Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials.

OBJECTIVES: The single-tablet regimen rilpivirine, emtricitabine and tenofovir alafenamide (RPV/FTC/TAF) for treatment of HIV-1-infected adults was approved based on bioequivalence. We assessed the clinical efficacy, safety and tolerability of switching to RPV/FTC/TAF from either RPV/FTC/tenofovir disoproxil fumarate (TDF) or efavirenz (EFV)/FTC/TDF. METHODS: We conducted two distinct randomized, double-blind, active-controlled, noninferiority trials in participants taking RPV/FTC/TDF (Study 1216) and EFV/FTC/TDF (Study 1160). Each study randomized virologically suppressed (HIV-1 RNA < 50 copies/mL) adults (1:1) to switch to RPV/FTC/TAF or continue their current regimen for 96 weeks. We evaluated efficacy as the proportion with HIV-1 RNA < 50 copies/mL using the Food and Drug Administration snapshot algorithm and prespecified bone and renal endpoints at week 96. RESULTS: We randomized and treated 630 participants in Study 1216 (RPV/FTC/TAF, n = 316; RPV/FTC/TDF, n = 314) and 875 in Study 1160 (RPV/FTC/TAF, n = 438; EFV/FTC/TDF, n = 437). In both studies, the efficacy of switching to RPV/FTC/TAF was noninferior to that of continuing baseline therapy at week 96, with respective percentages of patients with HIV RNA < 50 copies/mL being 89.2% versus 88.5% in Study 1216 [difference 0.7%; 95% confidence interval (CI) -4.3 to +5.8%] and 85.2% versus 85.1% in Study 1160 (difference 0%; 95% CI -4.8 to +4.8%). No participant on RPV/FTC/TAF developed treatment-emergent resistance versus two on EFV/FTC/TDF and one on RPV/FTC/TDF. Compared with continuing baseline therapy, significant improvements in bone mineral density and renal tubular markers were observed in the RPV/FTC/TAF groups (P < 0.001). CONCLUSIONS: Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF was safe and effective and improved bone mineral density and renal biomarkers up to 96 weeks with no cases of treatment-emergent resistance.

CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001.

SETTING: Port-au-Prince, Haiti. OBJECTIVE: To determine long-term effects of early vs. delayed initiation of antiretroviral therapy (ART) on immune recovery and tuberculosis (TB) risk in human immunodeficiency virus (HIV) infected individuals. DESIGN: Open-label randomized controlled trial of immediate ART in HIV-infected adults with CD4 counts between 200 and 350 cells/mm(3) vs. deferring ART until the CD4 count was <200 cells/mm(3). The primary comparisons were CD4 counts over time and risk for incident TB, with 5 years of follow-up. RESULTS: A total of 816 participants were enrolled, with 408 in each treatment arm. The early treatment group started ART within 2 weeks, while the deferred treatment group started ART a median of 1.3 years after enrollment. After 5 years, the mean CD4 count in the early treatment group was significantly higher than in the deferred treatment group (496 cells/mm(3), 95% confidence interval [CI] 477-515 vs. 373 cells/mm(3), 95%CI 357-389; P < 0.0001). TB risk was higher in the deferred treatment group (unadjusted HR 2.41, 95%CI 1.56-3.74; P < 0.0001) and strongly correlated with lower CD4 counts in time-dependent multivariate analysis. CONCLUSION: Delays in ART initiation for HIV-infected adults with CD4 counts of 200-350 cells/mm(3) can result in long-term immune dysfunction and persistent increased risk for TB.

Stability of formate species on beta-Ga2O3.

Gallia (gallium oxide) has been proved to enhance the performance of metal catalysts in a variety of catalytic reactions involving methanol, CO and H(2). The presence of formate species as key intermediates in some of these reactions has been reported, although their role is still a matter of debate. In this work, a combined theoretical and experimental approach has been carried out in order to characterize the formation of such formate species over the gallium oxide surface. Infrared spectroscopy experiments of CO adsorption over H(2) (or D(2)) pretreated beta-Ga(2)O(3) revealed the formation of several formate species. The beta-Ga(2)O(3) (100) surface was modelled by means of periodic DFT calculations. The stability of said species and their vibrational mode assignments are discussed together with the formate interconversion barriers. A possible mechanism is proposed based on the experimental and theoretical results: first CO inserts into surface (monocoordinate) hydroxyl groups leading to monocoordinate formate; this species might evolve to the thermodynamically most stable dicoordinate formate, or might transfer hydrogen to the surface oxidizing to CO(2) creating an oxygen vacancy and a hydride group. The barrier for the first step, CO insertion, is calculated to be significantly higher than that of the monocoordinate formate conversion steps. Monocoordinate formates are thus short-lived intermediates playing a key role in the CO oxidation reaction, while bidentate formates are mainly spectators.

