Posts filed under ‘GUIDELINES’

2015-04 Guidelines for the Use of ARVs Agents in HIV-1-Infected Adults and Adolescents DHHS

2015-04 Guidelines for the Use of ARVs Agents in HIV-1-Infected Adults and Adolescents DHHS

Developed by the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC)

What’s New in the Guidelines?

(Last updated April 8, 2015; last reviewed April 8, 2015)

Revisions to the May 1, 2014, version of the guidelines include key updates to several existing sections and the addition of two new tables. Significant updates are highlighted throughout the document.

Key Updates

The following are key updates to existing sections of the guidelines.

What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient

Since the last version of these guidelines, data from clinical trials and cohort studies, as well as experience in clinical practice, have prompted significant changes to the list of Recommended, Alternative, and Other regimens for treatment-naive patients (Table 6). Additionally, a new table, titled “Antiretroviral (ARV)

Regimen Considerations as Initial Therapy Based on Specific Clinical Scenarios,” has been created to guide clinicians on the selection of an initial ARV regimen based on specific clinical scenarios and ARV-related considerations (Table 7).

 

  • There are now five Recommended regimens for antiretroviral therapy (ART)-naive patients—four integrase strand transfer inhibitor (INSTI)-based regimens and one ritonavir-boosted protease inhibitor (PI/r)-based regimen, as listed below:

 

  INSTI-Based Regimens:

  • Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC)—only for patients who are HLA-B*5701 negative (AI)
  • DTG plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (AI)
  • Elvitegravir/cobicistat/TDF/FTC (EVG/c/TDF/FTC)—only for patients with pre-ART CrCl >70 mL/min (AI)
  • Raltegravir (RAL) plus TDF/FTC (AI)

 

PI/r-Based Regimen:

  • Darunavir/ritonavir (DRV/r) plus TDF/FTC (AI)

 

  • Two regimens previously classified as Recommended regimens have been moved to the Alternative regimens category, with the rationale stated below:

 

  • Atazanavir/ritonavir (ATV/r) plus TDF/FTC (BI)—Based on the results of a large comparative clinical trial showing a greater rate of discontinuation with ATV/r plus TDF/FTC because of toxicities when compared to (DRV/r or RAL) plus TDF/FTC

 

  • Efavirenz/TDF/FTC (EFV/TDF/FTC) (BI)—Based on concerns about the tolerability of EFV in clinical trials and practice, especially the high rate of central nervous system (CNS)-related toxicities and a possible association with suicidality

 

  • Three regimens (ATV/r plus ABC/3TC, EFV plus ABC/3TC, and rilpivirine/TDF/FTC) that were previously listed as Recommended regimens for baseline HIV RNA <100,000 copies/mL or CD4 T lymphocyte (CD4) count >200 cells/mm3 are now in the Alternative or Other category, with the same caveat about limiting their use in these populations.

 

  • Two regimens that use fewer than two nucleoside reverse transcriptase inhibitors (DRV/r plus RAL and lopinavir/ritonavir plus 3TC) are now listed among the Other regimens, with the caveat that their use would be limited to those patients who cannot take either TDF or ABC.

 

  • Coformulations of atazanavir (ATV) and darunavir (DRV) with the pharmacokinetic (PK) enhancer cobicistat (COBI) have been added to the Alternative regimen options.

 

Virologic Failure

The following key updates have been made to this section:

 

  • The Management of Virologic Failure in Different Clinical Scenarios subsection has been expanded to provide guidance on the management of patients failing first and second ART regimens.

 

  • A new subsection on Isolated CNS Virologic Failure and New Onset Neurologic Symptoms has been added.

 

  • The Suboptimal Immunologic Response Despite Viral Suppression subsection has been moved from this section to become a stand-alone section (see below).

 

Poor CD4 Cell Recovery and Persistent Inflammation Despite Viral Suppression

  • This new section describes the role of persistently low CD4 cell count (<200 cells/mm3) and persistent inflammation/immune activation on the increased risk of AIDS- and non-AIDS-related morbidity.

