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`
`World Health
`Organization
`
`CONSOLIDATED GUIDELINES ON
`THE USE OF
`ANTIRETROVIRAL DRUGS
`FOR TREATING AND
`PREVENTING HIV INFECTION
`
`RECOMMENDATIONS FOR A PUBLIC HEALTH APPROACH
`
`JUNE2013
`
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`

`
`WHO Library Cataloguing-in-Publication Data
`
`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing
`HIV infection: Recommendations for a public health approach June 2013.
`
`1.HIV infections - drug therapy. 2.HIV infections - prevention and control.
`3.Anti-Retroviral agents - therapeutic use. 4.Guideline. I.World Health Organization.
`
`ISBN 978 92 4 150572 7
`
`(NLM classification: WC 503.2)
`
`© World Health Organization 2013
`
`All rights reserved. Publications of the World Health Organization are available on
`the WHO web site (www.who.int) or can be purchased from WHO Press, World
`Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland
`(tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders©who.int).
`
`Requests for permission to reproduce or translate WHO publications -whether
`for sale or for noncommercial distribution - should be addressed to WHO Press
`through the WHO web site (http:llwww.who.intlaboutllicensinglcopyright_forml
`en/index.html).
`
`The designations employed and the presentation of the material in this publication
`do not imply the expression of any opinion whatsoever on the part of the World
`Health Organization concerning the legal status of any country, territory, city
`or area or of its authorities, or concerning the delimitation of its frontiers or
`boundaries. Dotted lines on maps represent approximate border lines for which
`there may not yet be full agreement.
`
`The mention of specific companies or of certain manufacturers’ products does not
`imply that they are endorsed or recommended by the World Health Organization
`in preference to others of a similar nature that are not mentioned. Errors and
`omissions excepted, the names of proprietary products are distinguished by initial
`capital letters.
`
`All reasonable precautions have been taken by the World Health Organization
`to verify the information contained in this publication. However, the published
`material is being distributed without warranty of any kind, either expressed or
`implied. The responsibility for the interpretation and use of the material lies with
`the reader. In no event shall the World Health Organization be liable for damages
`arising from its use.
`
`Design and layout by ACW, London
`
`Re-printed in November 2013 with changes.
`
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`-’--’-----CONTENTS
`
`Abbreviations and acronyms
`
`Acknowledgements
`
`Foreword
`
`Executive summary
`
`Summary of new recommendations
`
`Introduction
`
`1.1
`
`1.2
`
`1.3
`
`1.4
`
`1.5
`
`Background and context
`
`Rationale for consolidated guidelines
`
`Objectives
`
`Target audience
`
`Scope and components
`
`1.5.1
`
`1.5.2
`
`1.5.3
`
`1.5.4
`
`1.5.5
`
`Introductory chapters
`
`Clinical guidance
`
`Operational and service delivery guidance
`
`Guidance for programme managers
`
`Monitoring and evaluation
`
`Guiding principles
`
`2.1
`
`2.2
`
`2.3
`
`2.5
`
`2.6
`
`Contribution to global health goals
`
`Public health approach
`
`Strengthening health systems through innovation and learning
`
`Promoting human rights and health equity
`
`Implementation based on local context
`
`Methods and process for developing the guidelines
`
`3.1
`
`3.2
`
`3.3
`
`Overview
`
`Information sources
`
`External participation
`
`3.3.1 Guideline Development Groups and peer review process
`
`Contents
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`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`3.3.2
`
`Process of formulating recommendations
`
`Other methods
`
`Dissemination
`
`3.4
`
`3.5
`
`3.6
`
`Organization of the guidelines
`
`Continuum of care
`
`4.1
`
`4.2
`
`Structure of presentation for new recommendations
`
`Structure of presentation of selected recommendations
`from existing guidelines
`
`4.3.1
`
`4.3.2
`
`Pregnant and breastfeeding women
`
`Adolescents ~
`
`4.3.3
`
`Children !{
`
`4.3.4
`
`Key populations ~
`
`Clinical guidelines across the continuum of care:
`HIV diagnosis and ARV drugs for HIV prevention
`
`5.1
`
`HIV testing and counselling
`
`5.1 .I
`
`5.1.2
`
`5.1.3
`
`5.1.4
`
`Introduction
`
`HIV testing and counselling in health facilities
`
`Community-based HIV testing and counselling
`
`HIV testing and counselling ~ ~:
`
`5.2
`
`HIV prevention based on ARV drugs
`
`5.2.1
`
`5.2.2
`
`5.2.3
`
`Oral pre-exposure oral prophylaxis
`
`ART for prevention among serodiscordant couples
`
`Post-exposure prophylaxis for occupational and
`non-occupational exposure to HIV
`
`5.2.4 Combination HIV prevention
`
`Clinical guidelines across the continuum of care:
`Linking people diagnosed with HIV infection
`to HIV care and treatment
`
`6.1 Introduction
`
`6.2
`
`6.3
`
`Good practices for linkage to care
`
`General care for people living with HIV
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`Contents
`
`Preparing people living with HIV for ART
`6.4
`¯ : " :’
`6.5 ’~’~’~
`.
