HIV Drug resistanceimplications

Size: px
Start display at page:

Download "HIV Drug resistanceimplications"

Transcription

1 HIV Drug resistanceimplications for therapy Deenan Pillay Africa Centre for Health and Population Studies, UKZN University College London

2 Potential implications of HAART without virological monitoring: Therapy failure? CD4 count VL Months Years VL 1 Treatment onset Virological failure (>1c/mL) Clinical failure (AIDS events) increasing resistance

3 All viruses are archived and can re-emerge Drug pressure Resistance testing only detects the majority virus population in plasma wild type drug-resistant virus

4 IMPACT OF VIRAL VARIATION/QUASISPECIES Potency Durability Viral load total majority susceptible strain minority resistant strain time -FIRST PHASE VIRAL DECLINE AS AN IN VIVO PHENOTYPE

5 HOW TO DEFINE RESISTANCE? Genotype- mutations, collections of mutations In vitro phenotype fold resistance, gene of choice Clinical response- complexity of multiple drugs

6 Phenotyping Inhibition of viral replication (%) 1 Susceptible strain Wild type Resistant strain 5 Resistance IC 5 IC 5 IC 5 Drug concentration

7 ZDV/3TC/ABC: Example of Slow Stepwise Appearance of Mutations in Subjects With Virologic Failure Plasma HIV-1 RNA Log WT 5 c/ml 4 c/ml 5 c/ml M184V D67N/D, K7R/K, M184V M184V, T215T/Y M41L/M, M184V, T215Y M41L, M184V, T215Y M41L, M184V, L21L/W, T215Y 28 weeks of M184V only ABC=5.9, ZDV=4.1fold Study week ABC=6.2, ZDV=12.2 fold

8 The intensity of virological monitoring is associated with resistance to 1 st line HAART 7% 6% 5.9% 6.1% 5% 4% 3% 2.7% 2% 1.7% 2.1% 1% %.7%.1%.3% Any TAMS M184V/I 3rd Agent K65R Any TAMS M184V/I 3rd Agent K65R Frequent viral load monitoring Infrequent/no viral load monitoring Gupta et al CID 29

9 INCIDENCE OF RESISTANCE IN VIROLOGICAL FAILURES ON 1ST LINE NNRTI- OR bpi- CONTAINING REGIMENS: A META ANALYSIS 6% 53.% 5% 4% 35.3% 3% 21.% 2% 1% 5.3% %.3% Major NNRTI.6%.9%.% M184V/I Any TAMS Major PI K65R Major NNRTI 1.5%.% M184V/I Any TAMS Major PI K65R PI Studies NNRTI Studies Gupta et al, LID 29

10 Antiviral dynamics determines HIV evolution and predicts therapy outcome Rosenbloom et al, Nat Med 212

11

12 Virological response

13 Emerging resistance

14 High rates of re-suppression after virological failure on first line therapy in the absence of routine monitoring: 96 week data from the DART NORA substudy Gupta et al Clin Inf Dis 214

15 Evidence on HIV drug resistance testing Dunn et a, 27

16 Population impact of drug resistance - will spread of HIV drug resistance require change of 1 st line therapy?

17 TDR and time since roll out East Africa: Estimated proportion with NNRTI TDR 8 years after start of roll out = 7.4% Gupta et al, Lancet, 212 Also: Frenz et al; AIDS rev 212

18

19 POPART intervention; modelling outcome Christophe Fraser

20 Will ART expansion in SA lead to a relative increase in HIV drug resistance? Cambiano, Bertagnolio, Jordon, Pillay, Perriens,Ventner, Lungren, Phillips. AIDS, 214

21 Meta-analysis demonstrates importance of M184V minority assays Continuity Ratio of new Study Year Standard AS-PCR N correction detections (95% CI) K13N Metzner (1., 1.94) Metzner (1., ) Metzner (1., 91.11) Johnson Pillay Buckton Coovadia (1.16, 25.2) 3. (1., 28.84) 1.2 (1., 1.55) 3. (1.19, 7.56) K13N Hauser (1., 59.66) Metzner (1., ) Metzner (1., 28.84) Paredes (1.4, 4.2) Toni (1., 91.11) D+L Subtotal (I-squared = 54.4%, p=.12) 2.21 (1.49, 3.29) I-V Subtotal 1.44 (1.22, 1.7). M184V Metzner (1., 35.91) Metzner (1.53, ) Metzner Johnson Buckton Metzner (1., ) 3. (1., 28.84) 13. (1.98, 85.46) 23. (1.53, ) M184V Metzner (1., ) Toni (1., ) Vignoles (2.3, ) D+L Subtotal (I-squared =.%, p=.878) 9.32 (4.46, 19.44) I-V Subtotal 9.32 (4.46, 19.44). NOTE: Weights are from random effects analysis

22 Objective To assess the impact of transmitted drug resistance mutations on virological and immunological response up to 16 months after starting a combination antiretroviral therapy (cart) Specific analyses: Transmitted drug resistance and fully active treatment 2NRTI + 1NNRTI or 2NRTI + 1boosted PI regimen Study population HIV infected patients regardless of age Start of cart after sample taken before antiretroviral treatment for genotypic testing 22

23 Methods Virologic endpoint: time to first of two consecutive viral load>5 copies/ml after six months of therapy Definition TDR (two steps): WHO list 29 1 Patients having at least one mutation Stanford 2 version 6..5 Group Patients with no detected mutation (used as a reference group) Group 1 show no drug resistance to their prescribed drug (classified as susceptible or as potential low level resistance ) Group 2 resistant to at least one of their prescribed drugs (classified as Low-level resistance, Intermediate' or as High level resistance ) 1 Bennett PlosOne 29, 2 Liu CID 26 23

