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250-323 Data Protection Administration for(R) Windows using NBU 5.0

Study Guide Prepared by Symantec Dumps Experts 250-323 Dumps and Real Questions 2019

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250-323 exam Dumps Source : Data Protection Administration for(R) Windows using NBU 5.0

Test Code : 250-323
Test Name : Data Protection Administration for(R) Windows using NBU 5.0
Vendor Name : Symantec
Q&A : 201 Real Questions

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Symantec Data Protection Administration for(R)

Symantec Advances built-in Cyber protection Platform | Real Questions and Pass4sure dumps

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Symantec broadcasts Updates to Platform, partners with Amazon, field, Splunk & Others | Real Questions and Pass4sure dumps

MOUNTAIN VIEW, Calif.--(enterprise WIRE)--Symantec Corp. (NASDAQ: SYMC), the area’s leading cyber security business, these days introduced that greater than 120 agencies have joined forces with Symantec to force down the can charge and complexity of cyber safety, whereas improving response times to protect companies against subtle threats. This includes primary avid gamers like AWS, box, IBM safety, Microsoft, Oracle, ServiceNow and Splunk, in addition to dozens of different technology innovators, who are now building or offering more than 250 products and capabilities that combine with Symantec’s built-in Cyber defense (ICD) Platform.

“The probability landscape all of us face isn't static and is continually on the flow, as are our customers and personnel, so techniques to deal with that variety of ambiance are very complicated”

Tweet this

This remarkable business collaboration reflects a “platform shift” in the cyber security trade, as new analysis from enterprise approach community (ESG) indicates enterprise consumers want to consolidate providers and undertake more integrated structures backed with the aid of an open ecosystem.

built-in defense improves security by means of expanding the velocity and effectiveness, whereas drastically decreasing the supplies required. To make that shift even simpler, Symantec also nowadays introduced vital innovations – together with a new widely wide-spread statistics exchange, shared administration capabilities, and upgraded information loss prevention utility that support purchasers stop untrusted apps before they compromise exclusive information. All are built on Symantec’s ICD Platform, which provides a unified framework for assistance protection, risk insurance policy, identity administration and compliance across endpoints, networks, purposes, and clouds.

“There’s a seismic shift going on in cyber protection,” observed artwork Gilliland, EVP and GM business items, Symantec. “The ancient means of combating cyber-attacks the use of fragmented tools has turn into too complicated and costly to control. built-in structures are the long run. We’re proud to be main this platform shift with a transparent vision and successful portfolio – along with a whole bunch of companions and thousands of experts working each day on the entrance traces to give protection to our customers. we're completely convinced that our finest protection going ahead is an integrated protection.”

New analysis Demonstrates the need for integrated structures

ESG currently published new client research showcasing how the inability of a cohesive safety technology strategy creates real issues for companies, leading clients to are seeking greater integrated systems and fewer, extra strategic vendors. Key findings in line with the analysis consist of:

  • greater than 80 percent of C-degree executives spoke of risk detection and response effectiveness is impacted with the aid of too many unbiased aspect tools1;
  • 53 percent of organizations have a frustrating scarcity of cyber security personnel and skills2; and
  • ninety one p.c of organizations are actively consolidating or because consolidating the cyber security carriers with whom they behavior business3.
  • “practically two-thirds of large firms surveyed use as a minimum 25 distinctive cyber security products. For safety operations facilities, managing disparate equipment can be ineffective, costly, and time drinking, above all considering the fact that the shortage of cyber security talents,” talked about Jon Oltsik, senior predominant analyst and fellow, ESG. “This explains why CISOs wish to consolidate and integrate their security infrastructure with systems and open architectures that provide superior developer support and convey a accomplice ecosystem with potent third-birthday party integrations.”

    Symantec Integrates items, functions and companions

    Symantec began constructing ICD two and a half years in the past with its acquisition of Blue Coat systems, which introduced most effective-of-breed net and cloud safety applied sciences to Symantec’s market-main endpoint, email and data loss prevention (DLP) technologies. at the time, Symantec saw and heard that purchasers have been spending gigantic time and supplies to integrate factor applied sciences with a purpose to derive real price from their cyber security investments. So, the enterprise invested in a methodology and roadmap to bring an integrated platform that greatly reduces can charge of operations whereas enhancing the velocity and accuracy of prevention, detection and response in an effort to cut back risk.

    since then, Symantec has:

  • Invested enormous R&D effort to integrate its products around key customer ache aspects – protecting tips in SaaS applications; integrating complementary applied sciences like cloud access safety broking service (CASB) and DLP; enhancing endpoint safety with superior endpoint detection and response (EDR) to offer protection to in opposition t targeted assaults; and securing infrastructure from endpoint to cloud for “Zero have faith” security implementations.
  • obtained creative security applied sciences like Fireglass, Skycure, Appthority, Javelin, and Luminate to handle emerging challenges – and at once integrated them into the Symantec portfolio.
  • Deepened its functions portfolio to deliver protection leaders with in-depth abilities in world threat intelligence, advanced hazard monitoring, cyber readiness, and incident response.
  • Opened its APIs and launched a expertise Integration accomplice software (TIPP) to do deeper integration work with key know-how avid gamers.
  • ICD Platform Earns vast Ecosystem guide

    Symantec now has greater than a hundred and twenty partners in TIPP, who're building or providing greater than 250 new purposes and features that combine with Symantec’s ICD Platform, so commercial enterprise customers can reduce the charge and complexity of their protection operations. in addition, Symantec is now launching a new “Innovation Playground” software within TIPP to simplify integration with startups. the brand new program will enable startup groups to leverage Symantec APIs and gain access to items, engineering substances, and customer innovation days.

    “as a way to cut back safety operations complexity and combat today’s more and more refined adversary, groups want products that work as a platform as an alternative of a military of point items working in silos,” referred to Oliver Friedrichs, VP of safety automation and orchestration at Splunk. “Splunk’s aid for the ICD Platform gives our joint clients with consolidated views throughout their protection infrastructure, including incidents flowing from endpoint, web, network and electronic mail security options.”

    “At box, safety is a precise priority and we are committed to providing our purchasers with effective controls to give protection to their sensitive content material,” talked about Niall Wall, senior vice chairman of partners at field. “Symantec is a founding member of the field trust Ecosystem. we're excited about Symantec’s built-in Cyber defense and the way it's going to support our mutual purchasers in the reduction of risk of statistics loss, notice advanced threats, and seamlessly collect our protection capabilities.”

    “safety analysts these days cope with increasingly complex threats, fragmented safety equipment, and siloed businesses,” said wealthy Telljohann, director of enterprise building at IBM safety. “To combat this we are since the cyber protection landscape is disturbing a shift to integrated platforms with a view to reduce complexity and value. we now have constructed an integration using Symantec ICD change, so the IBM Resilient Incident Response Platform can provide clever orchestration, automation, and enrichment of incidents prompted with the aid of Symantec ICD, allowing analysts to respond intelligently to threats.”

    ICD Platform Drives customer Adoption and cost

    As evidenced by Symantec’s fresh quarterly salary, further and further consumers are relocating past individual items to undertake the ICD platform and portfolio. as an instance:

  • In Europe, a family unit equipment company signed an eight-figure take care of Symantec, adopting a considerable footprint of the ICD platform;
  • In Asia Pacific, a tremendous securities and derivatives buying and selling trade expanded past Symantec endpoint security to undertake Symantec’s cloud protection stack; and
  • in the U.S., a worldwide Fortune 500 energy enterprise – initially a single product client – signed a seven-determine, multi-product, multi-carrier deal to construct an interior security operations middle.
  • “The hazard panorama we all face is not static and is at all times on the flow, as are our consumers and employees, so ideas to cope with that sort of environment are very complicated,” spoke of Emily Heath, vice president and chief tips safety officer, United airlines. “Visibility of your atmosphere and integration of solutions are a key a part of that method. as an example, if one security handle catches something, it is an awful lot greater productive for us if those controls are built-in and may speak seamlessly with each other to help with real time detection. additionally, if security suppliers take the time to integrate throughout the stack so we don’t should, that results in an excellent better influence.”

