Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents.

BACKGROUND: Rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor drug, could be a favourable drug for maintenance therapy in HIV-infected adolescents because it has few long-term side effects. However, data among adolescents switching from efavirenz (EFV) to RPV are limited. This study investigated the pharmacokinetics (PK), safety and efficacy of RPV in virologically suppressed HIV-1-infected adolescents after switching from EFV. METHODS: Adolescents aged 12-18 years on EFV-based antiretroviral therapy (ART) were switched from EFV to RPV (25 mg, once daily). Intensive 24-h blood samplings at 0 (pre-dose), 1, 2, 4, 5, 6, 9, 12 and 24 h were performed 4 weeks after switching. PK parameters were calculated using a non-compartmental method and compared with published data from the PAINT and pooled ECHO/THRIVE substudies. HIV RNA level was measured at weeks 12 and 24. Biochemical profiles were measured at baseline and week 24. RESULTS: From January to June 2016, 20 adolescents (12 male) were enrolled. Median (IQR) age was 16 (15-17) years and weight was 49 (42-59) kg. Mean (sd) AUC24 h, C24 h and Cmax of RPV were 2,041 (745) ng•h/ml, 69 (29) ng/ml and 143 (65) ng/ml, respectively. Median (IQR) Tmax was 5 (2-9) h. Four adolescents had C24 h <40 ng/ml. All PK parameters were comparable with published data. All adolescents remained virologically suppressed at week 24. Significant decreases in fasting total cholesterol, triglyceride and low-density lipoprotein were observed (P-value <0.05). CONCLUSIONS: Virologically suppressed HIV-infected adolescents had adequate RPV exposure and remained virologically suppressed after switching from EFV. RPV can be used as long-term maintenance ART in HIV-infected adolescents.

Low-level genital HIV shedding in Thai HIV-infected women with suppressed plasma viral load after menopause: a longitudinal study.

OBJECTIVES: First, to evaluate the longitudinal changes of HIV RNA in genital secretions in HIV-positive women with plasma HIV RNA <50 copies/mL before and after the onset of menopause. Second, to assess inflammatory markers and prevalence of comorbidities after the onset of menopause. METHODS: This was a prospective observational study with two time points. HIV RNA in genital secretions (GVL) was measured in 15 HIV-positive menopausal women (second time point). Results were compared to earlier available data for GVL from the same participant before the onset of menopause (first time point). RESULTS: Median age at the first time point was 42 years, and 52 years at the second time point. Median time since the onset of menopause was 2 years and 33% of women were sexually active. Eighty per cent had at least one comorbidity. The GVL before menopause was >50 copies/mL in 27% of the participants, and in 40% after menopause. The GVL was <1000 copies/mL in all but one measurement. There was no significant difference between the two time points (P=0.687). Intermediate vaginal flora or bacterial vaginosis was found in 73% of participants during the second time point. CONCLUSIONS: There was a high prevalence of low-level GVL shedding before and after menopause. This needs further investigation, especially in relation to the vaginal microbiome and the complex interactions between micro-organisms. HIV-infected women in menopause do not seem to present a major public health risk for HIV transmission. Nevertheless, safe sex should be discussed with all, regardless of age. The high prevalence of non-communicable diseases after menopause requires special attention and comprehensive care.