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Kaletra (lopinavir/ritonavir) Product Labeling was Updated (6-30-2015)

Posted June 30, 2015

The Kaletra (lopinavir/ritonavir) product labeling was updated to include drug-drug interaction information with etravirine, rilpivirine and simeprevir and to update the Use in Specific Populations, Pediatric Use subsection with information from a clinical trial that investigated the use of a once daily dosing regimen. The specific changes to the product labeling are summarized below.

The following additions were made to section 7 Drug Interactions, Table 13. Section 12.3 Clinical Pharmacology, Table 14 and 15 was updated to provide the results of the etravirine and rilpivirine drug-drug interaction trials.

  • The clinical comment for use with etravirine states: Because the reduction in the mean systemic exposures of etravirine in the presence of lopinavir/ritonavir is similar to the reduction in mean systemic exposures of etravirine in the presence of darunavir/ritonavir, no dose adjustment is required.
  • No dose adjustment is required with rilpivirine
  • Co-administration of Kaletra and simeprevir is not recommended

Section  8.4 Pediatric Use was updated to include the results of a once daily versus twice daily dosing trial as summarized below.

The safety, efficacy, and pharmacokinetic profiles of KALETRA in pediatric patients below the age of 14 days have not been established. KALETRA should not be administered once daily in pediatric patients.

A prospective multicenter, randomized, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of KALETRA tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173). Children were eligible when they were aged < 18 years, ≥ 15 kg in weight, receiving cART that included KALETRA, HIV-1 ribonucleic acid (RNA) < 50 copies/mL for at least 24 weeks and able to swallow tablets. At week 24, efficacy (defined as the proportion of subjects with plasma HIV-1 RNA less than 50 copies per mL) was significantly higher in subjects receiving twice daily dosing compared to subjects receiving once daily dosing. The safety profile was similar between the two treatment arms although there was a greater incidence of diarrhea in the once daily treated subjects.

You can view the complete label at drugs@fda or dailymed.

 

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Medicaid Update: June (6-29-2015)

Posted June 29, 2015

Dear Medicaid Provider,

The Office of Health Insurance Programs of the New York State Department of Health has approved the release of the June 2015 Medicaid Update.

Please click the link below to download the current edition.

http://www.health.ny.gov/health_care/medicaid/program/update/2015/jun15_mu.pdf (PDF)

To see a list of all of the 2015 DOH Medicaid Updates, please visit http://www.health.ny.gov/health_care/medicaid/program/update/2015/index.htm

 

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NYS Clinical Education: New CME Courses (6-23-2015)

Posted June 23, 2015

New CME Courses

The Clinical Education Initiative is pleased to announce the availability of three new CME courses. All courses are free and can be taken online at any time.

Please visit https://www.ceitraining.org/sp2/ today to sign-up for these training opportunities.

For more information, please visit http://www.ceitraining.org/

 

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NYC DOHMH Advisory: Update On Ebola Viral Disease (06-19-2015)

Posted June 19, 2015

2015 DOHMH Advisory #13: Update On Ebola Viral Disease – Evaluating and Public Health Monitoring of Travelers from Liberia

  • Ebola viral disease (EVD) outbreaks continue in Guinea and Sierra Leone; Liberia was declared Ebola-free on May 9th
    • Providers should continue to rapidly identify, isolate, assess and immediately report any travelers who present with symptoms consistent with EVD within 21 days of their departure from either Guinea or Sierra Leone.
    • Travelers from Liberia will no longer be monitored by the Health Department and no longer need to be evaluated and managed as having suspected EVD unless they also traveled to Guinea or Sierra Leone within 21 days of illness onset.
    • Travelers who only were in Liberia should be evaluated for other causes of travel-related illness
  • Always collect a travel history on patients presenting with febrile illness and remain aware of current outbreaks overseas.

Please click here to view the complete Dear Colleague Advisory Letter from the New York City Department of Health and Mental Hygiene.

Please click here to view the official CDC Health Advisory.

 

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New Medscape Commentary: AI's PEP Guideline Updates (6-17-2015)

Posted June 17, 2015

Every few months Medscape features a New York State Department of Health AIDS Institute guideline along with commentary written by clinicians who work with the HIV Clinical Guidelines Program.

The most recent guideline to be featured on Medscape are a set of 3 on Post-Exposure Prophylaxis with commentary written by Dr Samuel T Merrick.

To view the commentary on Medscape, please click on the following link: http://www.medscape.com/viewarticle/846532

To see the full series of hivguidelines that have posted on Medscape so far, please visit the Medscape website at: http://www.medscape.com/index/section_10155_0

Medscape Commentary Archives

 

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NYC DOHMH Advisory: Tick-borne Disease (06-17-2015)

Posted June 17, 2015

2015 DOHMH Advisory #12: Tick-borne Disease Advisory

  • The following tick-borne diseases are reportable in New York City (NYC): Lyme disease, Rocky Mountain spotted fever (RMSF), babesiosis, ehrlichiosis and anaplasmosis.
    • All with the exception of RMSF are associated primarily with travel outside of NYC.
  • New and updated resources for tick-borne diseases are available on the DOHMH website.

Please click here to view the complete Dear Colleague Letter from the New York City Department of Health and Mental Hygiene.

 

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OMD AIDS Institute: Quick News Update (6-17-2015)

Posted June 17, 2015

QUICK NEWS UPDATE FROM OMD AIDS INSTITUTE – 6/17/15

    • UPDATED GUIDELINES on WHEN TO START ART and CD4/VL MONITORING have been posted here.

 

 

 

    • The NYS Division of Human Rights (DHR) has launched a statewide outreach campaign for HIV/AIDS service providers, advocacy groups, and PLWHA. For more information, click here.

 

    • The Healthcare Stories Project, an OMD sponsored program to engage consumers and providers in experience-based quality improvement processes and activities has launched it’s second activity- “How is Today’s Visit Going?” to capture patient experiences in real-time. Click here for more information.

 

 

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Letter from the AIDS Institute Director: Emerging Risk of Shigella for MSM (6-15-2015)

Posted June 15, 2015

Dear Colleague:

The Centers for Disease Control and Prevention (CDC) has announced further outbreaks and the continued rise of antibiotic resistant Shigella infectious diarrhea primarily affecting gay, bisexual and other men who have sex with men (collectively referred to as MSM) in the United States. The reported Shigella strains are not susceptible to ciprofloxacin and/or azithromycin, which are the principle therapies for shigellosis treatment.

Shigellosis is a diarrheal infection, ordinarily associated with day-care center outbreaks and foreign travel. The current alert underscores both the emerging risk of the MSM community to shigellosis and clinically the decreased effectiveness of standard ciprofloxacin and azithromycin antibiotic in shigellosis treatment.

Shigellosis Signs and Symptoms

Generally those are infected with Shigella will develop symptoms that commonly include: diarrhea, fever, stomach cramps and tenesmus (a painful sensation of needing to pass stools even when bowels are empty) starting a day or two after they are exposed to the bacteria. Shigellosis usually resolves in 5 to 7 days. Individuals who are infected may experience no symptoms at all, but may still be able to transmit the Shigella bacteria to others. There is no vaccine available for shigellosis, but the spread of Shigella can be stopped by frequent and careful handwashing with soap and taking other hygiene measures.

For More Information

General CDC guidance is available at: http://www.cdc.gov/shigella/index.html. Along with its General Prevention Recommendations of good hygiene, such as washing hands with soap before preparing food or eating and after using the toilet, the CDC provides specific recommendations for those at higher risk including the MSM community. This information is available at http://www.cdc.gov/shigella/msm.html.

Clinicians with questions regarding this information should contact the NYSDOH AIDS Institute Office of the Medical Director at 1-212-417-4536.

See also: New York City Health Department Alert, June 5, 2015 for a brief summary of local data.

Letter from the AIDS Institute Director: Emerging Risk of Shigella for MSM (PDF)

 

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LGBT Health and Human Services Network Survey (6-9-2015)

Posted June 9, 2015

The AIDS Institute is pleased to announce that the LGBT Health and Human Services Network is launching a survey to gather input from lesbian, gay, bisexual and transgender New Yorkers on their health and human service needs. The survey is the culmination of a needs assessment process that also included 22 focus groups with over 200 LGBT New Yorkers and service providers and follows a similar effort in 2009 (the results of which can be found here). We are hoping to encourage 5,000 New Yorkers to take the survey in June and July. It is particularly important that the survey reach the most marginalized people within LGBT communities, particularly transgender people, people of color and those living in rural areas. We ask for your help in promoting the survey.

If you have a listserv, web page or Facebook presence, please consider sending out the following message:

If you are 16 or older and identify as lesbian, gay, bisexual or transgender, we need to hear from you. Tell New York State what LGBT people need! Take this anonymous survey for a chance to win one of 20 $50 Amazon gift cards and make your voice heard.

Click to take the survey!

While we are encouraging people to take the survey online, there are also paper versions available. If you have questions, or to request promotional materials, please email: KLaSane@StrengthInNumbersConsulting.com. We hope that you will consider supporting this important effort.

 

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NYS Clinical Education: Last Call for Registration, NYS Provider Directory, HCV Cards (6-9-2015)

Posted June 9, 2015

LAST CALL for Registration: 2015 New York State STD Clinical Conference

Friday, June 19, 2015, Tarrytown, New York.