`
`Clinical guidance across the continuum of care: Antiretroviral therapy
`
`7.1
`
`When to start ART
`
`7.1.1
`
`7.1.2
`
`7.1.3
`
`7.1.4
`
`When to start ART in adults and adolescents .~ ~
`
`When to start ART in pregnant and breastfeeding women
`
`ARV drugs and duration of breastfeeding ~
`
`When to start ART in children ~.~
`
`7.2 What ARV ~t:limel~ to ~t,:~It v~,ith ~fil~t-li~,:, ART)
`
`7.2.1
`
`7.2.2
`
`7.2.3
`
`7.2.4
`
`First-line ART for adults
`
`First-line ART for pregnant and breastfeeding women .,~
`and ARV drugs for their infants
`
`First-line ART for children younger than three years of age ~.~
`
`First-line ART for children three years and older
`(including adolescents)
`
`7.2.5 TB co-treatment in children ~ ~.~
`
`7.3
`
`Monitoring response to ART and the diagnosis of .~.~. ~ ~ ~..~,
`treatment failure
`
`7.3.1 Laboratory monitoring before and after initiating ART
`
`7.3.2
`
`Monitoring the response to ART and the diagnosis
`of treatment failure
`
`7.4
`
`Monitoring and substitutions for ARV drug toxicities ~ ~ ~
`
`7.4.1
`
`7.4.2
`
`7.4.3
`
`7.4.4
`
`7.4.5
`
`7.4.6
`
`Guiding principles
`
`Major types of ARV toxicities
`
`Monitoring TDF toxicity
`
`Toxicity monitoring for other ARV drugs
`
`Drug substitutions for ARV drug toxicity
`
`Key ARV drug interactions
`
`7.5 What ARV regimen to switch to (second-line ART)
`
`7.5.1 Second-line ART for adults and adolescents *~, ’~
`
`7.5.2 Second-line ART for children (including adolescents)
`
`7.6
`
`Third-lineART i~ ~ ~ ~
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`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`Clinical guidance across the continuum of care:
`Managing common coinfections and comorbidities
`
`8.1
`
`Prevention, screening and management of common coinfections
`
`8.1.1
`
`8.1.2
`
`8.1.3
`
`8.1.4
`
`8.1.5
`
`8.1.6
`
`8.1.7
`
`Co-trimoxazole preventive therapy
`
`Tuberculosis
`
`Cryptococcal infection
`
`Hepatitis B and C
`
`Malaria
`
`Sexually transmitted infections and cervical cancer
`
`Vaccines for people living with HIV
`
`8.2
`
`Preventing and managing other comorbidities and chronic care for
`people living with HIV
`
`8.2.1
`
`8.2.2
`
`8.2.3
`
`8.2.4
`
`8.2.5
`
`8.2.6
`
`Screening for and care of noncommunicable diseases
`
`Mental health
`
`Drug use and drug use disorders
`
`Nutritional care and support
`
`Palliative care: symptom management and end-of-life care
`
`Other relevant general guidance on care
`
`Guidance on operations and service delivery ~, ,~ ~ ~, ~
`
`9.1
`
`9.2
`
`Introduction
`
`Adherence to ART
`
`9.2.1
`
`9.2.2
`
`9.2.3
`
`Barriers to adherence
`
`Interventions to optimize adherence to ART
`
`Monitoring adherence to ART in routine programme
`and care settings
`
`9.3
`
`Retention across the continuum of care
`
`9.3.1
`
`9.3.2
`
`Background
`
`Good practices for retention across the continuum of care
`
`9.4
`
`Service delivery
`
`9.4.1
`
`9.4.2
`
`9.4.3
`
`Good practices in providing chronic care
`
`Integrating and linking services
`
`Decentralizing HIV treatment and care
`
`9.5
`
`Human resources
`
`9.5.1
`
`9.5.2
`
`Building human resource capacity
`
`Task shifting for HIV treatment and care