24 Characteristics at the time of starting cart 1,56 patients from 25 cohorts 76% male Median age 38 years 56% of European origin 69% harboured a subtype B virus Pre-treatment viral load and CD4 counts were 5 log1 cp/ml and 218 cells/μl Transmission risk groups: 5% homosexual, 32% heterosexual, 8% IDUs and 2.1% perinatal 9.5% (n=954) patients harboured a virus with 1 mutation 49.8% (n=475) received a fully active treatment 5.2% (n=479) harboured a virus predicted to have at 24 least low level resistance for 1 prescribed drug

25 Virological failure according to TDR In adjusted analysis*: Patients with resistance to 1 drug: - significant higher risk of VF compared to patients without mutations - HR: 3.3 (2.5; 4.4) P<1-4 % VF patients receiving a fully active cart and patients with no mutation: - risk of VF was not significantly different - HR: 1.4 (.9; 2.3) P= Time after start of therapy (month) *All models stratified by cohort ; multivariable models ajusted for: Gender, age, pre-treatment viral load and CD4 count, year of treatment start, previous AIDS diagnosis, subtype, HIV transmission risk group, origin 25

26 Impact of TDR according to treatment strata HR* No TDR TDR TDR No TDR TDR TDR No TDR No TDR TDR and TDR and No TDR TDR and TDR and No TDR and and and and fullyactive fully resistant fullyactive resistant resistant fully resistant active active cart cart TDR TDR and and fullyactive fully active cart ALL 2NRTIs + 1NNRTI 2NRTIs + PI/rtv ALL 2NRTI+1NNRTI 2NRTI+1PI/rtv TDR TDR and and resistant resistant *All models stratified by cohort ; multivariable models ajusted for: Gender, age, pre-treatment viral load and CD4 count, year of treatment start, previous AIDS diagnosis, subtype, HIV transmission risk group, origin 26

27 From: Efficacy and Tolerability of 3 Nonnucleoside Reverse Transcriptase Inhibitor Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1: A Randomized, Controlled Equivalence TrialNNRTI-Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1 Ann Intern Med. 214;161(7): doi:1.7326/m Figure Legend: Outcomes at week 96, according to the FDA snapshot definition. ART = antiretroviral therapy; ATV/r = atazanavir plus ritonavir; DRV/r = darunavir plus ritonavir; FDA = U.S. Food and Drug Administration; RAL = raltegravir. Date of download: 1/9/214 Copyright American College of Physicians. All rights reserved.

28 Conclusion Differential resistance on 1 st line therapy Impact of resistance is a function of therapeutic availability increase transmission of resistance likely with extended roll out

Theonest Ndyetabura KILIMANJARO CHRISTIAN MEDICAL CENTRE / KILIMANJARO CLINICAL RESERCH

Theonest Ndyetabura KILIMANJARO CHRISTIAN MEDICAL CENTRE / KILIMANJARO CLINICAL RESERCH TREATMENT FAILURE AND PATTERNS OF GENOTYPIC DRUG RESISTANCE MUTATIONS AMONG HAART EXPERIENCED HIV-1 PATIENTS AT KCMC Theonest Ndyetabura KILIMANJARO CHRISTIAN MEDICAL CENTRE / KILIMANJARO CLINICAL RESERCH

More information

HIV Drug Resistance in the Asia- Pacific

HIV Drug Resistance in the Asia- Pacific HIV Drug Resistance in the Asia- Pacific David A Cooper National Centre in HIV Epidemiology and Clinical Research The University of New South Wales Sydney, Australia HIVDR in Asia Pacific Transmitted resistance

More information

Poster # 42 Resistance in PBMCs Can Predict Virological Rebound after Therapy Switch in cart- Treated Patients with Undetectable HIV-RNA

Poster # 42 Resistance in PBMCs Can Predict Virological Rebound after Therapy Switch in cart- Treated Patients with Undetectable HIV-RNA Poster # 42 Resistance in PBMCs Can Predict Virological Rebound after Therapy Switch in cart- Treated Patients with Undetectable HIV-RNA D Armenia 1, M Zaccarelli 2, V Borghi 3, W Gennari 3, A Giannetti

More information

Switch to Dolutegravir plus Rilpivirine dual therapy in cart-experienced Subjects: an Italian cohort

Switch to Dolutegravir plus Rilpivirine dual therapy in cart-experienced Subjects: an Italian cohort Switch to Dolutegravir plus Rilpivirine dual therapy in cart-experienced Subjects: an Italian cohort Gaetana Sterrantino Azienda Ospedaliero-Universitaria Careggi Infectious diseases, Florence, Italy Background

More information

Paediatric HIV Drug Resistance in African Settings

Paediatric HIV Drug Resistance in African Settings Paediatric HIV Drug Resistance in African Settings Dr Cissy Kityo Mutuluuza INTEREST Meeting May 5-9, 2014 Lusaka, Zambia Background: ART for children in sub- Saharan Africa 2.3 million children with HIV

More information

Clinical rationale for viral load testing

Clinical rationale for viral load testing Clinical rationale for viral load testing Francois Venter Wits Reproductive Health & HIV Institute Caveats I m a believer in VLs My talk looks at resource poor environments Why do we need a rationale???

More information

Protease Inhibitor Resistance at 2nd-line HIV Treatment Failure in Sub-Saharan Africa

Protease Inhibitor Resistance at 2nd-line HIV Treatment Failure in Sub-Saharan Africa Protease Inhibitor Resistance at 2nd-line HIV Treatment Failure in Sub-Saharan Africa T. Sonia Boender; Raph L. Hamers; Pascale Ondoa; Maureen Wellington; Cleophas Chimbetete; Margaret Siwale; Eman E F

More information

Combination Anti-Retroviral Therapy (CART) - Rationale and Recommendation. M Dinaker. Fig.1: Effect of CART on CD4 and viral load

Combination Anti-Retroviral Therapy (CART) - Rationale and Recommendation. M Dinaker. Fig.1: Effect of CART on CD4 and viral load Combination Anti-Retroviral Therapy (CART) - Rationale and Recommendation M Dinaker INTRODUCTION The wide availability of effective, safe and mostly well tolerated combined anti-retroviral therapy (CART)

More information

London Therapeutic Tender Implementation: Guidance for Clinical Use. 4 th June 2014 FINAL

London Therapeutic Tender Implementation: Guidance for Clinical Use. 4 th June 2014 FINAL London Therapeutic Tender Implementation: Guidance for Clinical Use 4 th June 2014 FINAL Contents 3. General principles 4. Financial impact of therapeutic tendering for branded ARVs 5. London ARV algorithm:

More information

MM Thorell PhD University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, Pennsylvania, , USA.

