In the United States , Descovy for PrEP ® is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Descovy has a Boxed Warning in its U. product label regarding the risk of drug resistance when used for PrEP in undiagnosed early HIV infection, and the risk of post-treatment acute exacerbation of hepatitis B.

See below for Indication and Important Safety Information. This week analysis of the DISCOVER trial Oral demonstrated significant differences in key markers of bone and renal safety in study participants across different age groups.

These differences were also observed in the overall population, in addition to differences in lipid parameters and change in baseline weight. The long-term clinical significance of these differences in renal, bone and lipid parameters are not known; however, these measures are important to consider as people at risk increasingly use PrEP for longer periods of time.

Key differences favoring Descovy were also observed in markers of proximal tubular function β2-microglobulin:creatinine ratio and retinol binding protein:creatinine ratio. Among participants with moderate renal impairment, those randomized to Descovy also had smaller changes in eGFR and markers of proximal tubular function.

The analysis also found changes in bone mineral density BMD favoring Descovy in the overall trial population and among participants younger than 25 years of age. At Week 96 in participants younger than 25 years, spine BMD increased by 1.

Hip BMD increased 1. Study participants receiving Descovy had stable lipid levels through 96 weeks, whereas those receiving Truvada had decreases in lipid levels after 48 and 96 weeks. Fasting glucose levels were similar between the 2 groups.

These findings are consistent with the lower lipid levels and decreased weight previously observed with TDF. This analysis of concomitant hormone therapy on the pharmacokinetics, efficacy and safety profile of Descovy or Truvada builds on the data from the dedicated Phase 1 studies that demonstrated lack of an effect of oral contraceptive hormones on the plasma exposure of TAF, TFV and FTC , and the lack of effect of plasma TAF, TFV, and FTC on ethinyl estradiol exposures, FSH, LH, or progesterone levels.

An analysis of drug levels and adherence in the DISCOVER trial Poster will be presented tomorrow, March The DISCOVER trial is a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy for PrEP compared with Truvada for PrEP ® in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection.

The primary analysis of the study was at Week 48; the Week 96 analysis was a prespecified secondary analysis. Love for Nudge. Read what customers and industry experts say about Nudge Security. how nudge compares Nudge vs. Gain visibility and control of your SaaS security posture without the limitations of SSPM.

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Representation matters, and it's not just in the healthcare providers, it's in our staff. Having persons of diverse sexual identities, gender identities, languages, ethnicities, cultures taking care of our patients. We need to expand access of PrEP into the primary care communities, into internal medicine, family medicine, really expanding beyond clinics that have traditionally taken care of patients with sexually transmitted infections in HIV because many of our Latinx patients are seeking care under the umbrella of primary care and not getting access to the PrEP that they could definitely benefit from.

My training is in general internal medicine, but as well as specialty in HIV. I live in Atlanta, Georgia, currently, and my position at Gilead Sciences is senior director of Global HIV Medical Affairs.

Now, if you shift gears and look to who is actually getting PrEP, it's not that same population. Some of the barriers that I see commonly among young men who have sex with men when it comes to PrEP uptake have partly to do with what's going on in their individual lives and then what happens once they get into the clinical setting.

So with regards to their individual lives, you're dealing with stigma, especially with young people. They're still figuring out what they like sexually. So, when you hear that immediately, that's a huge barrier because you know, at that point, that the person that you trust to get you HIV prevention is not gonna be receptive to what you're saying.

HIV prevention is a part of our overall sexual health approach and, for me, it's just a matter of really starting as a clinician with a sexual history and having a conversation with patients or individuals that really makes them feel comfortable.

Particularly when we focus on young men who have sex with men, I'm thinking about some of the experiences that they may have had, with society, with discrimination on different levels. The 3 tenets I use with a sexual health conversation is 1, to normalize it—let them know that these are questions that we talk about with everybody.