`
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`9.6
`
`Laboratory and diagnostic services
`
`9.6.1
`
`Overview
`
`9.6.2
`
`9.6.3
`
`9.6.4
`
`9.6.5
`
`9.6.6
`
`9.6.7
`
`Implementation considerations and good practices
`
`Strengthening and expanding laboratory and diagnostic services
`
`Supporting a dedicated specimen referral system
`
`Increasing access to HIV viral load testing
`
`Expanding diagnostic services to point-of-care settings
`
`Providing guidance for developing health workers’ capacity,
`
`9.6.8
`
`Implementing comprehensive quality management systems
`
`9.7
`
`Procurement and supply management systems
`
`9.7.1
`
`9.7.2
`
`9.7.3
`
`Overview
`
`Rationale and supporting evidence
`
`Implementation considerations and good practices
`
`10.
`
`Guidance for programme managers
`
`10.1
`
`Introduction
`
`10.2 Decision-making process
`
`10.3 Data to support decision-making
`
`10.3.1
`
`Overview
`
`10.3.2 National and local HIV epidemiology
`
`10.3.3
`
`Programme performance and response analysis
`
`10.3.4 Socioeconomic, policy and legal context
`
`10.4
`
`Key parameters for decision-making
`
`10.4.1
`
`Ethics, equity and human rights
`
`10.4.2
`
`Impact and cost-effectiveness
`
`10.4.3 Opportunities and risks
`
`10.5
`
`10.6
`
`Implementation considerations across the health system
`
`Implementation considerations for key recommendations
`
`Contents
`
`194 .......
`
`194 .................
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`195
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`19]
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`19]
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`19]
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`19]
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`19]
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`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
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`10.7
`
`Implementing recommendations in different contexts
`
`10.7.1 Overview
`
`10.7.2 Implementing recommendations in different epidemic settings
`
`10.8 Useful tools for costing and planning
`
`11. Monitoring and evaluation
`
`11.1
`
`Introduction
`
`11.2 Monitoring implications of new recommendations
`
`11.3 Monitoring the outputs and outcomes of scaling up access to ARVdrugs
`
`11.4 Other monitoring considerations
`
`11.4.1
`
`HIV drug resistance
`
`11.4.2
`
`11.4.3
`
`Sentinel surveillance for ARV toxicity monitoring
`
`Evaluation, including impact and programme performance,
`and implementation research
`
`11.5 Reviewing and strengthening monitoring and evaluation systems
`
`12.
`
`Annexes
`
`Annex I.
`
`Annex 2.
`
`WHO clinical staging of HIV disease
`in adults, adolescents and children ~ ~ ~~,’g
`
`Algorithm for the 2013 recommendations
`for adults and adolescents
`
`Annex 3.
`
`Algorithm for the 2013 recommendations
`for pregnant and breastfeeding women ~
`
`Annex 4.
`
`Algorithm for the 2013 recommendations for children ~.
`
`Annex 5.
`
`Annex 6.
`
`Algorithm for early infant diagnosis ~.
`
`Readiness assessment checklist: moving towards
`ART for pregnant and breastfeeding women
`
`Annex 7.