    Symantec Extends ICD Platform with New facets & features

    Symantec is introducing three new know-how improvements these days that prolong ICD for shared intelligence and shared administration across multiple technology add-ons, in addition to new “possibility mindful” data coverage capabilities:

  • ICD change: A popular records trade that shares hobbies, intelligence and actions throughout Symantec and third-party programs, improving visibility for protection teams and security operations facilities, which will take faster motion and enhance automation.
  • ICD supervisor: Shared management capabilities so one can deliver valued clientele with unified visibility into threats, guidelines and incidents, helping them to reduce incident response times from days to minutes.
  • records Loss Prevention 15.5: New statistics loss prevention (DLP) software that integrates with Symantec’s market-leading endpoint insurance policy suite to support clients stop untrusted apps before they compromise private information. This “risk conscious” information coverage is considered one of many breakthroughs made feasible because of Symantec’s ICD platform investments.
  • For more counsel on ICD, please talk over with:

    For more details about TIPP, please seek advice from:

    For greater details on how Symantec and companions are leading the shift to integrated Cyber protection, please consult with:

    For extra details on the cyber safety platform shift, please visit: ease-less-complicated

    to look a detailed mapping of Symantec product and accomplice integrations, please seek advice from:

    About Symantec

    Symantec company (NASDAQ: SYMC), the realm's main cyber safety business, helps companies, governments and individuals comfortable their most important data anywhere it lives. organizations internationally appear to Symantec for strategic, built-in options to look after towards refined attacks across endpoints, cloud and infrastructure. Likewise, a global group of more than 50 million americans and families count on Symantec's Norton and LifeLock product suites to protect their digital lives at home and across their instruments. Symantec operates one of the most world's largest civilian cyber intelligence networks, permitting it to see and offer protection to towards probably the most advanced threats. For more information, please consult with or join with us on facebook, Twitter, and LinkedIn.

    observe TO U.S. EDITORS: if you would like additional info on Symantec corporation and its products, please consult with the Symantec Newsroom at

    Symantec and the Symantec logo are trademarks or registered trademarks of Symantec supplier or its associates within the U.S. and different nations. different names can be emblems of their respective house owners.

    forward-looking STATEMENTS: Any forward-looking indication of plans for products is preliminary and all future unlock dates are tentative and are discipline to exchange. Any future unlock of the product or deliberate adjustments to product skill, performance, or characteristic are field to ongoing comparison by means of Symantec, and might or may also now not be applied and may now not be regarded company commitments with the aid of Symantec and should now not be relied upon in making purchasing decisions.

    1 supply: ESG research, hazard Detection and Response Survey, December 2018.

    2 source: ESG analysis document, 2019 technology Spending Intentions Survey, February 2019.

    three supply: ESG master Survey results, Cybersecurity panorama: The Evolution of business-classification companies and systems, October 2018.

    Symantec Leads exceptional business Collaboration to force Down can charge and Complexity of Cyber security | Real Questions and Pass4sure dumps

    MOUNTAIN VIEW, Calif.--(business WIRE)--

    greater than 120 companions, together with AWS, field, IBM safety, Microsoft, Oracle, ServiceNow and Splunk, commit to Symantec’s built-in Cyber protection Platform

    Symantec Corp. (SYMC), the world’s main cyber security enterprise, nowadays announced that more than a hundred and twenty corporations have joined forces with Symantec to drive down the charge and complexity of cyber protection, while improving response instances to protect organisations in opposition t refined threats. This comprises principal players like AWS, container, IBM safety, Microsoft, Oracle, ServiceNow and Splunk, as well as dozens of alternative know-how innovators, who are now constructing or supplying more than 250 items and services that combine with Symantec’s built-in Cyber defense (ICD) Platform.

    This remarkable business collaboration displays a “platform shift” within the cyber protection industry, as new research from enterprise strategy group (ESG) suggests business customers want to consolidate providers and adopt greater integrated structures backed via an open ecosystem.

    integrated protection improves safety through expanding the speed and effectiveness, whereas enormously cutting back the supplies required. To make that shift even easier, Symantec also nowadays announced essential innovations – including a brand new ordinary data change, shared management capabilities, and upgraded information loss prevention utility that help customers cease untrusted apps before they compromise exclusive information. All are developed on Symantec’s ICD Platform, which provides a unified framework for counsel insurance policy, danger coverage, id management and compliance across endpoints, networks, purposes, and clouds.

    “There’s a seismic shift occurring in cyber safety,” mentioned art Gilliland, EVP and GM enterprise products, Symantec. “The historical method of fighting cyber-assaults the use of fragmented equipment has become too complex and costly to control. integrated platforms are the longer term. We’re proud to be main this platform shift with a clear vision and successful portfolio – together with a whole lot of companions and thousands of specialists working daily on the front lines to offer protection to our customers. we're fully convinced that our top-quality protection going ahead is an built-in defense.”

    New analysis Demonstrates the want for built-in structures

    ESG currently posted new consumer research showcasing how the inability of a cohesive safety technology strategy creates actual problems for agencies, main valued clientele to are looking for greater built-in platforms and fewer, more strategic providers. Key findings in line with the analysis include:

  • greater than eighty p.c of C-degree executives talked about danger detection and response effectiveness is impacted by way of too many unbiased point tools1;
  • fifty three % of corporations have a complex scarcity of cyber protection staff and skills2; and
  • 91 % of businesses are actively consolidating or when you consider that consolidating the cyber security vendors with whom they behavior business3.
  • “well-nigh two-thirds of tremendous firms surveyed use at the least 25 distinctive cyber protection items. For security operations centers, managing disparate equipment can be ineffective, expensive, and time drinking, certainly because the scarcity of cyber protection competencies,” pointed out Jon Oltsik, senior important analyst and fellow, ESG. “This explains why CISOs wish to consolidate and combine their protection infrastructure with systems and open architectures that give advanced developer support and convey a associate ecosystem with potent third-celebration integrations.”

    Symantec Integrates items, functions and companions

    Symantec begun constructing ICD two and a half years in the past with its acquisition of Blue Coat methods, which delivered choicest-of-breed net and cloud safety technologies to Symantec’s market-main endpoint, e-mail and facts loss prevention (DLP) technologies. on the time, Symantec saw and heard that valued clientele had been spending large time and substances to combine point technologies in an effort to derive true cost from their cyber safety investments. So, the business invested in a methodology and roadmap to deliver an built-in platform that enormously reduces can charge of operations whereas enhancing the speed and accuracy of prevention, detection and response in an effort to reduce risk.

    when you consider that then, Symantec has:

  • Invested huge R&D effort to combine its items around key client pain points – conserving guidance in SaaS functions; integrating complementary applied sciences like cloud access security broking service (CASB) and DLP; bettering endpoint safety with advanced endpoint detection and response (EDR) to offer protection to towards centered assaults; and securing infrastructure from endpoint to cloud for “Zero believe” protection implementations.
  • acquired resourceful safety applied sciences like Fireglass, Skycure, Appthority, Javelin, and Luminate to handle rising challenges – and right away built-in them into the Symantec portfolio.
  • Deepened its services portfolio to give safety leaders with in-depth capabilities in international danger intelligence, advanced danger monitoring, cyber readiness, and incident response.
  • Opened its APIs and launched a expertise Integration associate program (TIPP) to do deeper integration work with key expertise gamers.
  • ICD Platform Earns broad Ecosystem aid

    Symantec now has more than a hundred and twenty partners in TIPP, who are building or providing greater than 250 new purposes and capabilities that combine with Symantec’s ICD Platform, so business customers can cut back the can charge and complexity of their protection operations. in addition, Symantec is now launching a brand new “Innovation Playground” software inside TIPP to simplify integration with startups. the brand new program will allow startup teams to leverage Symantec APIs and benefit entry to products, engineering materials, and customer innovation days.

    Story continues

    “in an effort to reduce protection operations complexity and fight these days’s more and more sophisticated adversary, companies need products that work as a platform as a substitute of an army of point items working in silos,” talked about Oliver Friedrichs, VP of security automation and orchestration at Splunk. “Splunk’s aid for the ICD Platform gives our joint shoppers with consolidated views across their safety infrastructure, including incidents flowing from endpoint, internet, network and e mail protection options.”

    “At container, safety is a appropriate priority and we're dedicated to presenting our clients with effective controls to offer protection to their sensitive content,” spoke of Niall Wall, senior vice president of companions at field. “Symantec is a founding member of the container believe Ecosystem. we're enthusiastic about Symantec’s integrated Cyber defense and how it will assist our mutual shoppers reduce risk of facts loss, observe advanced threats, and seamlessly compile our security capabilities.”