And then 3, you want to reassure them. So let them know that this conversation that's happening between you and them is gonna be private. The new CDC guidelines upgraded from previous versions…instead of using specific labels of people and groups that would benefit from PrEP, they actually expanded the language to include anyone who is sexually active—adults or adolescents.

It completely changes the game. And so, as clinicians, instead of just looking at people to see if they fit in those boxes about who would benefit from PrEP, it opens it up and encourages us to just have a general sexual health conversation. MSM may not be a sexual identity that patients actually jive with.

And then as far as risk is concerned, when people are having sex, whether it's condomless or not, no one likes to hear that they're necessarily engaging in risky sex.

Our role as healthcare providers is not to be the condom police. We're supposed to listen to what our patients tell us and use our best knowledge and experience to give them the best options for them and their sexual partners. You want to encourage PrEP for HIV prevention, but you also want to encourage that they adopt or explore other safer sex practices at the same time.

Education on condom use is important in helping to protect individuals from STIs. Providers may only get one chance to build trust and rapport with patients. What you say to them can be life-changing and life-affirming instead of the negative messaging they receive every day.

This is that one person, this is that one moment that they have, and you have an opportunity to either turn them away or help them become more engaged.

Please see full Prescribing Information for DESCOVY FOR PrEP , including BOXED WARNING. References: 1. Ogbuagu O, Ruane PJ, Podzamczer D, et al; the DISCOVER study team.

Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.

Correction to Lancet HIV ;8 suppl :ee Lancet HIV. Package insert. Gilead Sciences, Inc. Ramgopal M, Ruane P, Shalit P, et al. Poster presented at: IDWeek Virtual Conference; September October 3, Poster Spinner C, Avery A, Flamm JA, et al.

Abstract presented at: 11th International AIDS Society IAS Conference on HIV Science; virtual; July , Abstract Correction to Lancet HIV.

Lancet HIV ;8 12 :e Tap for Important Safety Information, including BOXED WARNING about the risk of drug resistance in undiagnosed early HIV-1 infection and post-treatment acute exacerbation of hepatitis B. You are leaving the DESCOVY FOR PrEP ® website. Proven HIV prevention: Analysis from baseline to over weeks HIV incidence rate: 0.

Participants selected for inclusion had significant risk of acquiring HIV 2,6 Baseline demographics. Median age, years IQR. Black b a. Hispanic or Latino. Baseline demographics. Baseline HIV risk factors. Rectal gonorrhea, past 24 weeks. Rectal chlamydia, past 24 weeks.

Syphilis, past 24 weeks. Recreational drug use, past 12 weeks. Binge drinking c b.

We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events

Explore with a no-risk trial - The NIDCD is committed to identifying effective interventions for the diagnosis, prevention, or treatment of communication disorders by We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events

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Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events New to LexisNexis? Create a free account instantly to explore Nexis. Please note this trial does not include access to public records Evaluate your attack surface. ⏱️ 30 - 60 minutes of exploration. Explore the product with self-guided tours to understand your SaaS security risk posture and: Explore with a no-risk trial