MM Thorell PhD University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, Pennsylvania, , USA. Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 148 SUMMARY OF GUIDELINES FOR THE USE OF ANTIRETROVIRAL AGENTS IN HIV-INFECTED ADULTS AND ADOLESCENTS. MM Thorell PhD University of the Sciences

More information

EACS 2013. Dominique Braun Universitätsspital Zürich

EACS 2013. Dominique Braun Universitätsspital Zürich EACS 2013 Switch data Rilpivirine: Swing-trial Elvitegravir: Flamingo-trial Simplification Dual-Therapy: LPV/r + 3TC in the Gardel-trial Mono-Therapy: Darunavir/r mono in clinical setting Boceprevir/Telaprevir

More information

Protocol for the systematic review of virological outcomes after 12 Months of antiretroviral therapy in low and middle income countries

Protocol for the systematic review of virological outcomes after 12 Months of antiretroviral therapy in low and middle income countries Protocol for the systematic review of virological outcomes after 12 Months of antiretroviral therapy in low and middle income countries 1. Authors James H. McMahon Alfred Hospital, Melbourne, Australia

More information

Low level viremia and HIV-1 drug resistance in patients with virological rebound after suppression with a first line antiretroviral regimen

Low level viremia and HIV-1 drug resistance in patients with virological rebound after suppression with a first line antiretroviral regimen Low level viremia and HIV-1 drug resistance in patients with virological rebound after suppression with a first line antiretroviral regimen Manuela Colafigli Catholic University of S. Heart Rome, Italy

More information

Antiretroviral Therapy Guidelines

Antiretroviral Therapy Guidelines NORTHWEST AIDS EDUCATION AND TRAINING CENTER Antiretroviral Therapy Guidelines Christian B. Ramers, MD, MPH Medical Director, NW AETC ECHO Assistant Professor of Medicine & Global Health, University of

More information

Reference: NHS England B06/P/a

Reference: NHS England B06/P/a Clinical Commissioning Policy: Dolutegravir for treatment of HIV- 1 in adults and adolescents Reference: NHS England B06/P/a 1 NHS England Clinical Commissioning Policy: Dolutegravir for treatment of HIV-1

More information

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

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Visit the AIDSinfo website to access the most up-to-date guideline. Register for e-mail notification of guideline

More information

Antiretroviral Therapy

Antiretroviral Therapy Scott M. Hammer Antiretroviral Therapy I. Introduction The field of antiretroviral therapy has been explosive over the past 17 years as HIV targets have been identified, drugs developed and pathogenesis

More information

A 12-22 Month Follow-Up of HIV Patients Whose Therapy Was Optimized by Using HIV Genotyping

A 12-22 Month Follow-Up of HIV Patients Whose Therapy Was Optimized by Using HIV Genotyping A 12-22 Month Follow-Up of HIV Patients Whose Therapy Was Optimized by Using HIV Genotyping Cynthia J. Carlyn, MD * Aldona L. Baltch, MD * Marty H. St. Clair, BS Mary J. George, PhD * Raymond P. Smith,

More information

Virologic suppression outcomes of second-line antiretroviral therapy in a Nigerian cohort.

Virologic suppression outcomes of second-line antiretroviral therapy in a Nigerian cohort. TUPE089 Virologic suppression outcomes of second-line antiretroviral therapy in a Nigerian cohort. Authors: Adedotun A. Adetunji 1, MBChB, MSc; Chad Achenbach 2, MD, MPH; Joseph Feinglass 3, PhD; Kristin

More information

Perspective Incomplete Viral Suppression Under Potent Antiretroviral Therapy: Determinants of Treatment Outcome

Perspective Incomplete Viral Suppression Under Potent Antiretroviral Therapy: Determinants of Treatment Outcome Perspective Incomplete Viral Suppression Under Potent Antiretroviral Therapy: Determinants of Treatment Outcome At the International AIDS Society USA course in Los Angeles in March 22, Steven G. Deeks,

More information

Antiretroviral therapy for HIV infection in infants and children: Towards universal access

Antiretroviral therapy for HIV infection in infants and children: Towards universal access Antiretroviral therapy for HIV infection in infants and children: Towards universal access Executive summary of recommendations Preliminary version for program planning 2010 Executive summary Tremendous

More information

5.1 Types of Medications

5.1 Types of Medications 5.1 Types of Medications Nucleoside, Nucleotide & Non-Nucleoside Reverse-Transcriptase Inhibitors (NRTI, NtRTI and NNRTI) HIV is a single stranded RNA virus. In order to make more copies of itself in a

More information

The Basics of Drug Resistance:

The Basics of Drug Resistance: CONTACT: Lisa Rossi +1-412-641-8940 +1-412- 916-3315 (mobile) rossil@upmc.edu The Basics of Drug Resistance: QUESTIONS AND ANSWERS HIV Drug Resistance and ARV-Based Prevention 1. What is drug resistance?

