Posts filed under ‘HIV/SIDA Co-infeccion HBV’

2016 BHIVA GUIDELINES for the treatment of HIV-1-positive Adults with antiretroviral therapy

The British HIV Association

Writing Group

Laura Waters (Chair)

N Ahmed, B Angus, M Boffito, M Bower, D Churchill, D Dunn, S Edwards, C Emerson, S Fidler, †M Fisher, R Horne, S Khoo, C Leen, N Mackie, N Marshall, F Monteiro, M Nelson, C Orkin, A Palfreeman, S Pett, A Phillips, F Post, A Pozniak, I Reeves, C Sabin, R Trevelion, J Walsh, E Wilkins, I Williams, A Winston

†Professor Martin Fisher died in April 2015 – he made a significant contribution to these, many other guidelines and our speciality as a whole – he is greatly missed.

Introduction

The overall purpose of these guidelines is to provide guidance on best clinical practice in the treatment and management of adults with HIV infection on antiretroviral therapy (ART).

The scope includes: (i) guidance on the initiation of ART in those previously naïve to therapy; (ii) support of people living with HIV (PLWH) on treatment; (iii) management of individuals experiencing virological failure; and (iv) recommendations in specific populations where other factors need to be taken into consideration.

The guidelines are aimed at clinical professionals directly involved with and responsible for the care of adults with HIV infection, and at community advocates responsible for promoting the best interests and care of HIV-positive adults. They should be read in conjunction with other published BHIVA guidelines.

The 2016 interim update to the 2015 BHIVA antiretroviral guidelines has been published online to include tenofovir-alafenamide/emtricitabine as a preferred NRTI backbone for first-line therapy. Changes were based on new data and the consensus opinion of the writing committee. All changes to the guideline are highlighted and include updates to the chronic kidney disease and bone disease sections of special populations and some small changes to managing virological failure. The next formal update to the guidelines in anticipated in 2017.

PDF

http://www.bhiva.org/documents/Guidelines/Treatment/2016/treatment-guidelines-2016-interim-update.pdf

December 3, 2016 at 9:33 am

2016-07-14 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

Key Updates

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

The approval of 3 fixed-dose combination products containing tenofovir alafenamide (an oral prodrug of tenofovir) and emtricitabine (TAF/FTC) prompted several changes in the What to Start section. The key changes are highlighted below:

– TAF/FTC was added as a 2-NRTI option in several Recommended and Alternative regimens, as noted in Table 6 of the guidelines. The addition of TAF/FTC to these recommendations is based on data from comparative trials demonstrating that TAF-containing regimens are as effective in achieving or maintaining virologic suppression as tenofovir disoproxil fumarate (TDF)-containing regimens and with more favorable effects on markers of bone and renal health.

– In the What to Start section, the evidence quality rating “II” was expanded to include “relative bioavailability/bioequivalence studies or regimen comparisons from randomized switch studies.” This evidence rating was broadened because not all recommended regimens were evaluated in randomized, controlled trials in antiretroviral therapy (ART)-naive patients. The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) based their recommendations for some regimens on either data from bioequivalence or relative bioavailability studies, or by extrapolating results from randomized “switch” studies that evaluated a drug’s or regimen’s ability to maintain virologic suppression in patients whose HIV was suppressed on a previous regimen. Guidance for clinicians on choosing between abacavir (ABC)-, TAF-, and TDF-containing regimens was added to What to Start.

– The lopinavir/ritonavir (LPV/r) plus 2-NRTI regimen was removed from the list of Other regimens because regimens containing this protease inhibitor (PI) combination have a larger pill burden and greater toxicity than other currently available options.

Regimen Switching

– Based on the most current data, this section was simplified to focus on switch strategies for virologically suppressed patients. The strategies are categorized as Strategies with Good Supporting Evidence, Strategies Under Evaluation, and Strategies Not Recommended.

HIV-Infected Women

– The Panel emphasizes that ART is recommended for all HIV-infected patients, including all HIV-infected women.

– The Panel also stresses the importance of early treatment for HIV-infected women during pregnancy and continuation of ART after pregnancy.

– This section was updated to include new data on interactions between antiretroviral (ARV) drugs and hormonal contraceptives.

Hepatitis B Virus (HBV)/HIV Coinfection

– This section was updated to include TAF/FTC as a treatment option for patients with HBV/HIV coinfection. Data on the virologic efficacy of TAF for the treatment of HBV in persons without HIV infection and TAF/FTC in persons with HBV/HIV coinfection are discussed.

– The Panel no longer recommends adefovir or telbivudine as options for HBV/HIV coinfected patients, as there is limited safety and efficacy data on their use in this population. In addition, these agents have a higher incidence of toxicities than other recommended treatments.

Hepatitis C Virus (HCV)/HIV Coinfection

– The text and Table 12 in this section were updated with information regarding the potential pharmacokinetic (PK) interactions between different ARV drugs and the recently approved hepatitis C drugs daclatasvir and the fixed-dose combination product of elbasvir and grazoprevir.

– Peginterferon alfa and ribavirin were removed from Table 12, as these agents do not have significant PK interactions with ARV drugs.

Tuberculosis (TB)/HIV Coinfection

– This section was updated to include a discussion on the treatment of latent tuberculosis infection (LTBI) in HIV-infected persons. The added discussion notes that a 12-week course of once-weekly rifapentine and isoniazid is an option for patients receiving either an efavirenz (EFV)- or a raltegravir (RAL)-based regimen.

– This section addresses the data from the TEMPRANO and START studies demonstrating a potential role of ART in reducing TB disease.

The recommendations and discussion regarding when to initiate ART in patients with active TB were simplified.

– As rifamycins are potent inducers of P-glycoprotein (P-gp), and TAF is a P-gp substrate, coadministration of TAF and rifamycins is not recommended.

Additional Updates

Minor revisions were made to the following sections:

– Laboratory Testing for Initial Assessment and Monitoring of HIV-Infected Patients on Antiretroviral Therapy

– Drug Resistance Testing

– Adverse Effects of Antiretroviral Agents and Tables 14 and 15

– Monthly Average Wholesale Price of Commonly Used Antiretroviral Drugs (Table 16)

– Drug Interaction Tables 18, 19a-e, and 20b

– Drug Characteristics Tables (Appendix B, Tables 1–7)

PDF

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

 

July 25, 2016 at 2:17 pm

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2016 Recommendations of the International Antiviral Society–USA Panel

JAMA July 12, 2016 V.316 N.2 P.191-210

Special Communication

Huldrych F. Günthard, MD; Michael S. Saag, MD; Constance A. Benson, MD; Carlos del Rio, MD; Joseph J. Eron, MD; Joel E. Gallant, MD, MPH; Jennifer F. Hoy, MBBS, FRACP; Michael J. Mugavero, MD, MHSc; Paul E. Sax, MD; Melanie A. Thompson, MD; Rajesh T. Gandhi, MD; Raphael J. Landovitz, MD; Davey M. Smith, MD; Donna M. Jacobsen, BS; Paul A. Volberding, MD

1University Hospital Zurich and Institute of Medical Virology, University of Zurich, Zurich, Switzerland

2University of Alabama at Birmingham, Birmingham

3University of California San Diego School of Medicine, San Diego

4Emory University Rollins School of Public Health and School of Medicine, Atlanta, Georgia

5University of North Carolina at Chapel Hill School of Medicine, Chapel Hill

6Southwest CARE Center, Santa Fe, New Mexico

7Alfred Hospital and Monash University, Melbourne, Australia

8Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

9AIDS Research Consortium of Atlanta, Atlanta, Georgia

10Massachusetts General Hospital and Harvard Medical School, Boston

11University of California Los Angeles

12University of California San Diego, La Jolla

13International Antiviral Society–USA, San Francisco, California

14University of California San Francisco

Importance 

New data and therapeutic options warrant updated recommendations for the use of antiretroviral drugs (ARVs) to treat or to prevent HIV infection in adults.

Objective 

To provide updated recommendations for the use of antiretroviral therapy in adults (aged ≥18 years) with established HIV infection, including when to start treatment, initial regimens, and changing regimens, along with recommendations for using ARVs for preventing HIV among those at risk, including preexposure and postexposure prophylaxis.

Evidence

Review  A panel of experts in HIV research and patient care convened by the International Antiviral Society–USA reviewed data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences since the 2014 report, for new data or evidence that would change previous recommendations or their ratings. Comprehensive literature searches were conducted in the PubMed and EMBASE databases through April 2016. Recommendations were by consensus, and each recommendation was rated by strength and quality of the evidence.

Findings 

Newer data support the widely accepted recommendation that antiretroviral therapy should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. Recommended optimal initial regimens for most patients are 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with 2 NRTIs. Recommendations for special populations and in the settings of opportunistic infections and concomitant conditions are provided. Reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities. Laboratory assessments are recommended before treatment, and monitoring during treatment is recommended to assess response, adverse effects, and adherence. Approaches are recommended to improve linkage to and retention in care are provided. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. When indicated, postexposure prophylaxis should be started as soon as possible after exposure.

Conclusions and Relevance 

Antiretroviral agents remain the cornerstone of HIV treatment and prevention. All HIV-infected individuals with detectable plasma virus should receive treatment with recommended initial regimens consisting of an InSTI plus 2 NRTIs. Preexposure prophylaxis should be considered as part of an HIV prevention strategy for at-risk individuals. When used effectively, currently available ARVs can sustain HIV suppression and can prevent new HIV infection. With these treatment regimens, survival rates among HIV-infected adults who are retained in care can approach those of uninfected adults.

FULL TEXT

http://jama.jamanetwork.com/article.aspx?articleid=2533073

July 17, 2016 at 4:30 pm

GeSIDA/National AIDS Plan: Consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (Updated January 2014).

Enferm Infecc Microbiol Clin. 2014 Aug-Sep;32(7):446.e1-42.

Article in Spanish

Panel de expertos de GeSIDA; Plan Nacional sobre el Sida.

Abstract

OBJECTIVE:

This consensus document is an update of combined antiretroviral therapy (cART) guidelines for HIV-1 infected adult patients.

METHODS:

To formulate these recommendations a panel composed of members of the Grupo de Estudio de Sida and the Plan Nacional sobre el Sida reviewed the efficacy and safety advances in clinical trials, cohort and pharmacokinetic studies published in medical journals (PubMed and Embase) or presented in medical scientific meetings. Recommendations strength and the evidence in which they are supported are based on modified criteria of the Infectious Diseases Society of America.

RESULTS:

In this update, antiretroviral therapy (ART) is recommended for all patients infected by type 1 human immunodeficiency virus (HIV-1). The strength and grade of the recommendation varies with the clinical circumstances: CDC stage B or C disease (A-I), asymptomatic patients (depending on the CD4+ T-lymphocyte count: <350cells/μL, A-I; 350-500 cells/μL, A-II, and >500 cells/μL, B-III), comorbid conditions (HIV nephropathy, chronic hepatitis caused by HBV or HCV, age >55years, high cardiovascular risk, neurocognitive disorders, and cancer, A-II), and prevention of transmission of HIV (mother-to-child or heterosexual, A-I; men who have sex with men, A-III). The objective of ART is to achieve an undetectable plasma viral load. Initial ART should always comprise a combination of 3 drugs, including 2 nucleoside reverse transcriptase inhibitors and a third drug from a different family (non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or integrase inhibitor). Some of the possible initial regimens have been considered alternatives. This update presents the causes and criteria for switching ART in patients with undetectable plasma viral load and in cases of virological failure where rescue ART should comprise 2 or 3 drugs that are fully active against the virus. An update is also provided for the specific criteria for ART in special situations (acute infection, HIV-2 infection, and pregnancy) and with comorbid conditions (tuberculosis or other opportunistic infections, kidney disease, liver disease, and cancer).