`
`Dosages of recommended antiretroviral drugs
`
`13. References
`
`~
`]~, ~ -~i~
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`e.. BBREVIATIONS AND AC RONYMS
`
`Abbreviations and acronyms
`
`3TC
`
`ABC
`
`AIDS
`
`ART
`
`ARV
`
`ATV
`
`lamivudine
`
`abacavir
`
`antiretroviral therapy
`
`antiretroviral (drug)
`
`atazanavir
`
`ATV/r
`
`atazanavirlritonavir
`
`AZT
`
`BMI
`
`CD4
`
`CDC
`
`CNS
`
`d4T
`
`zidovudine (also known as ZDV)
`
`body mass index
`
`T-lymphocyte cell bearing CD4 receptor
`
`United States Centers for Disease Control and Prevention
`
`central nervous system
`
`stavudine
`
`DALYs
`
`death- and disability-adjusted life-years
`
`DBS
`
`ddl
`
`DNA
`
`DRV
`
`dried blood spot
`
`didanosine
`
`deoxyribonucleic acid
`
`darunavir
`
`DRVIr
`
`darunavirlritonavir
`
`EFV
`
`eGFR
`
`ELISA
`
`ETV
`
`FPV
`
`FPVIr
`
`FTC
`
`GNP+
`
`efavirenz
`
`enzyme-linked immunosorbent assay
`
`etravirine
`
`fosamprenavir
`
`fosamprenavirlritonavir
`
`emtricitabine
`
`Global Network of People Living with HIV
`
`GRADE
`
`Grading of Recommendations Assessment, Development and Evaluation
`
`HBsAg
`
`hepatitis B surface antigen
`
`hepatitis B virus
`
`hepatitis C virus
`
`HBV
`
`HCV
`
`HIV
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`
`Consolidated
`
`guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`HPTN
`
`HIV Prevention Trials Network
`
`herpes simplex virus
`
`isoniazid
`
`isoniazid preventive therapy
`
`lopinavir
`
`lopinavirlritonavir
`
`multidrug-resistant TB, resistant to at least isoniazid and rifampicin
`
`mother-to-child transmission (of HIV)
`
`HSV
`
`INH
`
`IPT
`
`IRIS
`
`LPV
`
`LPV/r
`
`MDR
`
`MTCT
`
`NFV
`
`NNRTI
`
`non-nucleoside reverse-transcriptase inhibitor
`
`NRTI
`
`NVP
`
`OST
`
`PCR
`
`PI
`
`PICO
`
`nucleoside reverse-transcriptase inhibitor
`
`nevirapine
`
`opioid substitution therapy
`
`polymerase chain reaction
`
`protease inhibitor
`
`Population, Intervention, Comparison and Outcomes
`
`PCP/PJP
`
`Pneurnocystis (jirovecii) pneumonia
`
`PMTCT
`
`prevention of mother-to-child transmission of HIV
`
`PrEP
`
`RAL
`
`RBV
`
`RIF
`
`RNA
`
`RTV
`
`pre-exposure prophylaxis of HIV
`
`raltegravir
`
`ribavirin
`
`rifampicin
`
`ribonucleic acid
`
`ritonavir
`
`sd-NVP
`
`single-dose nevirapine
`
`TAM
`
`TB
`
`TDF
`
`TPV
`
`thymidine analogue mutation
`
`tuberculosis
`
`tenofovir disoproxil fumarate
`
`tipranavir
`
`UNAIDS
`
`Joint United Nations Programme on HIV/AIDS
`
`UNICEF
`
`United Nations Children’s Fund
`
`UNODC
`
`WHO
`
`World Health Organization
`
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`Definition of key terms
`
`DEFINITION OF KEY TERMS
`
`GENERAL
`
`HIV-I is responsible for the vast majority of HIV infections globally. Within these guidelines,
`
`AGE GROUPS AND POPULATIONS
`
`consistency within these consolidated guidelines, as well as with other WHO guidelines. It is
`
`an adult at an earlier age.
`
`An adolescent is a person aged 10 to 19 years inclusive.
`
`an earlier age. However, in these guidelines when a person falls into the 10 to 19 age category
`
`An infant is a child younger than one year of age.
`
`~i-=es~ 9(li(t~:,lil~e~ (lefiI~e key populations to include both vulnerable and most-at-risk
`populations. They are important to the dynamics of HIV transmission in a given setting and
`are essential partners in an effective response to the epidemic. People living with HIV are
`considered a key population in all epidemic contexts.