More information

STOP HIV/AIDS Pilot Project

STOP HIV/AIDS Pilot Project STOP HIV/AIDS Pilot Project INDICATORS QUARTERLY REPORT: 1 October through 31 December SUBMITTED TO: The BC Ministry of Health Services SUBMITTED BY: Dr. Rolando Barrios, Dr. Mark Gilbert, Dr. Kate Health,

More information

in HIV/HCV-Coinfected Patients: role of the HCV sustained viral suppression

in HIV/HCV-Coinfected Patients: role of the HCV sustained viral suppression M42-Determinants M19 of HIV Sustained Viral Suppression in HIV/HCV-Coinfected Patients: role of the HCV sustained viral suppression F. Bani-Sadr 1-2, M-A Loko 2, E. Pambrun 2, M. Winnock 2, P. Carrieri

More information

Testing for HIV Drug Resistance

Testing for HIV Drug Resistance State of the Art Testing for HIV Drug Resistance Victor S.B. Jorden, MD, MPH Sindy M. Paul, MD, MPH Today, many patients with HIV infection are able to live longer and better lives, owing to the use of

More information

Clinical Commissioning Policy: Stribild for the treatment of HIV-1 infection in adults

Clinical Commissioning Policy: Stribild for the treatment of HIV-1 infection in adults Clinical Commissioning Policy: Stribild for the treatment of HIV-1 infection in adults Reference: NHS England B06/P/x 1 Clinical Commissioning Policy: Stribild for the treatment of HIV-1 infection in adults

More information

Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients. Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA

Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients. Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA Liver disease is the second leading cause of death amongst HIV-positive

More information

Chapter 36. Media Directory. Characteristics of Viruses. Primitive Structure of Viruses. Therapy for Viral Infections. Drugs for Viral Infections

Chapter 36. Media Directory. Characteristics of Viruses. Primitive Structure of Viruses. Therapy for Viral Infections. Drugs for Viral Infections Chapter 36 Media Directory Drugs for Viral Infections Slide 23 Slide 27 Slide 29 Zidovudine Animation Saquinavir Mesylate Animation Acyclovir Animation Upper Saddle River, New Jersey 07458 All rights reserved.

More information

Antiretroviral Therapy for HIV Infection: When to Initiate Therapy, Which Regimen to Use, and How to Monitor Patients on Therapy

Antiretroviral Therapy for HIV Infection: When to Initiate Therapy, Which Regimen to Use, and How to Monitor Patients on Therapy Perspective Antiretroviral Therapy for HIV Infection: When to Initiate Therapy, Which Regimen to Use, and How to Monitor Patients on Therapy Antiretroviral therapy is recommended for all patients with

More information

Antiretroviral Drug Resistance Testing in Adult HIV-1 Infection: 2008 Recommendations of an International AIDS Society USA Panel

Antiretroviral Drug Resistance Testing in Adult HIV-1 Infection: 2008 Recommendations of an International AIDS Society USA Panel HIV/AIDS REVIEW ARTICLE Antiretroviral Drug Resistance Testing in Adult HIV-1 Infection: 2008 Recommendations of an International AIDS Society USA Panel Martin S. Hirsch, 1 Huldrych F. Günthard, 9 Jonathan

More information

Surveillance of transmitted HIV drug resistance among women attending antenatal clinics in Dar es Salaam, Tanzania

Surveillance of transmitted HIV drug resistance among women attending antenatal clinics in Dar es Salaam, Tanzania Antiviral Therapy 13 Suppl 2:77 82 Surveillance of transmitted HIV drug resistance among women attending antenatal clinics in Dar es Salaam, Tanzania Geofrey R Somi 1, Tabitha Kibuka 2, Karidja Diallo

More information

Die Toronto Konferenz. K. Arasteh Auguste-Viktoria-Klinikum

Die Toronto Konferenz. K. Arasteh Auguste-Viktoria-Klinikum Die Toronto Konferenz K. Arasteh Auguste-Viktoria-Klinikum Subjektive Schwerpunkte Medizinische Prävention Monotherapie CD4 guided treatment interuption (CD4-TI) HIV Prävention (Gita Ramjee) Rationale

More information

European Recommendations for the Clinical Use of HIV Drug Resistance Testing: 2011 Update

European Recommendations for the Clinical Use of HIV Drug Resistance Testing: 2011 Update AIDS Rev. 2011;13:77-108 Anne-Mieke Vandamme, et al.: European HIV Drug Resistance Guidelines European Recommendations for the Clinical Use of HIV Drug Resistance Testing: 2011 Update Anne-Mieke Vandamme

More information

HIV Diagnosis. HIV Diagnosis and Pathogenesis. Laboratory Diagnosis of Established HIV Infection: Antibody Detection

HIV Diagnosis. HIV Diagnosis and Pathogenesis. Laboratory Diagnosis of Established HIV Infection: Antibody Detection HIV Diagnosis HIV Diagnosis and Pathogenesis Scott M. Hammer, M.D. Consider in anyone presenting with symptoms and signs compatible with an HIV-related syndrome or in an asymptomatic person with a risk

More information

HIV/Hepatitis C co-infection. Update on treatment Eoin Feeney

HIV/Hepatitis C co-infection. Update on treatment Eoin Feeney HIV/Hepatitis C co-infection Update on treatment Eoin Feeney HIV/Hepatitis C coinfection Where we are now Current treatment regimens and outcomes What s coming soon Direct acting antivirals (DAAs) What

More information

Updated HIV Treatment Guidelines 2014

Updated HIV Treatment Guidelines 2014 NORTHWEST AIDS EDUCATION AND TRAINING CENTER Updated HIV Treatment Guidelines 2014 Brian R. Wood, MD Assistant Professor of Medicine, University of Washington Medical Director, NW AETC ECHO Last Updated:

More information

Generic antiretrovirals in Europe: a blessing or a curse?

Generic antiretrovirals in Europe: a blessing or a curse? Generic antiretrovirals in Europe: a blessing or a curse? Ricardo Jorge Camacho 1 Molecular Biology Laboratory, Centro Hospitalar de Lisboa Ocidental 2 Instituto de Higiene e Medicina Tropical, Universidade

More information

British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006)

British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006) r 2006 British HIV Association HIV Medicine (2006), 7, 487 503 British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006) B Gazzard on behalf

More information

HIV Guidelines. New Strategies.