A new quality-of-life measure for men experiencing involuntary childlessness.

BACKGROUND: Infertility may considerably reduce quality-of-life. Many of the existing generic quality-of-life measures, which often focus on physical impairments, do not represent the specific complaints of infertile patients. In this article, we report on the development and validation of the TLMK (Tübinger Lebensqualitätsfragebogen für Männer mit Kinderwunsch), an instrument for measuring quality-of-life in male patients with involuntary childlessness. METHODS: The first version of the questionnaire, which consisted of 91 items, was administered to 275 men who attended andrology and gynaecology clinics for fertility evaluations. After the questionnaires were scored, item analysis and reduction, principal component analysis and internal consistency analyses were conducted. RESULTS: The final version of the TLMK consists of 35 items in four scales and provides an internally consistent quality-of-life profile for men experiencing involuntary childlessness. Convergent and discriminant validity was supported through the correlation of the TLMK scales with established questionnaires on life satisfaction (FLZ) and partnership (PFB). CONCLUSION: The TLMK provides information about the quality-of-life in men experiencing involuntary childlessness and was found to be easy to administer and acceptable to patients. It may be used to assess patients' baseline and ongoing quality-of-life during fertility treatment and as an outcome variable in the evaluation of integrated psychological counselling.

Litigation risks for infusion specialists. Understanding the issues.

The legal aspects of caring for patients and the fear of disciplinary actions or malpractice suits understandably are matters of great concern for infusion specialists. This article is intended to be a broad overview of some of the legal causes of action that may arise through the rendering of professional nursing care, as well as an introduction to patients' rights to self-determination, informed consent, and informed refusal as a special area of litigation risk for the infusion specialist.

Differential utility of three indexes of risky drinking for predicting alcohol problems in college students.

This study evaluated the relationship between alcohol-related problems and 3 indexes of risky drinking in college student drinkers: number of drinks consumed per week, frequency of binge drinking, and estimated blood alcohol levels (BALs). Use of 2 independent samples (N1 = 204, N2 = 181) allowed a cross-validation of obtained associations. Results indicated that neither binge drinking frequency nor BAL were more highly related to alcohol-related problems than was weekly drinking. Furthermore, BAL did not provide unique explanatory power in accounting for alcohol-related problems; mixed results were obtained regarding the relationship of binge drinking estimates with problems.

Errors in postcode to enumeration district mapping and their effect on small area analyses of health data.

BACKGROUND: Health research often seeks to associate individuals to their socio-economic circumstances by linking an individual's postcode to their Census enumeration district (ED). As part of a study into health visitor resource allocation the objective here is to quantify the errors that arise in attaching ED level deprivation scores to records and counts of records by ED when records are matched to EDs via their postcodes rather than their exact address. METHODS: The result of routine matching of postcodes to EDs was compared with the more accurate method of matching addresses to EDs. Townsend scores were then attributed to records according to the two different methods and the results compared. A sample of 4013 births registered in Sheffield in 1996 was used. RESULTS: The comparative work showed that the mismatching of individual addresses arising from matching postcodes to EDs was 16.4 per cent. (The 95 per cent confidence interval is 15.1-17.7 per cent.) Over one-third of mismatched records (about 6 per cent of the total records) were found to have Townsend scores greater than +/- 2 compared with the score obtained through the more accurate process of address matching. CONCLUSIONS: The evidence of the study is that it is important to recognize there are errors inherent in matching individual addresses to EDs via the address postcode. For problems involving resource allocation and for research into relationships between health outcomes or service uptake and deprivation it may be necessary to seek to quantify the level of error introduced through using postcode to ED matching.