`
`[D~se ~li~i, lilies ~[i~/~ most-at-risk populations as men who have sex with men,
`transgender people, people who inject drugs and sex workers. Most-at-risk populations are
`disproportionately affected by HIV in most, if not all, epidemic contexts.
`
`Vulnerable populations are groups of people who are particularly vulnerable to HIV infection
`in certain situations or contexts, such as adolescents (particularly adolescent girls), orphans,
`street children, people in closed settings (such as prisons or detention centres), people
`
`populations that are particularly vulnerable and key to their epidemic and response based on
`the epidemiological and social context.
`
`Serodiscordant couples are couples in which one partner is living with HIV and the other is
`HIV-negative. A couple refers to two people in an ongoing sexual relationship; each of these
`
`considerably according to cultural and social context.
`
`HEALTH CARE SERVICES
`Continuum of HIV care refers to a comprehensive package of HIV prevention, diagnostic,
`treatment and support services provided for people living with HIV and their families ranging
`across: initial HIV diagnosis and linkage to care; management of opportunistic infections and
`other comorbid conditions; initiating, maintaining and monitoring ART; switching to second-
`line and third-line ART; and palliative care.
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`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`A public health approach addresses the health needs of a population or the collective
`health status of the people rather than just individuals. A public health approach involves
`a collaborative effort by all parts of the health sector, working to ensure the well-being
`of society through comprehensive prevention, treatment, care and support. For HIV, this
`
`treatment for adults and children; care and drugs given free at the point of service delivery;
`
`toxicity monitoring.
`
`HIV TESTING AND PREVENTION
`Voluntary counselling and testing (also referred to as client-initiated testing and
`counselling) describes a process initiated by an individual who wants to learn his or her
`HIV status. Since there are now many different community approaches to providing HIV
`testing and counselling and people often have mixed motivations for seeking testing (both
`recommended by a provider and sought by a client), WHO prefers to use the term HIV testing
`and counselling. All forms of HIV testing and counselling should be voluntary and adhere
`
`care, treatment and prevention services. Quality assurance of both testing and counselling is
`essential in all approaches to HIV testing and counselling.
`
`Provider-initiated testing and counselling is HIV testing and counselling recommended by
`a health-care provider in a clinical setting. Provider-initiated testing and counselling, as with all
`
`Combination prevention refers to a combination of behavioural, biomedical and structural
`approaches to HIV prevention to achieve maximum impact on reducing HIV transmission and
`acquisition.
`
`ART (ANTIRETROVIRAL THERAPY)
`
`ARV {antiretroviral) drugs refer to the medicines themselves and not to their use.
`
`ART refers to the use of a combination of three or more ARV drugs to achieve viral suppression.
`This generally refers to lifelong treatment. Synonyms are combination ART and highly active
`ART.
`
`ART for prevention " "~~ ~., ~r ,. ,~,
`
`Eligible for ART refers to people living with HIV for whom ART is indicated according to the
`
`often used interchangeably with "needing treatment", although this implies an immediate risk
`or an obligation to initiate treatment.
`
`Viral suppression refers to the aim of ART to maintain viral load below the level of detection
`of available assays, generally less than 50 copies per ml. The current WHO virological criterion
`for treatment failure is 1000 copies per ml or more.
`
`Universal access to ART is ,’t~:,fifl~:,(J t;~o~t,:ty ~s ~t i~=ow to ~ I~igt~ k~wl of 4cc~s,, {~,80% of
`the eligible population) for the most effective interventions that are equitable, accessible,
`affordable, comprehensive and sustainable over the long term; this does not necessarily mean
`100% coverage.
`
`Lupin Ex. 1066 (Page 13 of 271)
`
`

`
`Definition of key terms
`
`HEALTH WORKFORCE
`
`Community health workers are health workers who have received standardized and
`nationally endorsed training outside the nursing, midwifery or medical curricula.
`
`Midwives are people trained to assist in childbirth, including registered and enrolled
`midwives.
