Suchergebnisse

The rilpivirine/tenofovir/emtricitabine fixed‐dose combination (RTE FDC) (Complera, Eviplera) is a potent convenient, well‐tolerated antiretroviral regimen. While it is officially indicated only for treatment‐naïve patients, it is attractive for use as a regimen to switch to for patients experiencing toxicities or side effects, or who simply want a regimen with fewer pills. This is a retrospective review of patients who switched to RTE FDC from other antiretroviral regimens in a large HIV specialty private practice. 111 patients were identified who switched to RFE FDC from other regimens who had at least six months follow‐up (median 8 months). 44 were previously taking the efavirenz/tenofovir/emtricitabine fixed‐dose combination (ETE FDC) (Atripla), 24 nevirapine with NRTIs, 16 protease‐based regimens, 10 on raltegravir with NRTIs, and 17 on various other regimens. Patients had been on therapy for a median of 6.25 years. 86 patients had an HIV PCR<20 at the time of switch, 21 had low grade positive PCRs (<400) and 4 patients switched after an interruption in therapy with viral loads of 5880–88,000. Median CD4 cell count at the time of switch was 663 (range 142–2244). 14 patients had previously failed treatment and had resistance mutations; 4 with M184V, 5 with K103N, but none with rilpivirine nor tenofovir‐specific resistance mutations. One patient discontinued RFE FDC after a single PCR of 520; all others have remained undetectable at most recent visit (91<20, 19<400). Median CD4 cell count on the most recent visit is 656. Creatinine (first visit after switch) increased by a mean of 0.04 mg/dl (0.05 in those switching from a non‐tenofovir containing regimen, 0.04 in those switching from a tenofovir containing regimen). There was no significant change in LFTs. Mean cholesterol decreased by 18 mg/dl (23 in those switching from ETE FDC, 12 from protease inhibitors, 27 from nevirapine and 2 from raltegravir). Six patients co‐infected with hepatitis B remain with an undetectable hepatitis B PCR. Patients were asked to complete a questionnaire, rating their new and old regimens on a scale of one (bad) to ten (good) (Table). For appropriate patients wishing to switch their treatment regimen for toxicity, side‐effects or even just pill burden, RTE FDC is an efficacious, well tolerated, convenient alternative.









RTE FDC
Old regimen




No side effects
9.6
8.3


Ease of administration
9.5
8.6


No problem with food requirement
8.9




8.7

Raltegravir is a potent, extremely well tolerated antiretroviral, and is a component of a preferred regimen in many treatment guidelines. Despite its indication as a twice‐daily (400 mg BID) drug, there has always been interest in once‐daily (800 mg QD) use of raltegravir (RTG). The "QD Merck", however, showed a higher rate of virologic failure in subjects taking RTG QD with Truvada as opposed to twice daily (BID). This trial, however, was in treatment‐naïve patients, and the majority of virologic failures were in those with high viral loads. In patients already virologically suppressed on antiretroviral therapy a regimen including QD raltegravir is more convenient, and may still be effective for virologic suppression. This is a retrospective review of patients in a large HIV‐specialty private practice. 105 patients were identified who have been on QD RTG for at least 6 months (median 23, range 6–55 months). 70 patients were also on Truvada, 10 on Epzicom, 7 on atazanavir, and 18 on more than two additional drugs. All patients had undetectable (<200) viral loads when starting QD RTG, and had been on other treatment for a median of 117 months (range 13–276). Median CD4 count on starting QD RTG was 606 (range 154–1358). 50 patients had been previously on BID RTG for a median of 12 months; 55 started directly on a QD RTG regimen. 32 patients had a history of previous treatment failure/resistance, although mostly to drugs not included in the current regimen. All patients remain undetectable (PCR<200 copies/ml) with no treatment failures seen. In clinically stable patients already suppressed on antiretroviral therapy, including BID RTG regimens, a switch to QD RTG appears to be effective at maintaining long‐term virologic control. QD dosing is certainly more convenient, and may improve adherence.

Edited by W.W. Tompkins. ; Caption title. ; No more published. cf. Union list of serials. ; Mode of access: Internet.