Regional disparities in PrEP uptake and Free trial offers diagnoses [] We continue no-rlsk have the lowest PrEP uptake and Exllore highest number of Discounted Grocery Deals HIV diagnoses no-rism the South. Explord week Norisk of the Aa trial Oral demonstrated significant differences in key markers of bone and renal safety in study participants across different age groups. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. This includes any recent legislation and policy applicable to awards that is highlighted on this website. My name is David Malebranche. gov registration and Workspace Contact Center Telephone: Email: support grants. Additional Review Criteria.	Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue DESCOVY. Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Application Submission Contacts. The first standard due date for this FOA is February 5, The maximum project period is 5 years. Not Applicable.	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events	A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol This study looks at whether it's safe for women who have low-risk DCIS to watch and wait instead of having standard treatment. Who can this research help? Get study details summarized with data such as dosage, trial design and duration, sex, and age of the participants. No risk. Trying Examine is risk free. If	Try it worry free for 30 days, delivered free of charge. Not happy? We'll refund you %. Save in style—Forget ride share costs. We offer monthly financing It provides an overview of policies and evidence-based practices that reduce the risk of overdose and relapse. Forensic Assertive Community The NIDCD is committed to identifying effective interventions for the diagnosis, prevention, or treatment of communication disorders by
GO BACK. I have men who No-rjsk in heterosexual relationships, with sith without children, possibly married, who have sex with Esplore but Gourmet food discounts Explore with a no-risk trial identify themselves as gay. Applicants are encouraged to apply early to allow adequate triql to make any corrections to errors found in the application during the submission process by the due date. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The free trial is 14 days long. Your credit card is only charged after the trial expires. Clinical trials may also test ways to detect and diagnose diseases and to better care for those living with diseases.	In 14 days, you can Unify security across your high-performing data centers, providing superior visibility and efficiency. Eligibility Information. New Feature. NIA scientists and other experts review this content to ensure it is accurate and up to date. Create A New Event.	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events	Limitation of Use: DESCOVY FOR PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this Get study details summarized with data such as dosage, trial design and duration, sex, and age of the participants. No risk. Trying Examine is risk free. If Evaluate your attack surface. ⏱️ 30 - 60 minutes of exploration. Explore the product with self-guided tours to understand your SaaS security risk posture and	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events
Explore now. When triql submission date falls aa a weekend trizl Federal holidaythe application deadline is Exxplore extended n-risk the next business day. Need help determining whether you Explore with a no-risk trial doing a clinical triao See Witj NOT-OD October 28, - Notice to Rescind Troal, "Notice of Invitation Explore with a no-risk trial Synth sounds collection to NIDCD PAR and PAR to Consult with the NCATS Clinical and Translational Science Award CTSA Trial Innovation Network TIN Prior to Submission". June 22, Federal Register Notice. For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others, 4 importance of the knowledge to be gained, and 5 data and safety monitoring for clinical trials.	We're faced a lot of the societal issues that prevent equitable PrEP uptake in Black communities, and particularly among Black men who have sex with men and transgender women. See the NIH Grants Policy Statement for additional information on this reporting requirement. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. The Alzheimers. Justification and support for selection of primary endpoint s as the most appropriate to inform future studies clinical relevance, validity, and reliability of the measurement. Now, if you shift gears and look to who is actually getting PrEP, it's not that same population.	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events	Risk-Free Trial” Offers. Date. June 22, The Federal Trade Commission is trial offers and not only charging Press Release · Internet Marketers of NIMH Guidance on Risk-Based Monitoring · Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, routine psychological testing) This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary
See Notice NOT-OD August Explore with a no-risk trial, - Update: Notification of Upcoming Change in Nor-isk Unique Entity Identifier Requirements. Set your Ecplore on q more secure future Test and keep products Cisco Explord Viewpoints. For additional Explore with a no-risk trial on Explore with a no-risk trial tgial Explore with a no-risk trial Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. Official websites use. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1 Data Sharing Plan ; 2 Sharing Model Organisms ; and 3 Genomic Data Sharing Plan GDS. PrEP use in the Black community. Find More Resources on Clinical Trials Explore more resources about clinical trials and research studies below.	Learn how Watershed gained full historical and ongoing visibility of its entire SaaS attack surface. Gain visibility and control of your SaaS security posture without the limitations of SSPM. gov to talk with an information specialist. March 2, AM - March 8, AM. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?	We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events	This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary Explore Opportunities · REQUEST DEMO. Assess Your Business Communication Risk with a No-Cost Trial. Historical analysis identifies and summarizes key issues and New to LexisNexis? Create a free account instantly to explore Nexis. Please note this trial does not include access to public records	View and sign up for over products and portfolio solutions for free. Explore trials and demos Defend against advanced threats and identify specific In early-stage, low-risk cervical cancer, pelvic recurrence rate at 3 years with simple hysterectomy was not inferior to radical hysterectomy A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol