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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

Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1

N Engl J Med, July 21, 2015

Naggie and Others

BACKGROUND

Effective treatment for hepatitis C virus (HCV) in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains an unmet medical need.

METHODS

We conducted a multicenter, single-group, open-label study involving patients coinfected with HIV-1 and genotype 1 or 4 HCV receiving an antiretroviral regimen of tenofovir and emtricitabine with efavirenz, rilpivirine, or raltegravir. All patients received ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor, as a single fixed-dose combination for 12 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.

RESULTS

Of the 335 patients enrolled, 34% were black, 55% had been previously treated for HCV, and 20% had cirrhosis. Overall, 322 patients (96%) had a sustained virologic response at 12 weeks after the end of therapy (95% confidence interval [CI], 93 to 98), including rates of 96% (95% CI, 93 to 98) in patients with HCV genotype 1a, 96% (95% CI, 89 to 99) in those with HCV genotype 1b, and 100% (95% CI, 63 to 100) in those with HCV genotype 4. Rates of sustained virologic response were similar regardless of previous treatment or the presence of cirrhosis. Of the 13 patients who did not have a sustained virologic response, 10 had a relapse after the end of treatment. No patient had confirmed HIV-1 virologic rebound. The most common adverse events were headache (25%), fatigue (21%), and diarrhea (11%). No patient discontinued treatment because of adverse events.

CONCLUSIONS

Ledipasvir and sofosbuvir for 12 weeks provided high rates of sustained virologic response in patients coinfected with HIV-1 and HCV genotype 1 or 4. (Funded by Gilead Sciences; ION-4 ClinicalTrials.gov number, NCT02073656.)

PDF

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1501315

August 12, 2015 at 12:04 pm

Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1

N Engl J Med, July 21, 2015

D.L. Wyles and Others

BACKGROUND

The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1).

METHODS

This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were coinfected with HIV-1. Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses. The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks.

RESULTS

Patients had HCV genotypes 1 through 4 (83% with genotype 1), and 14% had compensated cirrhosis; 98% were receiving antiretroviral therapy. Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients. Rates of sustained virologic response across all genotypes were 97.0% (95% CI, 91.6 to 99.4), 76.0% (95% CI, 61.8 to 86.9), and 98.1% (95% CI, 89.7 to 100), respectively. The most common adverse events were fatigue, nausea, and headache. There were no study-drug discontinuations because of adverse events. HIV-1 suppression was not compromised.

CONCLUSIONS

Among previously untreated HIV–HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection, the rate of sustained virologic response across all genotypes was 97.0% after 12 weeks of treatment and 76.0% after 8 weeks. (Funded by Bristol-Myers Squibb; ALLY-2 ClinicalTrials.gov number, NCT02032888.)

PDF

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1503153

 

August 12, 2015 at 12:03 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

CONSENSO GeSIDA TARV en adultos

2015-01 CONSENSO GeSIDA TARV en adultos EIMC 101 págs.

PDF

http://www.seimc.org/contenidos/gruposdeestudio/gesida/dcientificos/documentos/2015/gesida-guiasclinicas-2015-tar.pdf

 

March 6, 2015 at 8:56 am

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