Because this is a clinical conference intended for licensed health professionals and because seating is limited, physicians, dentists, pharmacists, nurse practitioners, physician assistants, and nurses will receive priority for registration.

Interested health professionals should contact Thomas Della Porta, MS at 1.585.753.5379 or at thomas_dellaporta@urmc.rochester.edu for more information.

Please visit http://ceitraining.org/events/ to view all of our upcoming events.

New York State PrEP/PEP Provider Voluntary Directory

In an effort to increase access to HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), the New York State Department of Health AIDS Institute (NYSDOH AI) has compiled a list of providers that prescribe PrEP/PEP.

Please visit http://ceitraining.org/prepdir to learn more and join.

New Hepatitis C Cards

Don’t miss out on this valuable resource for the clinicians at your organization! This convenient card provides clinically relevant information on recommended screening guidelines, lab tests and monitoring, the CEI Line, as well as the website addresses for further guideline information and CEI initiatives.

Please visit the following link to view and order FREE HCV cards, as well as PrEP and PEP cards, for your organization: https://www.surveymonkey.com/r/BG38MH5

These cards are intended only for New York State clinicians including physicians, physician assistants, nurses, nurse practitioners, dentists, and pharmacists.

For more information, please visit http://www.ceitraining.org/

 

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CDC Advisory: Ciprofloxacin- and Azithromycin-Nonsusceptible Shigellosis in the United States (6-5-2015)

Posted June 5, 2015

The New York City (NYC) Health Department brings you this CDC Health Alert on ciprofloxacin- and azithromycin-nonsusceptible shigellosis in the United States. The NYC Health Department has also seen the emergence of resistant shigellosis in NYC and have included a brief summary of local data.

The NYC Public Health Laboratory performs antibiotic susceptibility testing on all Shigella isolates forwarded to our laboratory. No guidelines for antibiotic susceptibility testing are available for Shigella spp. and azithromycin. The NYC DOHMH used a minimum inhibitory concentration (MIC) > 32 µg/ml to define decreased susceptibility to azithromycin (DSA). (CDC defined azithromycin resistance as MIC > 16 µg/ml). From March 22, 2013- February 7, 2015, 729 isolates were tested and 100 (14%) demonstrated DSA, 23/729 (3%) had ciprofloxacin resistance and 4 (0.5%) isolates were resistant to both. Additionally, 482 (66%) and 418 (57%) isolates were resistant to ampicillin and trimethoprim/ sulphamethoxazole, respectively.

Among 100 Shigella isolates demonstrating DSA, 62 (62%) were from patients who were HIV positive based on a match with the DOHMH HIV registry; all HIV positive cases were male. Sixty-five (65%) patients infected with Shigella demonstrating DSA were interviewed, 24 (37%) reported being hospitalized. Although current NYC hospitalization rates for all patients with Shigella are not available, in 2006-2009 a similar group of patients had an 18% hospitalization rate.

Most Shigella infections are self-limited; however, patients with underlying medical illnesses, the very young and the elderly may be susceptible to severe infections. Providers are urged not to treat infections in otherwise healthy patients. When treatment is necessary however, providers should use antibiogram information to guide antibiotic choices. Among the 65 NYC patients infected with Shigella demonstrating DSA, 10 (15%) were prescribed antibiotics to which the isolate was not susceptible. As azithromycin resistance testing is not generally clinically available, providers choosing azithromycin for treatment should be aware of the high incidence of resistance to this drug (and other antibiotics) in Shigella isolates especially among HIV positive patients, and monitor clinical response.

More general information on resistant shigellosis is included in the CDC alert below. If you have any questions or concerns about resistant shigellosis, please call the NYC Provider Access Line at 866-692-3641.

To read the official CDC Health Advisory, please click here.

 

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CDC Releases Sexually Transmitted Diseases Treatment Guidelines, 2015 (6-4-2015)

Posted June 4, 2015

The U.S. Centers for Disease Control and Prevention (CDC) published its updated Sexually Transmitted Diseases Treatment Guidelines, 2015, in the Morbidity and Mortality Weekly Report, Recommendations and Reports. With more than 20 million cases of STDs occurring in the United States each year, it is critical for healthcare providers to have access to scientifically-sound, evidence-based diagnostic, treatment, and prevention recommendations to help reduce the burden of these infections.

 

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Email Announcement Archives

The HIV Clinical Guidelines Program provides subscribers with email announcements of when new guidelines are posted and existing guidelines are updated.

hivguidelines email announcement archives

hivguidelines Trends, Topics & Updates monthly mailer archives

Subscribe to hivguidelines email announcements

 

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