Around half of the global adult HIV-positive population are women, yet historically women have been under-represented in clinical studies of antiretroviral therapy (ART) and there has been minimal exploration of gender-specific factors related to the response to and appropriateness of treatment choices in women living with HIV (WLWH). There are several key issues pertaining to the cascade of HIV care that make it important to differentiate WLWH from men living with HIV. Factors that are gender specific may impact on the status of WLWH, affecting access to diagnosis and treatment, optimal clinical management, ART outcomes, retention in care, and the overall long-term wellbeing of WLWH. In this review, we discuss the results of recently reported women-only clinical trials and highlight the key unmet needs of WLWH as they pertain to the cascade of HIV care across World Health Organization European Region countries. As significant knowledge gaps remain, the review identifies key areas where further research is required, in order to support improved management of WLWH and guide informed clinical decision-making, including addressing psychosocial factors as part of comprehensive care.
Purpose of studyIrregular FUP/ADH were associated with virologic failure [1] leading to an increase in mortality [2]. SEAD was a multidimensional intervention project, designed from the patient's perspective, to specifically attend patients with poor FUP/ ADH in an HIV/AIDS outpatient clinic.MethodsFrom Jan 2006 to May 2010, patients with poor FUP/ADH were offered SEAD inclusion, all were evaluated by a nurse or a psychologist (adherence collaborators) who assessed all the reasons and barriers precluding a correct FUP/ADH. For each identified problem, different interventions were planned, using our own resources or coordinating others. Follow-up was censored in Nov 2011. Univariate and multivariable models were performed to evaluate the influence of SEAD intervention in virological suppression (HIV-ARN <1.7 log copies/mL) at the end of follow-up.Summary of resultsOverall, 242 patients were assessed: mean age 46 years, 78% men, 69% IDU, 51% AIDS, baseline ADH >90% 29.3%; median CD4 cell count 333 [164–536] cells/mL and HIV-RNA <1.57 45%. Patients were admitted in SEAD due to poor ADH 15%, FUP problems 21%, both FUP/ADH 53% and to prevent poor ADH or FUP 11%. Main reasons driving poor FUP/ADH were severe biopsychosocial problems 26%, severe drug and/or alcohol abuse 23%, logistic problems 21.3%, other psychiatric disorders 14%, oversights 10%, unknown 3% and antiretroviral intolerance 2%. Cocaine/heroin and alcohol abuse was reported by 33% and 16%. Only 57% of patients received >50% of planned interventions. After a median follow-up of 3.9 (3.27–4.43) years 218 patients received 8 (3–12) interventions/year, 95% evaluation interview and 30% psychological counselling (3 sessions/year [2–5]). Virological suppression was achieved by 67% of patients. In logistic regression analysis an intervention higher than 50% of planned HR 0.220 [IC 95% (0.112–0.44)] and receiving psychological counselling HR 0.44 [IC 95% (0.20–0.97)] were independent predictors of virological suppression whereas alcohol 3.11 (95% CI 1.24–7.80) and severe biopsychosocial problems HR 2.39 (95% CI 1.134–5.040) were associated with worse virological response, after adjusting for age, alcohol or cocaine abuse, degree of adherence, baseline virological suppression, median follow–up, intravenous acquisition of HIV, and family support.ConclusionsGeneral and psychological SEAD intervention resulted in higher virological suppression in patients with severe follow-up and adherence barriers.
Purpose of the study: DRV/r mx is proposed as a therapeutic option for patients with NNRTI toxicity. We aimed to evaluate the impact of switching to DRV/r mx in kidney function and lipid profile. Methods: From March 2009 to June 2012 we conducted an observational, retrospective multicenter study evaluating patients switching to DRV/r mx. Kidney function and lipid levels were measured at baseline and at 48 weeks of DRV/r mx. Renal function was estimated by MDRD GFR. Comparative analyzes were performed using Student's t test for paired samples. Summary of results: We identified 147 patients: women 30.6%, age 49±7yr, 45% IDU, 27.9% heterosexuals, AIDS 41.5%, Caucasian 58.5%, HCV-coinfected 48%, baseline HIV-RNA <1.7 log 93.2%, nadir and baseline CD4 count 180±150 and 663±297 cells/mm3, length of antiretroviral therapy 12.83±4.6 years and of HIV-RNA <1.7 62±43 months. The rate of HIV-RNA <1.7 at week 48 were 78.9% ITT; 92.6% OTT. Improvement was observed in kidney function after 48 w of DRV/r mx, mean 0 w vs 48 w MDRD (84.43±22.32 vs. 87.88±23.24; p=0.001). Subgroup analysis demonstrated significantly higher increases in MDRD in patients with a prior tenofovir-based regimen (TDF), 83.14±21.86 and 48 w 88.97±21.23; p=0.000, and those with a protease inhibitor plus TDF-based regimen (mean 0 w vs 48 w MDRD 80.66±22.53 87.09±23.37; p=0.002). Lipid profile improved significantly in terms of reduction in total cholesterol (mean 0 w col: 192.47±42.44 vs mean 48 w col 170.48±70.79; p=0.013) with an improvement in the ratio total cholesterol/ HDL (0 w 4.46±1.62 vs 48 w ratio 3.97±2.12; p=0.000). There were no significant changes in lipid profile in subgroup analysis according to previous antiretroviral treatment change. Conclusions: Patients switching to DRV/r monotherapy showed significant improvement in kidney function and lipid profile at 48 w, both implied on cardiovascular risk
Purpose of the study: To evaluate the economic impact of a swiching strategy to DRV/r mx in clinical practice using Spanish prices. Methods: Multicenter retrospective study of four tertiary hospitals in Spain. The analysis includes 147 patients switching to DRV/r mx mainly due to toxicity or simplification from March 2009 to June 2011. The Spanish costs (ex-factory price+VAT) per patient with HIV RNA<50 copies/ml were calculated, accounting for additional/ switch antiretroviral taken after initial treatment failure and management of adverse events. Cost of adverse events were based on a Spanish publication [1] (updated by the inflation rate until april 2012) The horizon of the analysis was of 48 weeks. Summary of results: Baseline characteristics were: women (30.6%), median age (49 yr), IDU (45%), AIDS stage (32%), HCV coinfected (48%, 40% with advanced fibrosis), length of HIV-RNA<1.7 before DRV/rtv mtx 67.6. Most frequent reasons for switching to DRVr mx were toxicity (62.6%) and simplification (23.8%). If a hospital with 600 patients in ART treatment, switched from 10% to 20% of its patients to DRV/r mx, there is a potential to save up to 448,000€/year. Conclusions: Switching to DRV/r mx is a cost-effective strategy that allows more patients to be treated for a fixed budget. Higher cost saving is expected when toxicity is the reason for switching. 48 Weeks Cost-Efficacy analysis: Simplification strategy to DRV/r monotherapy Hospital Budget Impact Analysis: assuming that 10%–20% of 600 patients in ARV treatment simplifies to DRV/r monotherap
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