HIV Guidelines. New Strategies. HIV Guidelines. New Strategies. Santiago Moreno Hospital Universitario Ramón y Cajal Madrid HIV Guidelines. New Strategies. Outline HIV Guidelines What is new? New strategies Treatment as Prevention HIV

More information

Lessons from the Stanford HIV Drug Resistance Database

Lessons from the Stanford HIV Drug Resistance Database 1 Lessons from the Stanford HIV Drug Resistance Database Bob Shafer, MD Department of Medicine and by Courtesy Pathology (Infectious Diseases) Stanford University Outline 2 Goals and rationale for HIVDB

More information

Guidance for Industry Role of HIV Resistance Testing in Antiretroviral Drug Development

Guidance for Industry Role of HIV Resistance Testing in Antiretroviral Drug Development Guidance for Industry Role of HIV Resistance Testing in Antiretroviral Drug Development U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

More information

The Impact of Boosted Darunavir Monotherapy on Neurocognitive Function and Quality of Life: Results from a Prospective Randomised Study

The Impact of Boosted Darunavir Monotherapy on Neurocognitive Function and Quality of Life: Results from a Prospective Randomised Study 21 st Annual Conference of the British HIV Association (BHIVA) 21-24 April 2015, Brighton, UK The Impact of Boosted Darunavir Monotherapy on Neurocognitive Function and Quality of Life: Results from a

More information

HIV Reports. Antiretroviral Stewardship in a Pediatric HIV Clinic. Development, Implementation and Improved Clinical Outcomes

HIV Reports. Antiretroviral Stewardship in a Pediatric HIV Clinic. Development, Implementation and Improved Clinical Outcomes HIV Reports Antiretroviral Stewardship in a Pediatric HIV Clinic Development, Implementation and Improved Clinical Outcomes Alice J. Hsu, PharmD, BCPS, AQ-ID,* Asha Neptune, MA, MPH, Constants Adams, BS,

More information

Cascade of Care and its relevance to Seek, Test, Treat and Retain Strategy. Carlos del Rio, MD Emory Center for AIDS Research

Cascade of Care and its relevance to Seek, Test, Treat and Retain Strategy. Carlos del Rio, MD Emory Center for AIDS Research Cascade of Care and its relevance to Seek, Test, Treat and Retain Strategy Carlos del Rio, MD Emory Center for AIDS Research In order for a person to benefit from HIV treatment success it is necessary

More information

Paediatric HIV treatment update

Paediatric HIV treatment update Paediatric HIV treatment update James Nuttall Red Cross War Memorial Children s Hospital & University of Cape Town ART Resistance & New Treatment Options 6 th FIDSSA Conference, 5-7 November 2015 ART Eligibility

More information

Management of HIV/HCV Co-infected Patients

Management of HIV/HCV Co-infected Patients Management of HIV/HCV Co-infected Patients David Wyles, MD Associate Professor of Medicine Division of Infectious Diseases University of California, San Diego San Diego, California Disclosures Grants/Research

More information

Chapter 3 South African guidelines and introduction to clinical cases

Chapter 3 South African guidelines and introduction to clinical cases Chapter 3 South African guidelines and introduction to clinical cases 3.1. South African national antiretroviral guidelines When this book was published in 2012 the current national antiretroviral treatment

More information

Antiretroviral Drugs in the Treatment and Prevention of HIV Infection

Antiretroviral Drugs in the Treatment and Prevention of HIV Infection Antiretroviral Drugs in the Treatment and Prevention of HIV Infection Noga Shalev, MD Uses of Antiretroviral Agents Treatment of chronic HIV infection Prevention of mother-to-child transmission [PMTCT]

More information

Aids Fonds funding for programmes to prevent HIV drug resistance

Aids Fonds funding for programmes to prevent HIV drug resistance funding for programmes to prevent HIV drug resistance Call for proposals July 2012 Page 1 van 10 grants@aidsfonds.nl Documentnumber 20120719/JKA/RAP Universal Access Lifting barriers to universal access

More information

Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment Guidance for Industry

Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment Guidance for Industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

HIV Diagnosis and Treatment Updates ACP DC Chapter. Frank Maldarelli HIV Dynamics and Replication Program, NCI, NIH November 5, 2016

HIV Diagnosis and Treatment Updates ACP DC Chapter. Frank Maldarelli HIV Dynamics and Replication Program, NCI, NIH November 5, 2016 HIV Diagnosis and Treatment Updates ACP DC Chapter Frank Maldarelli HIV Dynamics and Replication Program, NCI, NIH November 5, 2016 NONE Disclosures Objectives HIV Testing Updates HIV Treatment Update

More information

Predictors for antiretroviral therapy (ART) failure in an urban HIV/AIDS clinic in Addis Ababa, Ethiopia

Predictors for antiretroviral therapy (ART) failure in an urban HIV/AIDS clinic in Addis Ababa, Ethiopia Predictors for antiretroviral therapy (ART) failure in an urban HIV/AIDS clinic in Addis Ababa, Ethiopia Katherine Niemeyer, Akilah King, Sophie Mengistu, Nils Hennig Department of Medical Education, Department

More information

HIV Genotyping and Phenotyping

HIV Genotyping and Phenotyping Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

What is bias and how can it affect the outcomes from research?