    “protection analysts these days cope with more and more complicated threats, fragmented safety tools, and siloed organizations,” observed rich Telljohann, director of business building at IBM safety. “To fight this we're considering that the cyber protection landscape is annoying a shift to built-in systems in an effort to reduce complexity and price. we have developed an integration using Symantec ICD change, so the IBM Resilient Incident Response Platform can provide clever orchestration, automation, and enrichment of incidents caused with the aid of Symantec ICD, allowing analysts to reply intelligently to threats.”

    ICD Platform Drives consumer Adoption and value

    As evidenced by Symantec’s recent quarterly profits, more and more shoppers are moving beyond particular person products to undertake the ICD platform and portfolio. for example:

  • In Europe, a family unit equipment company signed an eight-figure contend with Symantec, adopting a substantial footprint of the ICD platform;
  • In Asia Pacific, an enormous securities and derivatives buying and selling change increased beyond Symantec endpoint safety to adopt Symantec’s cloud safety stack; and
  • within the U.S., a world Fortune 500 energy business – firstly a single product consumer – signed a seven-figure, multi-product, multi-provider deal to build an internal safety operations center.
  • “The chance panorama we all face isn't static and is normally on the flow, as are our purchasers and personnel, so techniques to deal with that form of environment are very complicated,” observed Emily Heath, vice president and chief suggestions safety officer, United airways. “Visibility of your environment and integration of solutions are a key a part of that method. for example, if one protection handle catches whatever, it's a lot extra efficient for us if these controls are integrated and may speak seamlessly with each different to assist with precise time detection. moreover, if protection providers make the effort to combine across the stack so we don’t must, that effects in a fair improved result.”

    Symantec Extends ICD Platform with New facets & services

    Symantec is introducing three new know-how innovations these days that prolong ICD for shared intelligence and shared administration throughout distinct expertise components, as well as new “hazard aware” information protection capabilities:

  • ICD trade: A customary records alternate that shares hobbies, intelligence and actions throughout Symantec and third-celebration systems, enhancing visibility for security groups and security operations centers, so we can take sooner action and increase automation.
  • ICD manager: Shared management capabilities on the way to supply consumers with unified visibility into threats, policies and incidents, helping them to cut back incident response times from days to minutes.
  • records Loss Prevention 15.5: New statistics loss prevention (DLP) utility that integrates with Symantec’s market-main endpoint insurance plan suite to assist customers cease untrusted apps before they compromise personal facts. This “possibility conscious” statistics insurance plan is one in every of many breakthroughs made viable because of Symantec’s ICD platform investments.
  • For extra guidance on ICD, please seek advice from:

    For greater particulars about TIPP, please seek advice from:

    For extra particulars on how Symantec and companions are leading the shift to integrated Cyber protection, please seek advice from:

    For greater details on the cyber protection platform shift, please seek advice from:

    to see an in depth mapping of Symantec product and partner integrations, please visit:

    About Symantec

    Symantec organisation (SYMC), the realm's main cyber protection company, helps agencies, governments and americans comfortable their most important information anyplace it lives. companies across the world appear to Symantec for strategic, integrated options to safeguard in opposition t refined attacks across endpoints, cloud and infrastructure. Likewise, a global group of greater than 50 million people and households count on Symantec's Norton and LifeLock product suites to protect their digital lives at domestic and across their contraptions. Symantec operates one of the world's greatest civilian cyber intelligence networks, enabling it to look and give protection to against essentially the most superior threats. For more information, please talk over with or connect with us on facebook, Twitter, and LinkedIn.

    be aware TO U.S. EDITORS: if you'd like additional info on Symantec organisation and its products, please seek advice from the Symantec Newsroom at

    Symantec and the Symantec brand are emblems or registered logos of Symantec corporation or its associates within the U.S. and other international locations. different names could be trademarks of their respective owners.

    ahead-searching STATEMENTS: Any ahead-looking indication of plans for items is preliminary and all future unencumber dates are tentative and are discipline to exchange. Any future release of the product or planned changes to product capacity, functionality, or characteristic are subject to ongoing evaluation with the aid of Symantec, and may or can also not be carried out and may not be regarded enterprise commitments by means of Symantec and may no longer be relied upon in making paying for selections.

    1 source: ESG analysis, chance Detection and Response Survey, December 2018.

    2 supply: ESG research record, 2019 technology Spending Intentions Survey, February 2019.

    three supply: ESG master Survey outcomes, Cybersecurity panorama: The Evolution of business-type vendors and structures, October 2018.

    View source edition on

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    StorOne storage is set to disrupt the software-defined market | real questions and Pass4sure dumps

    Toigo Partners International

    In the late 1990s, Gal Naor started a company, StorWiz (he later changed the name to StorWize), to advance a technology he developed for delivering data compression at wire speed. Not only was this a cool idea and one that struck me as much more efficient than most algorithmic data deduplication approaches in vogue at the time, it had the nifty advantage of being software-based. You could apply the technology to just about any type of storage to squeeze out the bandwidth required for data transfers and space for storing bits when they came to rest. IBM bought StorWize in 2010, making Naor and his investors rather well to do.

    That was the last I had heard of Naor for years. I thought he'd had his fill of storage technology and gotten out of the business just in time to miss the industry consolidation that dramatically reduced the number of vendors in recent years. As it turned out, Naor had "gone quiet" for the past seven years and not just to bask in the afterglow of his success. He was engaged in serious R&D for his next big adventure. Now, with new technology based on more than 50 patents, Naor has re-entered the fray at the helm of software-defined storage startup StorOne.

    His new tech, called TRU Storage, is closer to what we all thought software-defined storage would be when the SDS concept was first floated a few years back. The acronym TRU stands for Total Resource Utilization. In this case, it's a designation that's more than aspirational.

    I've been acquainting myself with TRU Storage over the last few months. With it, StorOne storage might just set the bar for SDS going forward. (I have no stake in the company or contract to promote their wares.)

    Total Resource Utilization

    Gartner reported last summer that SDS and hyper-convergence had reduced the cost per terabyte by increasing the amount of storage a single administrator could manage. However, they had also caused a 10% decrease in the utilization efficiency of storage capacity across the enterprise. The reason for the utilization fail: Storage was being siloed behind different hypervisors in a way that prohibited shared use by different workloads operating under different hypervisor brands.

    With S1, the StorOne TRU Storage product name, neither the workload, nor the hypervisor, nor the hardware used to build the storage infrastructure matters. StorOne storage technology creates universal storage pools that can include any storage gear connected via any protocol and enables any workload to use that resource. Block, file and object storage can share the same resource, volume and drive. Remarkably, S1 optimizes the overall infrastructure's performance and capacity to more than 90% of advertised peaks. That means you sacrifice fewer IOPS and terabytes in an S1 environment compared with other current approaches, be it converged or hyper-converged infrastructure.

    StorOne's results have yet to be evaluated by the Storage Performance Council (SPC) or other benchmarking outfits. Publishing results would likely prove problematic anyway, given the pushback the SPC received when it published the results of DataCore Software testing a couple years ago. Like StorOne, software-defined storage vendor DataCore took an unconventional path to accelerating I/O -- a software shim that created a parallel I/O processing engine out of unused logical CPU cores, thereby accelerating I/O processing and reducing latency by amazing levels.

    Big box vendors like Hewlett Packard Enterprise and IBM thought the resulting comparison unfair, since it demonstrated the same IOPS and latencies could be obtained from commodity servers and white box arrays as from highly configured big iron arrays. Smoke still billows from vendor ears, and a few even offer off-the-record disparagement of SPC methodology to this day.

    A potential disrupter

    StorOne storage is similar to DataCore in terms of its disruptive potential, but it is also different. TRU Storage does not use DRAM caching as DataCore does. It hardly uses caches at all. S1 software runs as a virtual machine under ESXi. It uses a surprisingly low amount of resources in an all-virtual environment to immediately deliver IOPS that exceed the performance-leading all-flash arrays, according to StorOne lab tests.

    TRU Storage is closer to what we all thought software-defined storage would be when the concept was first floated a few years back.

    Recently, StorOne released a test result document, demonstrating 1.7 million IOPS using 24 Western Digital flash drives (random reads), 15 gigabyte per second sequential reads, 7.5 GBps sequential writes and 10 GBps for mixed workloads of 80/20 reads/writes. By comparison, StoreOne noted, an all-flash array competitor in the market required four times the hardware and expense to deliver only 1.5 million IOPS. For the record, these are internal tests performed by StorOne and not by standard benchmark testing outfits.

