentation of lung cancer. The aetiology is yet to be fully elucidated, but the data are clear so far: there is a growing divide between lung cancer presentation in women and men that will change our management and study of lung cancer. This article aims to review the sex and gender differences in lung cancer.


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