What is bias and how can it affect the outcomes from research? What is bias and how can it affect the outcomes from research? Caroline A. Sabin Dept. Infection and Population Health UCL, Royal Free Campus London, UK Bias Bias occurs when there is a systematic difference

More information

Southern African HIV Clinicians Society Clinical Guidelines Antiretroviral therapy in adults

Southern African HIV Clinicians Society Clinical Guidelines Antiretroviral therapy in adults Southern African HIV Clinicians Society Clinical Guidelines Antiretroviral therapy in adults Introduction The magnitude of HIV infection in Southern African and the number of impoverished people who desperately

More information

Guidance for Industry Antiviral Product Development Conducting and Submitting Virology Studies to the Agency

Guidance for Industry Antiviral Product Development Conducting and Submitting Virology Studies to the Agency Guidance for Industry Antiviral Product Development Conducting and Submitting Virology Studies to the Agency U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

APPENDIX C: Viral Load Suppression Measures

APPENDIX C: Viral Load Suppression Measures Newark EMA HIV Health Services Planning Council Needs Assessment 2012 Update APPENDIX C: Viral Load Suppression Measures Page C-1 APPENDIX C: Viral Load Suppression Measures in+care Campaign Measures November

More information

The question and answer session is not available after the live webinar.

The question and answer session is not available after the live webinar. 1 Read verbatim. 2 The Infectious Diseases Society of America (IDSA) Hepatitis C Knowledge Network offers monthly, 1 hour webinars to educate IDSA members on current recommended practices and treatments

More information

The prevalence of transmitted antiretroviral drug resistance in treatment-naïve patients and factors influencing firstline treatment regimen selection

The prevalence of transmitted antiretroviral drug resistance in treatment-naïve patients and factors influencing firstline treatment regimen selection DOI: 10.1111/j.1468-1293.2008.00561.x r 2008 Merck & Co., Inc. HIV Medicine (2008), 9, 285 293 ORIGINAL RESEARCH The prevalence of transmitted antiretroviral drug resistance in treatment-naïve patients

More information

Janssen Global Public Health: HIV Medicines Access & Partnerships Program APRIL 2014. Julius Bustamante, Pajaros

Janssen Global Public Health: HIV Medicines Access & Partnerships Program APRIL 2014. Julius Bustamante, Pajaros Julius Bustamante, Pajaros Artwork from Hospital Audiences, Inc. (HAI), a nonprofit organization that inspires healing, growth and learning through access to the arts for the culturally underserved. Janssen

More information

SURVEILLANCE OF INITIAL DRUG RESISTANT HIV-1 AMONG CHILDREN UNDER 18 MONTHS OF AGE NEWLY DIAGNOSED WITH HIV

SURVEILLANCE OF INITIAL DRUG RESISTANT HIV-1 AMONG CHILDREN UNDER 18 MONTHS OF AGE NEWLY DIAGNOSED WITH HIV SURVEILLANCE OF INITIAL DRUG RESISTANT HIV-1 AMONG CHILDREN UNDER 18 MONTHS OF AGE NEWLY DIAGNOSED WITH HIV SURVEY REPORT AIDS & TB UNIT Ministry Of Health And Child Welfare Zimbabwe December 2012 1 Table

More information

DETERMINANTS OF HIV DRUG RESISTANCE TESTING IN BRITISH COLUMBIA

DETERMINANTS OF HIV DRUG RESISTANCE TESTING IN BRITISH COLUMBIA DETERMINANTS OF HIV DRUG RESISTANCE TESTING IN BRITISH COLUMBIA by Oghenowede Eyawo MSc. (Zoology), Karl-Franzens University, 2005 BSc. (Zoology), University of Benin, 2000 PROJECT SUBMITTED IN PARTIAL

More information

Decision Analysis Example

Decision Analysis Example Options for Doing Cost-Effectiveness Analysis Decision Analysis Example after Occupational Exposure to Clinical trial Mathematical modeling Clinical Trial Incremental Cost-Effectiveness Ratio Conduct a

More information

Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES. www.msfaccess.

Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES. www.msfaccess. Treatment Action Campaign UNDETECTABLE HOW VIRAL LOAD MONITORING CAN IMPROVE HIV TREATMENT IN DEVELOPING COUNTRIES www.msfaccess.org Table of Contents 3 Executive Summary 4 Introduction 5 MSF HIV/AIDS

More information

The Effects of Cycling on Drug Resistance HIV

The Effects of Cycling on Drug Resistance HIV The Effects of Cycling on Drug Resistance HIV Aaron Abromowitz 1, Andre Robinson 2 Walter Chambliss 3, Emmanuel J. Morales-Butler 4, Anuj Mubayi 5, Xiaohong Wang 5, Abdessemad Tridane 5 1 Department of

More information

AIMS ESSAY PRESENTATION

AIMS ESSAY PRESENTATION JAMES MALM AFRICAN INSTITUTE FOR MATHEMATICAL SCIENCES AIMS ESSAY PRESENTATION 1 Long term Dynamics of HIV disease progression with a non-sterilizing vaccine 0.1 Introduction Vaccines have been used for

More information

HIV DRUG RESISTANCE EARLY WARNING INDICATORS

HIV DRUG RESISTANCE EARLY WARNING INDICATORS HIV DRUG RESISTANCE EARLY WARNING INDICATORS World Health Organization indicators to monitor HIV drug resistance prevention at antiretroviral treatment sites June 2010 Update ACKNOWLEDGEMENTS The preparation

More information

The Future in HIV treatment in South Africa. Dr Francesca Conradie President of the Southern African HIV Clinicians Society

The Future in HIV treatment in South Africa. Dr Francesca Conradie President of the Southern African HIV Clinicians Society The Future in HIV treatment in South Africa Dr Francesca Conradie President of the Southern African HIV Clinicians Society The big picture Test and Treat The patient level New compounds New Formulations

More information

Abracadabra: Magic Johnson and Anti-HIV Treatments

Abracadabra: Magic Johnson and Anti-HIV Treatments Abracadabra: Magic Johnson and Anti-HIV Treatments Part I "Background" "It's not going to happen to me. And I'm here saying that it can happen to anybody, even me, Magic Johnson." These words were spoken

More information

1 2 3 4 5 6 Figure 4.1: Gel picture showing Generation of HIV-1subtype C codon optimized env expressing recombinant plasmid pvax-1:

1 2 3 4 5 6 Figure 4.1: Gel picture showing Generation of HIV-1subtype C codon optimized env expressing recombinant plasmid pvax-1: Full-fledged work is in progress towards construction and cloning of codon optimized envelope with subsequent aims towards immunization of mice to study immune responses. 1 2 4 5 6 Figure 4.1: Gel picture

More information

Chapter 10 Human Immuno Deficiency Virus Infection

Chapter 10 Human Immuno Deficiency Virus Infection 143 Chapter 10 Human Immuno Deficiency Virus Infection Chapter 10 Human Immuno Deficiency Virus Infection...143 HIV infection...144 Clinical Features...146 Clinical Staging of HIV infection recommended

More information

HIV Treatment As HIV Prevention

HIV Treatment As HIV Prevention HIV Treatment As HIV Prevention HIV/AIDS and Substance Abuse Nora D. Volkow, M.D. Director National Institute on Drug Abuse National Institutes of Health Few could have imagined that we d be talking about

More information

HIV Testing: New Tests and Updated Recommendations

HIV Testing: New Tests and Updated Recommendations HIV Testing: New Tests and Updated Recommendations Bernard M. Branson, M.D. Associate Director for Laboratory Diagnostics CDC Division of HIV/AIDS Prevention The findings and conclusions are those of the

More information

Routine HIV Monitoring

Routine HIV Monitoring Routine HIV Monitoring Guideline of the HIV/AIDS Division at San Francisco General Hospital Statement of Guideline: Patients will be routinely evaluated and monitored for HIV parameters, antiretroviral

More information

Recent advances of 台 中 榮 總 內 科 部 胃 腸 肝 膽 科 呂 宜 達 醫 師 2013.03.28

Recent advances of 台 中 榮 總 內 科 部 胃 腸 肝 膽 科 呂 宜 達 醫 師 2013.03.28 Recent advances of HBV and HCV co-infection 台 中 榮 總 內 科 部 胃 腸 肝 膽 科 呂 宜 達 醫 師 2013.03.28 Outline Epidemiology of HBV and HCV coinfection Clinical significance of HBV and HCV coinfection Interplay between

More information

Positive impact of HCV treatment initiation on health outcomes in injecting drug users

Positive impact of HCV treatment initiation on health outcomes in injecting drug users Positive impact of HCV treatment initiation on health outcomes in injecting drug users Perrine ROUX, PhD Substance Use Research Center, Columbia University, NY Inserm U912, SE4S, Marseille Introduction

More information

The treatment of HIV is currently focused on drug

The treatment of HIV is currently focused on drug Vol 1 October 2009 Clinical Pharmacist 393 Since the advent of combination antiretroviral therapy in the mid-1990s HIV-infected individuals are now living longer with improved quality of life. Medication

More information

ARV treatment Update 2012. Avondseminarie 18 december 2012 Eric Florence ITG, Antwerpen

ARV treatment Update 2012. Avondseminarie 18 december 2012 Eric Florence ITG, Antwerpen ARV treatment Update 2012 Avondseminarie 18 december 2012 Eric Florence ITG, Antwerpen Three big conferences in 2012 http://retroconference.org/2012/ http://www.aids2012.org/ http://www.hiv11.com/ Current

More information

Aktuell HIV-forskning 2014-05-06

Aktuell HIV-forskning 2014-05-06 Aktuell HIV-forskning 2014-05-06 Alexey Kashpersky Aktuell HIV-forskning Bot Smittsamhet Nya läkemedel HIV och åldrande Etc HPTN 052 Prevention Conclusion Early ART that suppresses viral replication led

More information

HBV screening and management in HIV-infected children and adolescents

HBV screening and management in HIV-infected children and adolescents HBV screening and management in HIV-infected children and adolescents Linda Aurpibul M.D. Research Institute for Health Sciences, Chiang Mai University 8% HIV and Hepatitis B Co-infection Among Perinatally

More information

HIV/AIDS: Controversies 2008-10

HIV/AIDS: Controversies 2008-10 HIV/AIDS: Controversies 2008-10 1. Prevention 2. Treatment Josep M Gatell Hospital Clinic. Barcelona. gatell0@attglobal.net AIDS: year 2008-10 AIDS is a STD and a world wide epidemy (sub-saharan Africa,

More information

Boehringer Ingelheim- sponsored Satellite Symposium. HCV Beyond the Liver

Boehringer Ingelheim- sponsored Satellite Symposium. HCV Beyond the Liver Boehringer Ingelheim- sponsored Satellite Symposium HCV Beyond the Liver HCV AS A METABOLIC MODIFIER: STEATOSIS AND INSULIN RESISTANCE Francesco Negro University Hospital of Geneva Switzerland Clinical

More information

The Value of Innovation in HIV/AIDS Therapy

The Value of Innovation in HIV/AIDS Therapy White Paper September 2014 The Value of Innovation in HIV/AIDS Therapy Erin Ellwanger, Harrison Kim, and Thomas Goss, PharmD Boston Healthcare Associates, Inc. Boston; Washington, D.C.; Berlin; Shangai;

More information

Hepatitis Update. Study 110: SVR at post-treatment week 24 (SVR24) Jürgen Rockstroh, MD. No ART EFV/TDF/FTC ART/r/TDF/FTC Total

Hepatitis Update. Study 110: SVR at post-treatment week 24 (SVR24) Jürgen Rockstroh, MD. No ART EFV/TDF/FTC ART/r/TDF/FTC Total Hepatitis Update Jürgen Rockstroh, MD Study 11: SVR at post-treatment week 24 (SVR24) Patients with Undetectable HCV RNA (Percentage) 8 7 6 5 4 3 2 1 71 No ART EFV/TDF/FTC ART/r/TDF/FTC Total 69 8 74 n/n