 

  • The Panel emphasizes that currently no therapeutic intervention designed to improve CD4 cell recovery or immune activation has been proven to improve health.

 

Acute/Early HIV Infection

  • This section has been updated to include the 2014 Centers for Disease Control and Prevention’s recommendation for diagnosis of HIV infection, including in individuals with acute/early HIV infection.

 

HIV-2 Infection

  • This section has been updated with the most recent literature on ARV use in HIV-2-infected patients.

 

HIV/Hepatitis C Virus (HCV) Coinfection

  • The text and table (Table 12) in this section have been updated with information on the concomitant use of different ARV drugs with the new HCV drug combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir.

 

Drug Interaction

  • The text of this section has been updated to focus on mechanisms of interaction of ARV drugs.

 

  • A new table, titled “Mechanisms of Antiretroviral Associated Drug Interactions,” has been developed to provide clinicians with information on clinically relevant mechanisms of PK-associated interactions for individual ARV drugs (Table 17).

 

  • All the Drug Interaction tables have been updated; in particular, interactions related to ATV/c, DRV/c, and EVG plus PI/r have been added to these tables (see Tables 19a–e, 20a, and 20b).

 

Additional Updates

Minor revisions have also been made to the following sections:

  • Discontinuation or Interruption of Antiretroviral Therapy
  • Exposure-Response Relationship and Therapeutic Drug Monitoring (TDM) for Antiretroviral Agents
  • Monthly Average Wholesale Price of Antiretroviral Drugs (Table 16)
  • Drug Characteristics tables (Appendix B, Tables 1–7)

 

PDF

http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf

– – –

April 14, 2015 at 12:38 pm

Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE)

Journal of Antimicrobial Chemotherapy Febreuary 2015 V.70 N.2 P.325-359

Jonathan A. T. Sandoe, Gavin Barlow, John B. Chambers, Michael Gammage, Achyut Guleri, Philip Howard, Ewan Olson, John D. Perry, Bernard D. Prendergast, Michael J. Spry, Richard P. Steeds, Muzahir H. Tayebjee, and Richard Watkin

1University of Leeds/Leeds Teaching Hospitals NHS Trust, Leeds, UK

2Hull and East Yorkshire Hospitals NHS Trust, Hull, UK

3Guy’s and St Thomas’ NHS Foundation Trust, London, UK

4University of Birmingham, Birmingham, UK

5Lancashire Cardiac Centre, Lancaster, UK

6Royal Infirmary of Edinburgh, Edinburgh, UK

7Freeman Hospital, Newcastle, UK

8Oxford University Hospitals NHS Trust, Oxford, UK

9Countess of Chester Hospital NHS Foundation Trust, Chester, UK

10University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

11Heart of England NHS Foundation Trust, Birmingham, UK

*Corresponding author. E-mail: jonathan.sandoe@nhs.net

Infections related to implantable cardiac electronic devices (ICEDs), including pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices, are increasing in incidence in the USA and are likely to increase in the UK, because more devices are being implanted.

These devices have both intravascular and extravascular components and infection can involve the generator, device leads and native cardiac structures or various combinations.

ICED infections can be life-threatening, particularly when associated with endocardial infection, and all-cause mortality of up to 35% has been reported. Like infective endocarditis, ICED infections can be difficult to diagnose and manage.

This guideline aims to

(i) improve the quality of care provided to patients with ICEDs,

(ii) provide an educational resource for all relevant healthcare professionals,

(iii) encourage a multidisciplinary approach to ICED infection management,

(iv) promote a standardized approach to the diagnosis, management, surveillance and prevention of ICED infection through pragmatic evidence-rated recommendations, and

(v) advise on future research projects/audit.

The guideline is intended to assist in the clinical care of patients with suspected or confirmed ICED infection in the UK, to inform local infection prevention and treatment policies and guidelines and to be used in the development of educational and training material by the relevant professional societies.

The questions covered by the guideline are presented at the beginning of each section.