`
`Non-physician clinicians are professional health workers capable of many of the
`diagnostic and clinical functions of a physician but who are not trained as physicians.
`These types of health workers are often known as health officers, clinical officers,
`physician assistants, nurse practitioners or nurse clinicians.
`
`Nurses include professional nurses, enrolled nurses, auxiliary nurses and other nurses
`such as dental or primary care nurses.
`
`EPIDEMIOLOGY
`
`Concentrated HIV epidemic: HIV has spread rapidly in one or more defined
`subpopulation but is not well established in the general population. Numerical proxy: HIV
`prevalence is consistently over 5% in at least one defined subpopulation but is less than
`1% among pregnant women in urban areas.
`
`Generalized HIV epidemic: HIV is firmly established in the general population.
`Numerical proxy: HIV prevalence consistently exceeding 1% among pregnant women. Most
`generalized HIV epidemics are mixed in nature, in which certain (key) subpopulations are
`disproportionately affected.
`
`Mixed epidemics: people are acquiring HIV infection in one or more subpopulations
`and in the general population. Mixed epidemics are therefore one or more concentrated
`epidemics within a generalized epidemic.
`
`Low-level epidemic: epidemics in which the prevalence of HIV infection has not
`consistently exceeded 1% in the general population nationally or 5% in any subpopulation.
`
`Low-, moderate- and high-uptake ART settings refer to settings in which the uptake
`of ART among those eligible for ART is less than 50%, 50-80% and greater than 80%,
`respectively.
`
`Lupin Ex. 1066 (Page 14 of 271)
`
`

`
`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`A setting with a high burden of TB and HIV refers to settings with adult HIV
`prevalence :~1% or HIV prevalence among people with TB ~.~5%.
`
`HIV incidence is the number of new people acquiring HIV infection in a given period in a
`specified population.
`
`HIV prevalence refers to the number of people living with HIV at a specific point in time
`and is expressed as a percentage of the population.
`
`PMTCT (PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV)
`In these guidelines, WHO is moving away from the previous terms "Options A, B and
`B+". Instead, these guidelines recommend two options: (i) providing lifelong ART to all
`pregnant and breastfeeding women living with HIV regardless of CD4 count or clinical
`stage or (ii) providing ART (ARV drugs) for pregnant and breastfeeding women with HIV
`during the mother-to-child transmission risk period and then continuing lifelong ART
`for those women eligible for treatment for their own health. In settings that are not
`implementing lifelong ART for all pregnant and breastfeeding women living with HIV,
`the distinction between prophylaxis (ARV drugs given for a limited time during the risk
`period for transmitting HIV from mother to child to prevent this) and treatment (ART given
`both for the mother’s health, based on current adult eligibility, and to prevent vertical
`transmission) is still important.
`
`ARV drugs for women living with HIV during pregnancy and breastfeeding refers
`to a triple-drug ARV drug regimen provided to mothers living with HIV primarily as
`prophylaxis during pregnancy and throughout breastfeeding (when there is breastfeeding)
`to prevent mother-to-child transmission of HIV. In this option, the mother’s regimen is
`continued lifelong after delivery or after the breastfeeding ends only if she meets the ART
`eligibility criteria for her own health based on CD4 count or clinical stage. Previous WHO
`guidance referred to this as option B.
`
`Lifelong ART for all pregnant and breastfeeding women living with HIV refers
`to the approach in which all pregnant women living with HIV receive a triple-drug ARV
`regimen regardless of CD4 count or clinical stage, both for their own health and to prevent
`vertical HIV transmission and for additional HIV prevention benefits. Previous WHO
`guidance referred to this as option B+.
`
`Lupin Ex. 1066 (Page 15 of 271)
`
`

`
`Acknowledgements
`
`A
`
`Anthony Harries (International Union against Tuberculosis and Lung Disease, United
`Kingdom) and Gottfried Hirnschall (Department of HIV, World Health Organization)
`co-chaired the guidelines process.
`
`Adult Guideline Development Group
`Co-chairs: Serge Eholie (ANEPA/Treichville Hospital, Abidjan, CGte d’lvoire) and Stefano
`Vella (Istituto Superiore di SanitY, Italy).