More information

The use of alcohol and drugs and HIV treatment compliance in Brazil

The use of alcohol and drugs and HIV treatment compliance in Brazil The use of alcohol and drugs and HIV treatment compliance in Brazil André Malbergier, MD, PhD Hospital das Clínicas Medical School University of São Paulo Brasil The Casa da AIDS offers specialized integral

More information

Understanding Pharmacokinetic Variability and Managing Drug Interactions

Understanding Pharmacokinetic Variability and Managing Drug Interactions Understanding Pharmacokinetic Variability and Managing Drug Interactions Courtney V. Fletcher, Pharm.D. Dean, College of Pharmacy Professor, Department of Pharmacy Practice and Division of Infectious Diseases

More information

Amin Khademi 1, R. Scott Braithwaite 2,3, Denis Saure 4, Andrew J. Schaefer 5, Kimberly Nucifora 3, Mark S. Roberts 5,6,7 * Abstract

Amin Khademi 1, R. Scott Braithwaite 2,3, Denis Saure 4, Andrew J. Schaefer 5, Kimberly Nucifora 3, Mark S. Roberts 5,6,7 * Abstract Should Expectations about the Rate of New Antiretroviral Drug Development Impact the Timing of HIV Treatment Initiation and Expectations about Treatment Benefits? Amin Khademi 1, R. Scott Braithwaite 2,3,

More information

HIV viral load, HIV treatment and sexual HIV transmission

HIV viral load, HIV treatment and sexual HIV transmission FACTSHEET HIV viral load, HIV treatment and sexual HIV transmission Summary HIV viral load is the amount of HIV (or number of virus) in the bodily fluids of someone living with HIV. It is measured in the

More information

Recognizing the Value of Innovation in HIV/AIDS Therapy

Recognizing the Value of Innovation in HIV/AIDS Therapy White Paper December 2012 Recognizing the Value of Innovation in HIV/AIDS Therapy Catherine Augustyn, Brigham Walker, and Thomas F. Goss, PharmD Boston Healthcare Associates, Inc., Boston, MA and Washington,

More information

Vaccination and Enrollment Are Discontinued in Phase II Trials of Merck's Investigational HIV Vaccine Candidate

Vaccination and Enrollment Are Discontinued in Phase II Trials of Merck's Investigational HIV Vaccine Candidate News Release FOR IMMEDIATE RELEASE Merck Contact: Mary Elizabeth Blake (215) 652-5558 Merck Investor Contact: Graeme Bell (908) 423-5185 HVTN Contact: Sarah Alexander (206) 910-3801 Vaccination and Enrollment

More information

Xavière Panhard and France Mentré. INSERM U738 - CHU Bichat Claude Bernard. Xavière Panhard - INSERM U738-16/06/05 p. 1

Xavière Panhard and France Mentré. INSERM U738 - CHU Bichat Claude Bernard. Xavière Panhard - INSERM U738-16/06/05 p. 1 Non-linear mixed-effects models for tests of interaction or of lack of interaction in cross-over and parallel pharmacokinetic studies: application to the test of interaction between protease inhibitors

More information

Antenatal Guidelines. No.25 HIV screening and Management of HIV positive women

Antenatal Guidelines. No.25 HIV screening and Management of HIV positive women Antenatal Guidelines No.25 HIV screening and Management of HIV positive women 1. Introduction All pregnant women should be recommended an HIV screening test at an early stage in pregnancy or as soon as

More information

Case Finding for Hepatitis B and Hepatitis C

Case Finding for Hepatitis B and Hepatitis C Case Finding for Hepatitis B and Hepatitis C John W. Ward, M.D. Division of Viral Hepatitis Centers for Disease Control and Prevention Atlanta, Georgia, USA Division of Viral Hepatitis National Center

More information

VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral.

VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral. VIH/SIDA en Pediatría: Epidemiología Mundial, Transmisión Perinatal, Manejo Integral. Juan Carlos Salazar, M.D. Universidad de Connecticut, EE.UU. End-1998 global estimates Children (

More information

1 Appendix B: DESCRIPTION OF HIV PROGRESSION SIMULATION *

1 Appendix B: DESCRIPTION OF HIV PROGRESSION SIMULATION * 1 Appendix B: DESCRIPTION OF HIV PROGRESSION SIMULATION * Our simulation separately tracks the number of accumulated genetic mutations that may confer resistance to each of the three main drug categories

More information

The studies reported in this thesis were performed at the department of Viroscience of the Erasmus Medical Center, Rotterdam, the Netherlands.

The studies reported in this thesis were performed at the department of Viroscience of the Erasmus Medical Center, Rotterdam, the Netherlands. The studies reported in this thesis were performed at the department of Viroscience of the Erasmus Medical Center, Rotterdam, the Netherlands. This research was supported by the Aids Fonds, Netherlands

More information

Hepatitis C Vaccines: Are we making progress?

Hepatitis C Vaccines: Are we making progress? Hepatitis C Vaccines: Are we making progress? Second International Hepatitis Cure and Eradication Meeting. Vancouver November, 2015 Objectives: Review the need for a preventive vaccine in 2015. Identify

More information

Molecular Diagnosis of Hepatitis B and Hepatitis D infections

Molecular Diagnosis of Hepatitis B and Hepatitis D infections Molecular Diagnosis of Hepatitis B and Hepatitis D infections Acute infection Detection of HBsAg in serum is a fundamental diagnostic marker of HBV infection HBsAg shows a strong correlation with HBV replication

More information

The Genetic Basis of HIV-1 Resistance to Reverse Transcriptase and Protease Inhibitors

The Genetic Basis of HIV-1 Resistance to Reverse Transcriptase and Protease Inhibitors AIDS Rev 2000; 2: 211-228 Robert W. Shafer et al.: The genetic basis of HIV-1 resistance to reverse transcriptase and protease inhibitors The Genetic Basis of HIV-1 Resistance to Reverse Transcriptase

More information