    A persistent integrity guarantee promises full recovery from any hardware or environment failure without data loss. This is enabled by an integrated enterprise data protection and data retention feature that permits zero-time backup and restore and unlimited snapshots with no performance degradation. StorOne storage delivers this functionality without requiring rejiggering RAID levels on connected equipment, adding memory or processor or changing configurations.

    S1 is quite literally plug-and-play.

    Perhaps the most disruptive feature of StorOne storage is its price tag. Naor says S1 will be offered as software, as a service or bundled with white box arrays for the price of a penny per gigabyte from the software-defined storage vendor. That is lower than most cloud storage offerings, all of which don't offer the performance characteristics or integrity guarantee of S1.

    I'll be watching to see how the tech plays out at scale and in geographically distributed installations, including hybrid cloud on-premises infrastructure. When I bring this up, Naor simply smiles his "just stand by and be patient" smile, as he insists TRU Storage technology will scale without problems. Given his record of technological success, I'm willing to give him the benefit of the doubt.

    Postexposure Protection of Macaques from Vaginal SHIV Infection by Topical Integrase Inhibitors | real questions and Pass4sure dumps


    Coitally delivered microbicide gels containing antiretroviral drugs are important for HIV prevention. However, to date, microbicides have contained entry or reverse transcriptase inhibitors that block early steps in virus infection and thus need to be given as a preexposure dose that interferes with sexual practices and may limit compliance. Integrase inhibitors block late steps after virus infection and therefore are more suitable for post-coital dosing. We first determined the kinetics of strand transfer in vitro and confirmed that integration begins about 6 hours after infection. We then used a repeat-challenge macaque model to assess efficacy of vaginal gels containing integrase strand transfer inhibitors when applied before or after simian/human immunodeficiency virus (SHIV) challenge. We showed that gel containing the strand transfer inhibitor L-870812 protected two of three macaques when applied 30 min before SHIV challenge. We next evaluated the efficacy of 1% raltegravir gel and demonstrated its ability to protect macaques when applied 3 hours after SHIV exposure (five of six protected; P < 0.05, Fisher’s exact test). Breakthrough infections showed no evidence of drug resistance in plasma or vaginal secretions despite continued gel dosing after infection. We documented rapid vaginal absorption reflecting a short pharmacological lag time and noted that vaginal, but not plasma, virus load was substantially reduced in the breakthrough infection after raltegravir gel treatment. We provide a proof of concept that topically applied integrase inhibitors protect against vaginal SHIV infection when administered shortly before or 3 hours after virus exposure.


    HIV-1 continues to spread globally, highlighting the need to develop efficacious biomedical interventions to limit its transmission. In addition to vaccine development, there are several antiretroviral (ARV) drug–based intervention strategies currently being advanced, including oral preexposure prophylaxis (PrEP) treatment as prevention as well as topical PrEP with gels or other ARV delivery methods such as intravaginal rings and tablets (1–3). ARV gels have several advantages for HIV prevention. When applied to the mucosal site of virus exposure, gels can rapidly dose tissues with drug concentrations that are much higher than those achieved by oral dosing and with minimal systemic drug exposures and drug toxicities (3–9). Topical gels are user-controlled and can be optimally formulated with a single drug or in combination for both vaginal and rectal application (4–6, 10).

    The CAPRISA 004 trial evaluated the safety and effectiveness of a vaginal gel containing 1% tenofovir (TFV) and provided the first evidence of efficacy by this intervention strategy. The study demonstrated a 39% reduction of HIV acquisition in women who applied the gel pericoitally (1). Effectiveness was dependent on adherence and was found to increase to 54% in women who reported frequent gel use (>80% adherence) compared to only 28% in women who were <50% adherent. A subsequent study (VOICE) evaluating the same gel formulation in a noncoital daily dosing modality was stopped because of the absence of protection (2). TFV testing in plasma revealed poor adherence among participants, likely explaining the lack of efficacy (3). These data and similar findings from oral PrEP studies highlight the challenges of identifying intervention strategies that have both high biological efficacy and enhanced user compliance (4).

    Coitally used topical gels are important HIV prevention methods. However, to date, all such products rely on a preexposure dose that can interfere with sexual practices, and may be limited by partner’s acceptance and the need to anticipate sex. We reasoned that a topical product that can be applied by women after sex will have less impact on sexual practices, have better user control, and circumvent the need for sex anticipation and partner acceptance. These advantages can all potentially enhance compliance and effectiveness. However, all topical ARV-based gels in development use entry or reverse transcriptase (RT) inhibitors that block early steps in the virus infection cycle, which raises questions about their suitability for postexposure prophylaxis (PEP) (1, 5–7). Macaque models of rectal or vaginal transmission of the simian immunodeficiency virus (SIV) or the chimeric simian/human immunodeficiency virus (SHIV) have provided important data confirming the efficacy of topical gels with RT inhibitors such as TFV and MIV150 when applied before virus challenge, but demonstrated loss or substantial reduction in efficacy when applied 1 to 2 hours after virus challenge (8–10). These data likely reflect the need to adequately dose mucosal tissues with RT inhibitors before virus exposure and suggest that drugs from different classes that target later steps in virus infection may be more efficacious for PEP.

    HIV or SIV integration into the host DNA is the last step before an irreversible infection of a cell takes place. Integration is a multistep process catalyzed by the viral integrase that follows reverse transcription and starts in the cytoplasm with 3′-end processing of viral DNA, continues with translocation of the processed DNA to the nucleus, and is completed by integrating the viral DNA into the host chromosome by a strand transfer mechanism (11, 12). The integration process can be inhibited at various stages by three main classes of integrase inhibitors: 3′-processing inhibitors (13), strand transfer inhibitors (14), and macromolecular complex LEDGF/p75-IN inhibitors (15). Strand transfer inhibitors are the most developed and have been validated as potent inhibitors of HIV replication in vitro, ex vivo, in animal studies, and in clinical trials (16, 17). The mechanism of action of strand transfer inhibitors is characterized by their ability to chelate the Mg2+ ions in the catalytic core domain of integrase, thereby disrupting the interaction between the integrase/viral complementary DNA preintegration complex and the target DNA (18). The only clinically approved integrase inhibitors licensed for the treatment of HIV-infected persons are raltegravir (RAL), elvitegravir, and dolutegravir, all of which are strand transfer inhibitors (14, 19). The compound L-870812 (L-812) is a potent investigational strand transfer inhibitor and has been shown to be effective in reducing SIV replication in macaques (16). For PEP, blocking the last step in virus integration by strand transfer inhibitors can be advantageous because it can extend the post-coital dosing window (14, 20). RAL and L-812 are equally potent on both HIV and SIV integrase, with IC50 (50% inhibitory concentration) in the nanomolar range (1 to 4 nM), which provides an opportunity to test in macaque models the concept of topical prophylaxis by this class of drugs for both pre- and postexposure protection (16, 17).

    Here, we used a repeat low-dose vaginal challenge macaque model to evaluate the efficacy of gels containing L-812 or RAL administered before or after virus challenge, respectively. This well-established macaque model has several advantages, including the use of pigtailed macaques, which have a menstrual cycle and vaginal anatomy similar to women, an inoculum dose with viral RNA levels in the range similar to those detected in seminal fluid, twice-weekly virus challenges to mimic high-risk human exposure, and an SHIVSF162p3 inoculum that uses an R5-tropic envelope similar to that of most transmitted HIV (10, 21, 22). The repeated challenges in this model have the added advantage of increasing statistical power without requiring large groups of animals because they allow measurement of protection over more than one transmission event per animal. We also performed time-of-drug addition studies in vitro to define the window for strand transfer inhibition and to better inform in vivo dosing.

    RESULTS Gel formulation and impact of vaginal fluids on antiviral activity

    L-812 was successfully formulated in a hydroxyethyl cellulose (HEC) gel at a maximum solubility of 2.3 mg/ml (0.23%). Because of higher water solubility, RAL was formulated in a HEC gel at a concentration of 10 mg/ml (1%). Both gels were clear, viscous, and free of particulates and remained highly active for up to 1 year at room temperature. To investigate whether biological factors present in the vagina, including mucus, enzymes, and microflora, may compromise the stability and potency of RAL gel, we assessed the antiviral activity of RAL gel incubated in cervicovaginal fluids (CVFs). Figure 1 shows that CVF had no impact on RAL activity because no difference in IC50 was observed between RAL incubated in CVF (IC50 = 2.6 ± 1.1 nM) or saline (1.7 ± 1.2 nM).

    Fig. 1. Antiviral activity of RAL gel is maintained in the presence of vaginal fluids.