Politicians frequently use political speech to foster hostility toward immigrants, a strategy that shapes political preferences and behavior and feeds the success of the populist right. Whether political speech can be used to foster tolerance of immigrants, however, remains unexplored. We identify three mechanisms by which political speech could increase tolerance: (1) stressing in-group conceptions that highlight commonalities with immigrants; (2) emphasizing inclusiveness as an in-group norm; and (3) providing information that counters anti-immigrant stereotypes. Using quotes from US politicians in two survey experiments, we find that pro-immigrant speech that stresses inclusive norms or counters negative stereotypes about immigrants leads to more tolerant attitudes (but not behavior) toward immigrants. These effects are small and detectable only in large samples.

Purpose of the studyTRANxITION compared the efficacy and safety of switching virologically suppressed patients from NVP IR (200 mg BID) to NVP XR (400 mg QD) and demonstrated the non‐inferior efficacy of NVP XR in virologically suppressed patients. Here, post‐48‐week safety and efficacy results of patients initially randomized to NVP IR and allowed to switch to NVP XR after 48 weeks, were compared to patients on NVP XR throughout the study.MethodsTRANxITION was an open‐label, parallel‐group, non‐inferiority clinical trial where adult HIV‐1 patients receiving NVP IR plus a fixed‐dose NRTI combination of lamivudine (3TC)/abacavir (ABC), tenofovir (TDF)/emtricitabine (FTC) or 3TC/zidovudine (ZDV), with undetectable viral loads (VL) were initially randomized (2:1) to NVP XR or NVP IR. After week 48, patients initially randomized to NVP IR were allowed to switch to NVP XR. Primary endpoint was continued virologic suppression (VL<50 copies/mL) at week 24. Secondary endpoints included long‐term follow‐up at 48 and 144 weeks.Summary of resultsAt week 48, proportions of patients with virologic response (LLOQ = 50 copies/mL TaqMan, FAS) were 88.5% (131/148) NVP IR BID arm, and 88.8% (262/295) NVP XR QD, with an observed difference of 0.3% (95% CI −6.1, 6.7). Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 3 and 4 events were similar for the NVP XR and NVP IR groups at week 48, 6.4% (19/295) vs. 6.1% (9/148) respectively, although serious AEs were slightly higher in the NVP XR group (10.2%, 30/295, vs. 8.1%, 12/148 for the NVP‐IR group). After week 48, all but 13 patients in the NVP IR arm switched to NVP XR. At week 144, proportions of patients with virologic response were 115/121 (95.0%, patients switching from IR to XR after week 48 [IRpost48XR]), and 238/250 (95.2%, patients on XR throughout [XRpost48]). DAIDS grade 3 and 4 events were similar for both post‐week‐48 XR groups at week 144, with (10/130, 7.7%, [IRpost48XR] vs. (31/276, 11.2% [XRpost48]), while serious AEs were higher in the XRpost48 patients (54/276, 19.6% vs. 17/130, 13.1% for the IRpost48XR group).ConclusionsNVP XR QD resulted in continued virologic suppression at weeks 48 and 144. While fewer patients remained in the study post‐week 48, both XR groups had high virologic response rates. Rates of serious AEs were modestly higher than seen at week 24 in both post‐week‐48 XR arms up to week 144, most likely due to the open‐label design of the study.

