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.