    A TZM-bl reporter cell line was used to evaluate antiviral activity (IC50) of RAL gel preincubated (24 hours) in saline buffer or CVF. Data are means ± SE of three independent experiments.

    Time-of-drug addition reveals a wide window for inhibition by integrase inhibitors

    To better define the timing of reverse transcription and integration and to inform the dosing modality in vivo, we performed time-of-drug addition experiments using single-cycle infections of TZM-bl cells with vesicular stomatitis virus (VSV)–pseudotyped HIV-1. The kinetics of postexposure inhibition by the RT inhibitor TFV was compared with that of RAL. Figure 2 shows that TFV maintained high (>95%) protection up to 2 hours after infection, but was only ~50% protective when added at 5 hours after infection. In contrast, RAL provided high protection (>90%) at 6 hours and remained above 50% protection for up to 10 hours after infection. These data suggest that strand transfer is delayed by at least 4 hours after reverse transcription, providing a longer window to block infection with integrase inhibitors than inhibitors of reverse transcription.

    Fig. 2. Kinetics of the window of inhibition by RT and integrase inhibitors.

    Protection of TZM-bl cells from infection with VSV-HIV was evaluated after addition of the RT inhibitor TFV or the integrase inhibitor RAL at the indicated times after infection. Data are means ± SE of three independent experiments.

    Preexposure protection by a vaginal integrase inhibitor gel

    We first evaluated whether topically applied integrase inhibitors administered before virus challenge protected macaques from SHIV infection. Three pigtailed macaques received vaginal gel containing 0.23% L-812 30 min before vaginal SHIVSF162p3 exposure. Infection outcome after 14 twice-weekly vaginal challenges was evaluated against 10 untreated controls receiving placebo gel (1 real-time and 9 historic controls). All controls received the same placebo gel and were challenged with the same virus stock under identical experimental conditions. In this model, pigtailed macaques are more susceptible to infection during the late luteal phase of the menstrual cycle (10, 23). As previously described, the risk for infection was calculated per month or menstrual cycle (10). Figure 3A shows the infection rates in animals treated with L-812 and placebo gel. Nine of 10 controls (90%) became infected after 14 challenges over a 2-month period; seven, including the real-time control, were infected after eight challenges (1 month), and two were infected during the second month. In contrast, two of the three macaques treated with L-812 gel remained uninfected after 14 challenges (estimated efficacy = 76%; P = 0.057, Fisher’s exact test); the breakthrough infection occurred after nine challenges (week 5), whereas both protected animals remained seronegative and had undetectable SHIV sequences in plasma or PBMCs throughout the 10-week follow-up period. L-812 gel efficacy was estimated at 76% on the basis of 9 of 13 infections per months (or cycles) at risk among controls and 1 of 6 for treated animals.

    Fig. 3. Protection by PrEP and PEP with vaginal gels containing integrase inhibitors.

    Survival curves represent the cumulative percentage of uninfected macaques as a function of the number of months at risk for infection during the study period (eight challenges per month). (A) Gel containing L-812 (solid line) or placebo (dotted line) was applied vaginally 30 min before each SHIV exposure (up to 14 SHIV exposures). Controls include one real-time (solid circle) and nine historic controls. (B) Gel containing RAL (solid line) or placebo (dotted line) was applied vaginally 3 hours after SHIV exposure (up to 20 SHIV exposures).

    Postexposure protection by RAL gel

    We next explored the efficacy of 1% RAL gel applied 3 hours after vaginal SHIV exposure. The 3-hour dosing interval falls within the dosing window for maximal in vitro inhibition of strand transfer and is behaviorally feasible for post-coital application. Figure 3B shows infection outcomes in macaques that were challenged twice weekly for 2.5 months (about two menstrual cycles) with SHIVSF162p3 and administered placebo (n = 4) or 1% RAL (n = 6) gel 3 hours after each virus challenge. All four macaques that received placebo gel became infected by 10 weeks (20 challenges). In contrast, five of six macaques treated with RAL gel 3 hours after SHIV exposure remained uninfected after 20 SHIV exposures and the 10-week follow-up period. All infected macaques, including the breakthrough infection, exhibited typical SHIV RNA viremia and detectable proviral DNA in PBMCs and seroconverted 1 to 3 weeks after first detectable plasma SHIV RNA was observed. Risk for infection differed by study group (P < 0.05, Fisher’s exact test), with RAL gel efficacy estimated at 84% on the basis of 4 of 7 infections per months (or cycles) at risk among controls and 1 of 11 for treated animals. Together, these data suggest that topically applied integrase inhibitors can prevent vaginal infection when administered shortly before or up to 3 hours after SHIV exposure.

    Systemic drug concentrations after vaginal gel dosing

    Measuring drug exposure in blood is critical to understanding kinetics of drug release and systemic absorption after vaginal gel dosing. Systemic drug exposures are also important for determining impact on acute viremia and emergence of drug resistance in animals that fail gel prophylaxis and continue receiving gel treatment. We measured L-812 and RAL concentrations in plasma 30 min after each gel administration to determine systemic drug exposure at time of challenge and also assessed the impact of the menstrual cycle on vaginal drug absorption. We have previously noted with gels containing TFV or emtricitabine (FTC) that systemic drug exposure peaks within 1 hour after gel dosing and is highly influenced by the menstrual cycle with higher drug concentrations in plasma observed during the progesterone-dominated luteal phase when the vaginal epithelium is thin (24, 25). We analyzed longitudinally both progesterone and drug concentrations in plasma in all macaques that were treated with L-812 or RAL gel (Fig. 4, A and B). With the exception of one (PMl), all macaques experienced at least two menstrual cycles during the study period. Plasma drug concentrations 30 min after vaginal dosing showed similar trends in all animals with substantially higher concentrations consistently detected after peak progesterone. The mean concentration of L-812 and RAL 1 week after peak progesterone (late luteal phase) was 115.3 ± 20.8 ng/ml (range, 74 to 140) and 111 ± 31.3 ng/ml (range, 0 to 260) compared to only 1.5 ± 0.5 ng/ml (range, 0 to 6) and 5.8 ± 4.9 ng/ml (range, 0 to 39.8) 1 week before peak progesterone (late follicular phase). The data confirm that both drugs were rapidly released from the HEC-based gel formulation. The longitudinal analysis of plasma drug concentrations in the two breakthrough infections (PBg-2 and PSz-1) revealed similar peak drug levels and absorption trends to animals that were protected. PSz-1 had detectable RAL in plasma at the estimated time of infection, 7 days (226 ng/ml) to 10 days (259 ng/ml) before the first detectable SHIV RNA. However, PBg-2 had undetectable L-812 at day 7 and 17 ng/ml at day 10. Although limited to only two animals, these results do not show a clear association between drug concentrations in plasma and protection.

    Fig. 4. Longitudinal analysis of plasma drug and progesterone concentrations in pigtailed macaques dosed with vaginal gels containing integrase inhibitors.

    (A) Three macaques were dosed twice weekly with L-812 gel (dotted line); shaded areas show progesterone concentrations. (B) Six macaques dosed twice weekly with RAL gel (dotted line); shaded areas show progesterone concentrations. All drug concentrations were analyzed from plasma collected 30 min after each vaginal gel application. SHIV+ denotes first detectable SHIV RNA in plasma.

    Virus replication in breakthrough infections

    We next explored the impact of continued vaginal gel dosing on plasma and vaginal virus shedding in macaques PBg-2 and PSz-1, which became infected despite receiving L-812 or RAL gel, respectively. Infected macaques continued to receive twice-weekly placebo (n = 5), L-812 (n = 1), or RAL (n = 1) gel treatment for up to 8 weeks (16 gel applications) after the first SHIV RNA was detected in plasma. Plasma SHIV RNA detected in both breakthrough infections was evaluated against the five real-time controls. Virus shedding was assessed only in the RAL failure and controls receiving placebo gel. Figure 5A shows the virus load kinetics in both breakthrough infections compared to controls. The peak viremia in PBg-2 (6.08 log10 RNA copies/ml) and PSz-1 (6.7 log10 RNA copies/ml) was similar to the median peak viremia of the five untreated controls (7.01 ± 0.98 log10 RNA copies/ml), showing no difference in acute viremia (P = 0.29, Wilcoxon rank sum test). In contrast, Fig. 5B reveals that the peak vaginal SHIV RNA (3.5 log10 copies/ml) and the frequency (4 of 15) of SHIV RNA detected in vaginal fluids were both significantly lower in PSz-1 than in placebo-treated animals that had a median SHIV RNA peak of 5.2 log10 ± 0.42 copies/ml (P = 0.007) and frequency of 36 of 60 (P < 0.0001), respectively. The reduction in vaginal SHIV shedding could reflect the antiviral activity by RAL gel.