VTT Symposium 220. The 22nd Symposium on Fusion Technology. Helsinki, FI, 9 - 13 Sept. 2002. Book of Abstracts. Tähtinen, Seppo; Rintamaa, Rauno; Asikainen, Merja; Tuomisto, Harri (eds.), 466 ; This study was performed in the framework of the Socio-Economic Research on Fusion (SERF3), which is jointly conducted by Euratom and the fusion associations. Assessments of monetarized external impacts of the fusion fuel-cycle were previously performed (SERF1 and SERF2). Three different power plant designs were studied, with the main difference being the structural materials and cooling system used. The key variables and factors that significantly contributed to the value of externalities in the fusion fuel chain were identified and a set of design criteria and recommendations on how to reduce the external costs of fusion power was produced. In this third phase of the SERF project the external costs of three additional fusion power plant models using silicon carbide as structural material have been analyzed. External costs are those costs imposed on society by the fuel cycle but not reflected into the price of the electricity generated. This study has evaluated the external costs of three different power plant designs using silicon carbide as structural material. A comparison with other advanced generation technologies expected to be in use around 2050, when the first fusion power plant would be operative, has also been performed. These technologies include advanced fossil technologies, such as pressurized Fluidized Bed Combustion and Integrated Gasification Combined Cycle with carbon sequestration technologies; renewable technologies including fuel cells, photovoltaic systems and geothermal energy with energy storage devices and advanced fission reactors. The study uses a methodology for evaluating, in a standardised way, the external costs of electricity generation by different fuel cycles previously developed by the Commission of the European Union in the frame of the "ExternE" project. The ExternE methodology is a bottom-up methodology, with a marginal and site specific approach. Quantification of impacts is achieved through the damage function or impact pathway approach that follows the sequence of events linking a burden to an impact and subsequent monetary valuation. This means that it involves siting a power plant, and calculating its contribution to the environmental and health situation locally, regionally and globally. Fusion power plants using silicon carbide as structural material have higher efficiencies than plants using steel and this fact has a very positive effect on the external costs per kWh. External costs of these plants are in the lowest range of the external costs of advanced generation technologies indicating the outstanding environmental performance of fusion power. ; This study was performed in the framework of the Socio-Economic Research on Fusion (SERF3), which is jointly conducted by Euratom and the fusion associations. Assessments of monetarized external impacts of the fusion fuel-cycle were previously performed (SERF1 and SERF2). Three different power plant designs were studied, with the main difference being the structural materials and cooling system used. The key variables and factors that significantly contributed to the value of externalities in the fusion fuel chain were identified and a set of design criteria and recommendations on how to reduce the external costs of fusion power was produced. In this third phase of the SERF project the external costs of three additional fusion power plant models using silicon carbide as structural material have been analyzed. External costs are those costs imposed on society by the fuel cycle but not reflected into the price of the electricity generated. This study has evaluated the external costs of three different power plant designs using silicon carbide as structural material. A comparison with other advanced generation technologies expected to be in use around 2050, when the first fusion power plant would be operative, has also been performed. These technologies include advanced fossil technologies, such as pressurized Fluidized Bed Combustion and Integrated Gasification Combined Cycle with carbon sequestration technologies; renewable technologies including fuel cells, photovoltaic systems and geothermal energy with energy storage devices and advanced fission reactors. The study uses a methodology for evaluating, in a standardised way, the external costs of electricity generation by different fuel cycles previously developed by the Commission of the European Union in the frame of the "ExternE" project. The ExternE methodology is a bottom-up methodology, with a marginal and site specific approach. Quantification of impacts is achieved through the damage function or impact pathway approach that follows the sequence of events linking a burden to an impact and subsequent monetary valuation. This means that it involves siting a power plant, and calculating its contribution to the environmental and health situation locally, regionally and globally. Fusion power plants using silicon carbide as structural material have higher efficiencies than plants using steel and this fact has a very positive effect on the external costs per kWh. External costs of these plants are in the lowest range of the external costs of advanced generation technologies indicating the outstanding environmental performance of fusion power.