PDF

http://jac.oxfordjournals.org/content/70/2/325.full.pdf+html

April 10, 2015 at 3:03 pm

Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices

MMWR Weekly March 27, 2015 V.64  N.11 P.300-304

Emiko Petrosky, MD, Joseph A. Bocchini Jr, MD, Susan Hariri, PhD, et al.

1Epidemic Intelligence Service, CDC; 2National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, CDC; 3Louisiana State University Health Sciences Center, Shreveport, Louisiana; 4National Center for Immunization and Respiratory Diseases, CDC; 5National Center for Chronic Disease Prevention and Health Promotion, CDC; 6National Center for Emerging and Zoonotic Infectious Diseases, CDC (Corresponding author: Emiko Petrosky, xfq7@cdc.gov, 404-639-1817)

During its February 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) (Gardasil 9, Merck and Co., Inc.) as one of three HPV vaccines that can be used for routine vaccination (Table 1).

HPV vaccine is recommended for routine vaccination at age 11 or 12 years (1). ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously.

Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously (1). 9vHPV is a noninfectious, virus-like particle (VLP) vaccine.

Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV contains HPV 6, 11, 16, and 18 VLPs. In addition, 9vHPV contains HPV 31, 33, 45, 52, and 58 VLPs (2). 9vHPV was approved by the Food and Drug Administration (FDA) on December 10, 2014, for use in females aged 9 through 26 years and males aged 9 through 15 years (3).

For these recommendations, ACIP reviewed additional data on 9vHPV in males aged 16 through 26 years (4). 9vHPV and 4vHPV are licensed for use in females and males. Bivalent HPV vaccine (2vHPV), which contains HPV 16, 18 VLPs, is licensed for use in females (1).

This report summarizes evidence considered by ACIP in recommending 9vHPV as one of three HPV vaccines that can be used for vaccination and provides recommendations for vaccine use….

FULL TEXT

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6411a3.htm?s_cid=mm6411a3_e

PDF See P.300-304

http://www.cdc.gov/mmwr/pdf/wk/mm6411.pdf

April 9, 2015 at 3:12 pm

SWAB/NVALT (Dutch Working Party on Antibiotic Policy and Dutch Association of Chest Physicians) guidelines on the management of community-acquired pneumonia in adults.

Neth J Med. 2012 Mar;70(2):90-101.

Wiersinga WJ1, Bonten MJ, Boersma WG, Jonkers RE, Aleva RM, Kullberg BJ, Schouten JA, Degener JE, Janknegt R, Verheij TJ, Sachs AP, Prins JM; Dutch Working Party on Antibiotic Policy; Dutch Association of Chest Physicians.

1Department of Internal Medicine, University of Amsterdam, Amsterdam, the Netherlands. w.j.wiersinga@amc.uva.nl

Abstract

The Dutch Working Party on Antibiotic Policy (SWAB) and the Dutch Association of Chest Physicians (NVALT) convened a joint committee to develop evidence-based guidelines on the diagnosis and treatment of community acquired pneumonia (CAP).

The guidelines are intended for adult patients with CAP who present at the hospital and are treated as outpatients as well as for hospitalised patients up to 72 hours after admission.

Areas covered include current patterns of epidemiology and antibiotic resistance of causative agents of CAP in the Netherlands, the possibility to predict the causative agent of CAP on the basis of clinical data at first presentation, risk factors associated with specific pathogens, the importance of the severity of disease upon presentation for choice of initial treatment, the role of rapid diagnostic tests in treatment decisions, the optimal initial empiric treatment and treatment when a specific pathogen has been identified, the timeframe in which the first dose of antibiotics should be given, optimal duration of antibiotic treatment and antibiotic switch from the intravenous to the oral route.

Additional recommendations are made on the role of radiological investigations in the diagnostic work-up of patients with a clinical suspicion of CAP, on the potential benefit of adjunctive immunotherapy, and on the policy for patients with parapneumonic effusions.

PDF

http://www.njmonline.nl/getpdf.php?id=1155

April 5, 2015 at 9:55 pm

BTS guidelines for the management of community acquired pneumonia in adults: update 2009.