    Fig. 5. Plasma and vaginal virus loads in macaques with breakthrough infection and controls.

    (A) Individual virus load kinetics in breakthrough infections under continued twice-weekly dosing with gel containing L-812 (diamonds) or RAL (circles) compared to median virus loads of controls (n = 5, dotted black line). Time 0 indicates first detection of SHIV in plasma. (B) Individual virus load kinetics in vaginal secretions collected twice weekly before dosing with gel containing RAL (solid line; large circles) or placebo (n = 4, black dotted lines). Filled symbols indicate samples sequenced for drug resistance in plasma and vaginal fluids. The broken line denotes the limit of quantitation of the virus load assay (50 copies/ml).

    No evidence of emerging drug resistance after continued gel dosing in breakthrough infections

    Because L-812 and RAL were detected in plasma in the breakthrough infections, it was important to determine whether these systemic drug exposures led to drug resistance. Sequence analysis of the integrase region spanning the N-terminal and core domain (amino acids 1 to 234) in virus first detected in plasma showed that both breakthrough infections were initiated with wild-type virus (fig. S1). Plasma specimens collected at peak viremia and up to 8 weeks after infection all revealed wild-type genotypes (Fig. 5A). To examine drug resistance emergence at the site of gel application, we also genotyped SHIV RNA isolated from vaginal secretions in the RAL breakthrough infection (fig. S1). Vaginal fluids with detectable SHIV (n = 4) were genotyped, and all found to be wild type (Fig. 5B). Thus, despite twice-weekly vaginal dosing for 8 weeks after infection, no evidence of drug resistance in plasma or genital secretions was observed (fig. S1).


    This study provides a proof of concept that topically applied strand transfer integrase inhibitors protect macaques against repeated vaginal SHIV challenges. Protection was observed when the vaginal gel was applied shortly before and, more importantly, 3 hours after virus challenge. The protection by postexposure dosing reflects the advantages of the late-acting strand transfer inhibitors that are needed several hours after virus entry, thus providing an optimal window for post-coital dosing that was previously not feasible with entry or RT inhibitors (8, 9). Because applying gel after sex may interfere less with sexual practices, our data support exploring new post-coital modalities with integrase inhibitors for enhanced acceptance and compliance in women.

    We used single-round infections to determine the kinetics of reverse transcription and integration and show that in the HeLa-derived TZM-bl cells, strand transfer starts more than 6 hours after infection, consistent with previous findings in different cell infection systems (21, 22, 26, 27). The integration step may take longer in less activated primary cells that are commonly present in vivo in which reverse transcription and integration proceed more slowly than in transformed cell lines (26, 28). Thus, it is likely that the dosing window in vivo may be longer than the 3 hours evaluated in this study. Integrase inhibitors, including RAL, are known to bind tightly to preintegration complexes with dissociation half-lives of >7 hours, which ensures longer antiviral activity in infected cells even if tissue drug concentrations subsequently decay to suboptimal levels (19). We also note the detection of drug in plasma within 30 min of vaginal gel dosing, which reflects rapid absorption through vaginal tissues. The rapid absorption of RAL and the lack of intracellular activation suggest that the pharmacological lag time for in vivo activity may be minimal. Additional macaque studies of longer postexposure gel applications are needed to further define the post-coital window of protection by strand transfer inhibitors.

    We also document in pigtailed macaques changes in plasma drug levels during the menstrual cycle and observe higher concentrations during the progesterone-dominated luteal phase. These results reflect a higher vaginal permeability peaking during the luteal phase likely due to thinner epithelium, increased porosity, changes in mucus composition, and other factors (23, 24, 29). The influence of the menstrual cycle on vaginal drug absorption also explains the cyclical changes in plasma concentrations of TFV and FTC we have previously observed in pigtailed macaques dosed with gels containing TFV and FTC (6). We also examined the relationship between plasma drug concentrations and vaginal efficacy because Cranage et al. previously found a positive association between TFV concentration in plasma and the degree of rectal protection by rectal TFV gel (9). With only two breakthrough infections, we were unable to discern any trend because one animal had high drug concentrations around the estimated time of infection and one did not. These results likely highlight the added complexity in identifying pharmacological markers of vaginal protection relative to rectal protection and the confounding role of the menstrual cycle modulating both susceptibility to infection and drug permeability (23). Nevertheless, the data show the usefulness of the pigtailed macaque model that has a menstrual cycle similar to that of women, and support similar evaluations in women to better define the impact of menstrual cycle and hormonal contraceptives on vaginal pharmacokinetic parameters and efficacy.

    Both L-812 and RAL are potent drugs with IC50 in nanomoles; however, we found that the concentrations in gels that conferred high, yet incomplete, in vivo protection were in the micromolar range, or about 1 million–fold higher than those concentrations needed for in vitro inhibition. The higher drug concentrations required for in vivo efficacy have been consistently observed with other gels containing entry or RT inhibitors and likely reflect the distribution kinetics of the drug through the mucosa to achieve concentrations needed to protect the large surface area of the vagina for a significant period of time (6, 7, 10). Previous work with TFV gels in macaques has shown that the pharmacologically active TFV-diphosphate (TFV-DP) concentrations in vaginal lymphocytes predict in vivo efficacy, and topical dosing by gel or intravaginal ring that achieved TFV-DP concentrations exceeding the in vitro IC95 values in these lymphocytes was associated with complete protection (10, 30). Thus, it is tempting to surmise that a similar pharmacological correlate will also apply to RAL. However, confirming this correlate will require measuring intracellular RAL concentrations in vaginal lymphocytes, which could be challenging because unlike intracellularly bound TFV-DP, RAL may diffuse out during the cell purification process as extracellular RAL concentrations decrease. Thus, alternative tissue testing methods are needed.

    The potential for drug resistance to develop when prophylaxis fails raises concerns, especially with drugs that are also used for treatment. Prolonged systemic treatment of SHIV-infected macaques with L-812 has been found to select drug-resistant variants with the integrase mutation (N155H) (20). We show no evidence of drug resistance emergence in plasma from either the L-812 or RAL breakthrough infection despite continued twice-weekly gel dosing for up to 8 weeks after infection. Although larger numbers of animals are needed to define incidence of resistance in animals failing prophylaxis, the finding of wild-type SHIV suggests that both gel failures are not due to a selection of a low-frequency drug-resistant variant in the challenge virus, and likely reflects insufficient selective pressure by the systemically absorbed drug from the twice-weekly gels. These systemic drug exposures are much lower than those observed from oral dosing and likely contribute to lower risks of drug resistance (20). Indeed, we found no reduction in the acute viremia in both breakthrough infections compared to controls, further supporting the minimal systemic antiviral activity. These findings are similar to TFV gel breakthrough infections but differ from those in macaques that fail oral PrEP in which reductions in virus loads and selection of drug-resistant variants have been observed (7, 9). Given that the antiviral activity from gels remains largely concentrated in the vaginal compartment, we also evaluated the viral population in the genital secretions from the RAL breakthrough infection. We detected only wild-type SHIV, but noted that, in contrast to plasma virus load, vaginal virus shedding was substantially reduced in this macaque. The suppression of virus shedding may reflect the antiviral activity from gel dosing, which may also have reduced drug resistance selection. These data are only from one animal and require confirmation, but they do point to broader implications because reductions in vaginal virus shedding during acute infection may lower transmissibility.

    Our study has several limitations. The virus challenges did not include cell-associated virus and were done in the absence of semen or semen-derived factors shown to enhance HIV infection in vitro (18). However, recent data suggest little impact of semen on vaginal SIV transmission in rhesus macaques (31). Also, SHIV exposures were made on intact vaginal mucosa without trauma associated with coitus, concurrent genital ulcers, or bacterial vaginosis, all of which can increase the risk of HIV acquisition (26, 27). As previously noted, only two breakthrough infections were available to study vaginal SHIV shedding and drug resistance, and thus, these observations require confirmation in larger numbers of animals.

    In conclusion, we show preclinical in vivo data that support the use of topical integrase inhibitors for HIV prevention. We highlight the advantage of using this class of drugs in new post-coital modalities that were previously not possible with entry or RT inhibitors. This study supports evaluation of this class of drug for HIV prevention, including small molecules that do not overlap with clinically approved integrase inhibitors in optimized gels or other dosage forms such as vaginal rings or tablets (28, 32, 33). The study also supports further evaluation of post-coital modalities in women for enhanced acceptability and compliance.