VTT Symposium 220. The 22nd Symposium on Fusion Technology. Helsinki, FI, 9 - 13 Sept. 2002. Book of Abstracts. Tähtinen, Seppo; Rintamaa, Rauno; Asikainen, Merja; Tuomisto, Harri (eds.), 469 ; This study was performed within the framework of the Socio-Economic Research on Fusion project (SERF3), which is jointly conducted by Euratom and the fusion associations. Assess-ments of monetarized external impacts of the fusion fuel cycle were performed previously (SERF1 and SERF2). In this study, several fusion power plant designs (SEAFP Models 1-6) were compared focus-ing on a part of the plant's life cycle: environmental impact of recycling the materials. The models differ mainly by the type materials used for core reactor components and type of cooling medium. Recycling is considered for materials replaced during normal operation, as well as materials from decommissioning of the plant. Several recycling schemes for activated parts have been suggested, one of which proposes using recycled fusion compo-nents when building new fusion reactors. Environmental impact was assessed and expressed as external costs normalised with the total electrical energy output during plants operation. This facilitates comparison with other options for electricity generation. The methodology used for this study was developed by the Commission of the European Union within the frame of the "ExternE" project. It is a bottom-up methodology, with a marginal and site specific approach. Quantification of impacts is achieved through the damage function or impact pathway approach that follows the sequence of events linking a burden to an impact and subsequent monetary valuation. This means that it involves siting a power plant, and calculating its contribution to the environ-mental and health situation locally, regionally and globally. Different material streams were used for activated recyclable parts and "common" recyclable parts. The regulations regarding transports and handling of radioactive materials will govern how they are treated. Some components will be possible to recycle only after up to 100 years of cooling, during which it must be stored. Even after that, some parts may have to be taken to final repositories. This amount varies between designs. The external costs of different scenarios for managing used fusion plant materials can be used as a contribution to the basis for decisions regarding waste from fusion plants. ; This study was performed within the framework of the Socio-Economic Research on Fusion project (SERF3), which is jointly conducted by Euratom and the fusion associations. Assess-ments of monetarized external impacts of the fusion fuel cycle were performed previously (SERF1 and SERF2). In this study, several fusion power plant designs (SEAFP Models 1-6) were compared focus-ing on a part of the plant's life cycle: environmental impact of recycling the materials. The models differ mainly by the type materials used for core reactor components and type of cooling medium. Recycling is considered for materials replaced during normal operation, as well as materials from decommissioning of the plant. Several recycling schemes for activated parts have been suggested, one of which proposes using recycled fusion compo-nents when building new fusion reactors. Environmental impact was assessed and expressed as external costs normalised with the total electrical energy output during plants operation. This facilitates comparison with other options for electricity generation. The methodology used for this study was developed by the Commission of the European Union within the frame of the "ExternE" project. It is a bottom-up methodology, with a marginal and site specific approach. Quantification of impacts is achieved through the damage function or impact pathway approach that follows the sequence of events linking a burden to an impact and subsequent monetary valuation. This means that it involves siting a power plant, and calculating its contribution to the environ-mental and health situation locally, regionally and globally. Different material streams were used for activated recyclable parts and "common" recyclable parts. The regulations regarding transports and handling of radioactive materials will govern how they are treated. Some components will be possible to recycle only after up to 100 years of cooling, during which it must be stored. Even after that, some parts may have to be taken to final repositories. This amount varies between designs. The external costs of different scenarios for managing used fusion plant materials can be used as a contribution to the basis for decisions regarding waste from fusion plants.

© 2018 American Medical Association. All rights reserved. Importance: Individually designed single-patient multi-crossover (n-of-1) trials can facilitate tailoring of treatments directed at various conditions, including chronic musculoskeletal pain (CMSP) but are potentially burdensome, which may limit uptake in research and practice. Objectives: To determine whether patients randomized to participate in an n-of-1 trial supported by a mobile health (mHealth) app would experience less pain and improved global health, adherence, satisfaction, and shared decision making compared with patients assigned to usual care. Design, Setting, and Participants: This randomized clinical trial compared participation in an individualized, mHealth-supported n-of-1 trial vs usual care. The participating 215 patients had CMSP for at least 6 weeks, had a smartphone or tablet with a data plan, were enrolled in northern California from July 2014 through July 2016, and were followed for up to 1 year by 48 clinicians in academic, community, Veterans Affairs, and military settings. Interventions: Intervention patients met with their clinicians and used a desktop interface to select treatments and trial parameters for an n-of-1 trial comparing 2 pain-management regimens. The mHealth app provided reminders to take designated treatments on assigned days and to upload responses to daily questions on pain and treatment-associated adverse effects. Control patients received care as usual. Main Outcomes and Measures: The primary outcome was change in the PROMIS (Patient-Reported Outcomes Measurement Information System) pain-related interference 8-item short-form scale (full scale range, 41-78) from baseline to 6 months. Secondary outcomes included patient-reported pain intensity, overall health, analgesic adherence, trust in clinician, satisfaction with care, medication-related shared decision making, and, for the n-of-1 group only, participant engagement and experience. Results: Among 215 patients (108 randomized to the n-of-1 intervention and 107 to control), 102 (47%) were women, and the mean (SD) age was 55.5 (11.1) years. At the 6-month follow-up, pain interference was reduced in both groups, though there was no difference between the intervention and control groups (-1.36 points; 95% CI, -2.91 to 0.19 points; P =.09). There were no advantages in secondary outcomes for intervention patients vs control patients except for higher medication-related shared decision making at 6 months (between-group difference, 11.9 points; 95% CI, 2.6-21.2 points; P =.01). Among patients assigned to the n-of-1 group, 88% (n = 86) affirmed that the mHealth app could help people like them manage their pain. Conclusions and Relevance: In this population of patients with CMSP, mHealth-supported n-of-1 trials were feasible and associated with a satisfactory user experience, but n-of-1 trial participation did not significantly improve pain interference at 6 months vs usual care. Trial Registration: ClinicalTrials.gov identifier: NCT02116621.