CONCLUSIONS:

These new guidelines updates previous recommendations related to cART (when to begin and what drugs should be used), how to monitor and what to do in case of viral failure or drug adverse reactions. cART specific criteria in comorbid patients and special situations are equally updated.

PDF

http://apps.elsevier.es/watermark/ctl_servlet?_f=10&pident_articulo=90340091&pident_usuario=0&pcontactid=&pident_revista=28&ty=107&accion=L&origen=zonadelectura&web=www.elsevier.es&lan=es&fichero=28v32n07a90340091pdf001.pdf

June 13, 2015 at 10:40 am

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

Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (Actualización enero 2014)

Enfermedades Infecciosas y Microbiología Clínica Agosto-Septiembre 2014 V.32 N.7

2014 – CONSENSO GeSIDA – TARV en adultos -Update

Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (Actualización enero 2014)

Panel de expertos de GeSIDA y Plan Nacional sobre el Sida

Objetivo

Actualizar las recomendaciones sobre el tratamiento antirretroviral (TAR) para adultos infectados por el VIH-1.

Métodos

Este documento ha sido consensuado por un panel de expertos de GESIDA y de la Secretaría del Plan Nacional sobre el Sida tras revisar los resultados de eficacia y seguridad de ensayos clínicos, estudios de cohortes y de farmacocinética publicados en revistas biomédicas (PubMed y Embase) o presentados en congresos. La fuerza de cada recomendación y la gradación de su evidencia se basan en una modificación de los criterios de la Infectious Diseases Society of America.

Resultados

Se recomienda el TAR en todos los pacientes infectados por el VIH-1. La fuerza y la gradación de la recomendación varían según la circunstancia clínica: enfermedades B o C de los CDC (A-I), pacientes asintomáticos según número de CD4+ (< 350, A-I; 350-500, A-II; > 500, B-III), comorbilidades (nefropatía por VIH, hepatitis crónica por VHB o VHC, edad superior a 55 años, riesgo cardiovascular elevado, trastornos neurocognitivos o neoplasias, A-II) y prevención de la transmisión del VIH (materno-fetal o heterosexual, A-I; homosexual entre hombres, A-III). El objetivo del TAR es lograr una carga viral plasmática (CVP) indetectable. El TAR de inicio debe ser siempre una combinación de 3 fármacos que incluya una asociación de 2 ITIAN y otro fármaco de distinta familia (ITINN, IP/r o InInt). De las posibles pautas de inicio se han considerado algunas como alternativa. Se exponen las causas y los criterios para cambiar un TAR estando con CVP indetectable, así como en el fracaso virológico en el que en el TAR de rescate se deben usar 3 o 2 fármacos plenamente activos frente al virus. Se actualizan igualmente los criterios específicos del TAR en situaciones especiales (infección aguda, infección por VIH-2, embarazo) o comorbilidades (tuberculosis u otra enfermedad oportunista, afectación renal, hepatopatías y neoplasias).

Conclusiones

Este nuevo documento actualiza las recomendaciones previas respecto a cuándo y con qué regímenes iniciar el TAR, cómo monitorizarlo y qué hacer cuando fracasa o desarrolla toxicidad. Se actualizan los criterios específicos del TAR en pacientes con comorbilidades y en situaciones especiales.

PDF

http://apps.elsevier.es/watermark/ctl_servlet?_f=10&pident_articulo=90340091&pident_usuario=0&pcontactid=&pident_revista=28&ty=107&accion=L&origen=zonadelectura&web=zl.elsevier.es&lan=es&fichero=28v32n07a90340091pdf001.pdf

 

August 30, 2014 at 8:35 pm

Guidelines for the Use of ARV Agents in HIV-1-Infected Adults and Adolescents DHHS MAY, 2014

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

PDF

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

August 30, 2014 at 8:32 pm

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