    MATERIALS AND METHODS Gel formulations

    L-812 and RAL were provided by Merck and the National Institutes of Health (NIH) AIDS Research and Reference Reagent Program, respectively. L-812 was formulated at 0.23% (w/w) in a 2% HEC gel containing 20% propylene glycol, 0.02% propylparaben, 0.18% methylparaben, and 0.02% EDTA. RAL was formulated at 1% (w/w) in a 2% HEC gel containing 0.017 M phosphate-buffered saline (PBS) (pH 7.4), 0.02% propylparaben, 0.18% methylparaben, and 0.02% EDTA. A 2% HEC gel formulated without drug was used as a placebo control. Gels were stored at room temperature, and antiviral activity was confirmed throughout the course of the study with a TZM-bl reporter assay to measure drug susceptibility.

    Virus stock

    SHIVSF162P3 (SIVmac239 backbone with an HIV-1 subtype B, CCR5-tropic envelope) was obtained from the NIH AIDS Research and Reference Reagent Program and was propagated in peripheral blood mononuclear cells (PBMCs) from pigtailed macaques as previously described (34, 35). The virus stock titer was calculated in pigtailed macaque PBMCs and diluted to the challenge dose of 10 TCID50 (median tissue culture infectious dose) (1.5 × 106 RNA copies per exposure).

    Antiviral activity and stability of RAL gel

    TZM-bl cells (NIH AIDS Research and Reference Reagent Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH) were used to determine the IC50 of gels containing integrase inhibitors, and data were analyzed by GraphPad Prism (v5.02) software. For stability testing, 1% RAL gel (20 mM) was diluted 10-fold in PBS or macaque CVF and incubated overnight at 37°C. RAL-saline and RAL-CVF were then serially diluted (20-0 μM) in complete medium, and 100 μl was added to wells of a 96-well plate in triplicate. Complete medium (50 μl) containing TZM-bl cells (3 × 106/ml) was plated in each well. After 15 min of incubation, 50 μl of SHIVSF162p3 stock, diluted to a final concentration resulting in a signal of about 105 relative light units, was added to each well. After 48 hours of incubation at 37°C, 100 μl of medium was removed and replaced with 100 μl of Bright-Glo (Promega Corp.), and the luminescence was measured with PerkinElmer Victor X2 Multilabel Plate Reader. Inhibition was determined on the basis of reduction from the virus-only control and presented as the percentage of cells protected (mean ± SEM).

    Kinetics of postexposure inhibition

    Time-of-drug addition experiments were carried out with single-cycle infections to determine the inhibition window for RT and integrase inhibitors. TFV or RAL was added to infected TZM-bl cells at concentrations exceeding IC99 (200 μM TFV or 20 μM RAL) at different times after infection (0 to 24 hours). Briefly, TZM-bl cells were preincubated with VSV-pseudotyped HIV-1 NL4-3-ΔE-EGFP (VSV-HIV) for 1 hour to establish infection. A VSV-pseudotyped virus was used to ensure that all reported infectivity was derived from a single round of infection. Cells were washed twice with PBS and treated with 0.25% trypsin (Cellgro) to remove all cell-bound and cell-free viruses. Infected cells were resuspended in complete medium and plated (3 × 104 per well) in triplicates in a 96-well plate. Drug was added at 1-hour time increments up to 24 hours. The percentage of cells protected at each time point was determined and plotted as % cells protected ± SEM relative to time when drug was added after infection.

    Efficacy studies

    The efficacy of integrase inhibitors against vaginal transmission was evaluated in female pigtailed macaques under conditions similar to those described in other studies (6, 10). Macaques were administered gel (3 ml) vaginally and challenged with a low-dose SHIVSF162P3 inoculum (10 TCID50) twice weekly (every 3 to 4 days) for up to 10 weeks (about two menstrual cycles). All animals were anesthetized and remained recumbent for 30 min after each gel application and 15 min after virus inoculation to minimize leakage. For preexposure efficacy measurements, macaques received placebo (n = 1) or 0.23% L-812 (n = 3) gel vaginally 30 min before each vaginal SHIV exposure (up to 14 challenges). For postexposure efficacy, anesthetized animals were challenged with SHIV (up to 20 challenges) and remained incumbent for 15 min after receiving the virus to minimize leakage and then returned to their cages. After 3 hours, macaques were anesthetized and administered 3 ml of placebo (n = 4) or 1% RAL (n = 6) gel. For each study, blood was collected 30 min after gel dosing to monitor for drug levels and SHIV infection. Virus challenges were stopped when a macaque became SHIV RNA-positive (SHIV+) in plasma. All infected macaques continued to receive study gel (placebo, L-812, or RAL) twice weekly for up to 8 weeks after infection. All experiments were done under highly controlled conditions by the same personnel with the same virus stock, inoculum dose, and procedures as described in previous studies (6). These studies adhered to the Guide for the Care and Use of Laboratory Animals (Institute for Laboratory Animal Research, 1996); all procedures were approved by the Institutional Animal Care and Use Committees of both the Centers for Disease Control and Prevention (CDC) and the Yerkes National Primate Research Center, Emory University.

    Monitoring systemic infection, virus shedding, and drug resistance

    Systemic infection was monitored twice weekly by screening for SHIV RNA in plasma with a quantitative real-time reverse transcription polymerase chain reaction (PCR) assay with a sensitivity of 50 RNA copies/ml, as previously described (6, 34, 36). The estimated time of infection was defined as 7 to 10 days before the first SHIV-positive specimen to account for the eclipse period between infection and detection of SHIV RNA in plasma. Infected macaques were monitored for emergence of drug resistance in both plasma and CVF by standard sequence analysis of SIVmac239 integrase reference sequence base pairs 3624 to 4332 (amino acids 1 to 234). CVF specimens were collected by instilling and recollecting about 5 ml of sterile PBS in the vaginal cavity. CVFs were centrifuged for 15 min at 400g to pellet cells and debris. Virion-associated RNA was extracted from CVF supernatant (1 ml) with a Qiagen viral RNA kit. PCR amplification of PBMC proviral DNA was done with primers and probes specific for SIVmac239 pol (6, 34). Serologic testing was performed with a synthetic peptide enzyme immunoassay (Genetic Systems HIV-1/HIV-2 Plus O; Bio-Rad). Animals were considered protected if they tested negative for SHIV RNA in plasma and SHIV DNA in PBMCs and remained seronegative during the challenge period of the study and the 10-week follow-up in the absence of challenge and gel application.

    Measurement of drug concentrations in plasma

    L-812 and RAL levels in plasma were measured in macaques 30 min after vaginal administration of 0.2% L-812 and 1% RAL gel, respectively. Briefly, drug was extracted from 100 μl of plasma by protein precipitation with 350 μl of methanol containing 200 ng of the unstudied analyte as the internal standard (RAL was used as an internal standard for L-812 and vice versa). Supernatant containing the drug from precipitation was evaporated to near dryness under vacuum and then resuspended in high-performance liquid chromatography (HPLC) buffer A (9.9 mM acetic acid, 5.9 mM ammonium hydroxide, and 9.4 mM formic acid in H2O). Drug concentrations were analyzed by HPLC–tandem mass spectrometry method with a Shimadzu Prominence HPLC (Shimadzu Scientific) system equipped with a 150 × 2.0–mm Ascentis Phenyl column (Sigma-Aldrich) and an AB Sciex 3200 QTRAP mass spectrometer. Chromatography was done with a linear gradient of 20 to 90% buffer B (acetonitrile containing 9.9 mM acetic acid, 5.9 mM ammonium hydroxide, and 9.4 mM formic acid). Mass spectrometer was run in positive MRM (multiple reaction monitoring) mode, and the following transitions were monitored: for RAL, mass/charge ratio (m/z) 445.2/109.0 and 445.2/361.5, and for L-812, m/z 354.1/109.0 and 354.1/203.0. The assay had a lower limit of quantification of 5 ng/ml for both analytes and standard curve R2 values greater than 0.99.

    Menstrual cycle and drug absorption monitoring

    A longitudinal assessment of drug absorption in relation to menstrual cycle was done by measuring plasma drug and progesterone levels 30 min after vaginal gel application throughout the challenge period for each animal and each cycle. Plasma samples collected twice per week (every 3 to 4 days) were analyzed for drug levels as described above, and progesterone levels were measured at the University of Wisconsin National Primate Research Center with an enzyme immunoassay (37).