Thorax. 2009 Oct;64 Suppl 3:iii1-55.

Lim WS1, Baudouin SV, George RC, Hill AT, Jamieson C, Le Jeune I, Macfarlane JT, Read RC, Roberts HJ, Levy ML, Wani M, Woodhead MA; Pneumonia Guidelines Committee of the BTS Standards of Care Committee.

Collaborators (36)

Author information

1Respiratory Medicine, Nottingham University Hospitals, David Evans Building, Hucknall Road, Nottingham NG5 1PB, UK. weishen.lim@nuh.nhs.uk

FULL TEXT

http://thorax.bmj.com/content/64/Suppl_3/iii1.long

PDF

http://thorax.bmj.com/content/64/Suppl_3/iii1.full.pdf+html

April 5, 2015 at 9:52 pm

Practice guidelines for the management of infectious diarrhea.

Clinical infectious diseases FEB.1, 2001 V.32 N.3 P.331-51

Guerrant RL, Van Gilder T, Steiner TS, Thielman NM, Slutsker L, Tauxe RV, Hennessy T, Griffin PM, DuPont H, Sack RB, Tarr P, Neill M, Nachamkin I, Reller LB, Osterholm MT, Bennish ML, Pickering LK, Infectious Diseases Society of America

1Division of Geographic and International Medicine, University of Virginia Health Sciences Center, Charlottesville, VA, USA. rlg9a@virginia.edu

The widening array of recognized enteric pathogens and the increasing demand for cost-containment sharpen the need for careful clinical and public health guidelines based on the best evidence currently available. Adequate fluid and electrolyte replacement and maintenance are key to managing diarrheal illnesses. Thorough clinical and epidemiological evaluation must define the severity and type of illness (e.g., febrile, hemorrhagic, nosocomial, persistent, or inflammatory), exposures (e.g., travel, ingestion of raw or undercooked meat, seafood, or milk products, contacts who are ill, day care or institutional exposure, recent antibiotic use), and whether the patient is immunocompromised, in order to direct the performance of selective diagnostic cultures, toxin testing, parasite studies, and the administration of antimicrobial therapy (the latter as for traveler’s diarrhea, shigellosis, and possibly Campylobacter jejuni enteritis). Increasing numbers of isolates resistant to antimicrobial agents and the risk of worsened illness (such as hemolytic uremic syndrome with Shiga toxin-producing Escherichia coli O157:H7) further complicate antimicrobial and antimotility drug use. Thus, prevention by avoidance of undercooked meat or seafood, avoidance of unpasteurized milk or soft cheese, and selected use of available typhoid vaccines for travelers to areas where typhoid is endemic are key to the control of infectious diarrhea….

PDF

http://cid.oxfordjournals.org/content/32/3/331.full.pdf+html

April 2, 2015 at 5:02 pm

Updated Recommendations for the Use of Typhoid Vaccine — Advisory Committee on Immunization Practices, United States, 2015

MMWR Weekly March 27, 2015 V.64  N.11 P.305-308

Brendan R. Jackson, MD, Shahed Iqbal, PhD, Barbara Mahon, MD.

1Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, CDC; 2Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC (Corresponding author: Brendan R. Jackson, iyn0@cdc.gov, 404-639-0536)

These revised recommendations of the Advisory Committee on Immunization Practices update recommendations published in MMWR in 1994 (1) and include updated information on the two currently available vaccines and on vaccine safety.

They also include an update on the epidemiology of enteric fever in the United States, focusing on increasing drug resistance in Salmonella enterica serotype Typhi, the cause of typhoid fever, as well as the emergence of Salmonella serotype Paratyphi A, a cause of paratyphoid fever, against which typhoid vaccines offer little or no protection…..

FULL TEXT

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6411a4.htm?s_cid=mm6411a4_e

PDF See P.305-308

http://www.cdc.gov/mmwr/pdf/wk/mm6411.pdf

 

March 29, 2015 at 10:36 am

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