    Statistical methods

    Fisher’s exact test was used to compare the number of infections per number of months at risk by study group. Risk for infection per month, or approximately per menstrual cycle, with biweekly challenge doses throughout each month, considers that cycling pigtailed macaques are more susceptible to infection during the luteal phase of the menstrual cycle as previously demonstrated in this model (23). Intervention efficacy was calculated as 1 − (p1/p0), where p1 and p0 denote the proportion of months with incident infection for intervention and control animals, respectively (38). SAS version 9.2.1 or GraphPad Prism 5 for Windows (GraphPad Software, was used for all statistical analyses.

  • The VOICE Study (MTN-003) (2013).

  • J. Marrazzo, G. Ramjee, G. Nair, T. Palanee, B. Mkhize, C. Nakabiito, M. Taljaard, J. Piper, K. Gomez, M. Chirenje, Pre-exposure prophylaxis for HIV in women: Daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003), paper presented at the 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, 3 to 6 March 2013.

  • C. Dobard, S. Sharma, Impact of Depo-Provera and menstrual cycle on vaginal absorption of antiretroviral drugs from gels in pigtail macaques, paper presented at the 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, 3 to 6 March 2013.

  • Acknowledgments: We thank S. Ehnert, C. Souder, E. Strobert, and the animal care staff at the Yerkes National Primate Center (Emory University) as well as J. Mitchell, E. Sweeney, and S. Bachman at the CDC for monitoring, maintaining, and performing animal procedures using our macaque cohort. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the CDC. Use of trade names is for identification purposes only and does not constitute endorsement by the U.S. CDC or the Department of Health and Human Services. Funding: Partially supported by Interagency Agreement Y1-AI-0681-02 between CDC and NIH. Author contributions: C.D., F.N., J.S., D.H., J.G.G.-L., and W.H. designed the research. C.D. and S.S. executed the macaque studies. C.D., S.S., U.M.P., R.W., and A.T. performed in vitro experiments and provided assistance in processing macaque samples and data analysis. J.L. performed drug resistance testing. A.M. and C.-P.P. performed drug analysis. D.L.H. performed statistical analyses. D.H. provided drug. C.D. and W.H. wrote the manuscript. Competing interests: W.H. and J.G.G.-L. are named on patent application 11/669,547 filed by the U.S. government entitled “Inhibition of HIV infection through chemoprophylaxis.” The authors declare that they have no competing interests.

  • The Morning Download: Estonia CIO Works to Help Create National AI Policy | real questions and Pass4sure dumps

    Good day, CIOs. Estonia’s tech-savvy population has helped transform the country into an innovation hub, with the tiny Baltic nation hitting above its weight in launching startups. Similarly, Estonia’s geographical location has propelled the government’s approach to technology. Estonia is a leader in cybersecurity, but also blockchain and e-citizenship, a digital-first approach to sovereignty that makes sense when Russia is your neighbor. Now Estonia is working toward a national policy concerning artificial intelligence. CIO Journal’s Sara Castellanos talks with Siim Sikkut, Estonia’s chief information officer, about the effort.

    A national AI action plan. “We could just tinker around without having a coordinated, coherent plan,” said Mr. Sikkut. “But if you want to make a concentrated effort and move strong and fast, you need to figure out what to put in motion, (what) barriers to break, and that’s what the plan gives us.” Estonia’s upcoming action plan will address issues such as the extent to which government should use AI without being overly reliant on the technology or intruding on privacy, Mr. Sikkut said.

    A small club. The country, with a population of about 1.3 million, will join several others that have developed national strategies to promote the use and development of AI, including China, Finland, Canada, France and Germany. Guidelines for how to deploy AI, and to what extent, will be critical for governments seeking to maximize their relevance in the new global economy,  said Keith Strier, EY's global and Americas artificial intelligence leader and the lead partner and senior advisor on the project with Estonia. “Not having a national AI action plan will mean a failure to really coordinated focused resources, which, in a smaller country is more essential because there’s more limited resources.”


    What happens in Vegas (goes to the cloud). Inc.'s cloud unit unveiled a number of goodies at its annual event in Las Vegas, Among them:

    VMware-enabled hardware for hybrid cloud users to use in their own data centers through a service called AWS Outposts. (GeekWire).

    Its own server chips, called Graviton, built on the ARM architecture used in smartphone chips. (Wired), and a machine learning chip, Inferentia. (Reuters)

    A managed blockchain offering and Amazon Quantum Ledger Database, "where customers can replicate a copy of their blockchain network activity." (CNBC)

    A Windows-compatible service targeting potential Azure users. (Bloomberg)

    A remote-controlled car that can be trained using re-enforced learning. (Business Insider)

    Facebook emails reveal discussion on monetizing user data. Internal emails, most from 2012 to 2104, show that Facebook Inc. considered charging companies for continued access to user data several years ago. The emails also indicate that Facebook employees discussed pushing some advertisers to spend more in return for increased access to user information. Writes Journal's Deepa Seetharaman: "Taken together, the internal emails show the company discussing how to monetize its user data in ways that are employed by some other tech firms but that Facebook has said it doesn’t do."

    Amazon makes inroads selling medical supplies to the sick. A growing number of doctors around the U.S. can direct a patient to Inc. for medical products via an app embedded in the patient’s private medical record, the WSJ's Melanie Evans reports. Hospitals say the goal is to replace the handwritten shopping lists doctors often hand people. But privacy experts express concern that patients could unwittingly share personal and potentially sensitive health information with Amazon. Federal health-privacy law, enacted in 1996, was never intended to address patients unwittingly sharing sensitive medical data while shopping online, privacy lawyers say.

    Microsoft wins $480 million AR Army contract. Microsoft Corp.will supply prototypes of its augmented reality headsets to the U.S. Army. But these are not your ordinary gaming models. The headsets could include night vision, thermal sensing and hearing protection. Ultimately the Army could end up purchasing up to 100,000 customized HoloLens devices, Bloomberg says.

    North Sea oil blockchain platform goes live. Hopes are Vakt, created in by a consortium that includes oil majors Royal Dutch Shell, BP and Norway’s Equinor, will replace paperwork associated with finalizing oil deals between the players, Reuters reports. The blockchain platform plans to expand to include crude U.S. pipelines in 2019.

    Justice indict hackers in Atlanta hack. The Justice Department Wednesday indicted two Iranians for a ransomware attack earlier this year that crippled Atlanta’s government for days, the New York Times reports. The men, Faramarz Shahi Savandi and Mohammad Mehdi Shah Mansouri, are credited with creating SamSam, ransomware employed against a number of public agencies over the last couple years, including the city of Newark and the Port of San Diego and a number of hospitals.

    Dell resets customer passwords. Nearly a week after detecting and stopping an attempt by hackers to steal customer data, Dell Technologies Inc. said Tuesday it would reset passwords for all of its online store customers, Reuters reports.

    Musk scraps West LA tunnel. The Boring Company, Elon Musk's underground transportation venture, will cease work on its tunnel on LA's west side after encountering resistance from community groups, Reuters said. But its work on a high speed passenger tunnel between Dodger Stadium and nearby subway stops will continue.

    Hello? Is it me you're looking for? As companies compete for workers in the tightest labor market in decades, more employers are rethinking the tried-and-true phone interview, rolling out one-sided, automated exchanges in which applicants give recorded responses to a series of questions. The WSJ's Chip Cutter has more on the latest sign of the apocalypse.

    Amazon store comes to NYC's SoHo. "Spending time browsing here was among my most dismal shopping experiences in recent memory," the New York Times writes. "And that was before a 20-something guy bounded into the store and started screaming: 'Alexa! Alexa! Alexa!'"


    Trump administration duties have scrambled the global steel trade, with countries that can no longer sell into the U.S. sending their products into Europe at a record rate. (WSJ)

    Renault, Nissan and Mitsubishi are “fully committed” to their global auto alliance, as top executives gathered for the first meeting of the partnership since the arrest last week of its prime architect, Carlos Ghosn. (WSJ)

    Deutsche Bank offices were searched by police and prosecutors seeking evidence in connection with alleged money laundering, the Frankfurt prosecutor’s office said. (WSJ)

    Oil prices were hit by another wave of heavy selling, with fears of climbing production dragging the two most popular benchmarks to lows not seen in more than a year. (WSJ)

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