`
`GRADE methodologist: Elie Akl (American University of Beirut, Lebanon).
`
`Pedro Cahn (FundaciGn Huesped, Argentina), Alexandra Calmy (University of Geneva,
`Switzerland), Frank Chimbwandira (Ministry of Health, Malawi), David Cooper (University
`of New South Wales and St Vincent’s Hospital, Australia), Judith Currier (UCLA Clinical AIDS
`Research & Education Center, USA), Fran~;ois Dabis (School of Public Health (ISPED), University
`Bordeaux Segalen, France), Charles Flexner (Johns Hopkins University, USA), Beatriz
`Grinsztejn (Funda~;~o Oswaldo Cruz (FIOCRUZ), Brazil), Diane Havlir (University of California
`at San Francisco, USA), Charles Holmes (Centre for Infectious Disease Research in Zambia,
`Zambia), John Idoko (National Agency for the Control of AIDS, Nigeria), Kebba Jobarteh
`(Centers for Disease Control and Prevention, Mozambique), Nagalingeswaran Kumarasamy
`(Y.R. Gaitonde Centre for AIDS Research and Education, India), Volodymyr Kurpita (All-
`Ukrainian Network of People Living with HIV, Ukraine), Karine Lacombe (Agence Nationale
`de Recherche sur le Sida et les H~patites Virales (ANRS), France), Albert Mwango (Ministry
`of Health, Zambia), Leonardo Palombi (DREAM Program, Community of Sant’Egidio, Rome,
`Italy), Anton Pozniak (Chelsea and Westminster Hospital, United Kingdom), Luis Adrian
`Quiroz (Derechohabientes Viviendo con VlH del IMSS (DVlMSS), Mexico), Kiat Ruxrungtham
`(Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thailand), Michael Saag
`(University of Alabama at Birmingham, USA), Gisela Schneider (German Institute for Medical
`Mission, Germany), Yanri Subronto (Universitas Gadjah Mada, Indonesia) and Francois
`Venter (University of the Witwatersrand, South Africa).
`
`Maternal and Child Health Guideline Development Group
`
`Co-chairs: Elaine Abrams (International Center for AIDS Care and Treatment Programs
`(ICAP), Columbia University, USA) and Denis Tindyebwa (African Network for the Care of
`Children Affected by AIDS, Uganda).
`
`GRADE methodologist: Joerg Meerpohl (German Cochrane Centre, University Medical
`Center, Freiburg, Germany).
`
`Renaud Becquet (Internationale Institut de Sant~ Publique d’Epid~miologie et de
`D~veloppement, Universit~ Bordeaux Segalen, France), Deborah Birx (United States
`Centers for Disease Control and Prevention, USA), Benjamin Chi (Centre for Infectious
`Disease Research in Zambia, Zambia), Mark Cotton (Stellenbosch University, South Africa),
`Nonhlanhla Dlamini (National Department of Health, South Africa), Ren~ Ekpini (United
`Nations Children’s Fund, USA), Carlo Giaquinto (Paedatric Infectious Disease Unit and
`Clinical Trials Unit of Azienda Ospedaliera di Padua, Italy), Diana Gibb (Medical Research
`Council Clinical Trials Unit, United Kingdom), Sabrina Bakeera-Kitaka (Makerere University
`and Mulago National Referral Hospital, Uganda), Louise Kuhn (Columbia University, USA),
`Evgenia Maron (Charitable Women’s Foundation Astra, Russian Federation),
`Babalwa Mbono (mothers2mothers, South Africa), James Mclntyre (University of Cape
`
`Lupin Ex. 1066 (Page 16 of 271)
`
`

`
`Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
`
`Town, South Africa), Lynne Mofenson (National Institutes of Health, USA), Angela Mushavi
`(Ministry of Health and Child Welfare, Zimbabwe), Ryan Phelps (United States Agency for
`International Development, USA), Jorge Pinto (Federal University of Minas Gerais, Brazil),
`Andrew Prendergast (Queen Mary University of London, United Kingdom), Thanyawee
`Puthanakit (Chulalongkorn University, Thailand), Atiene Sagay (Unversity of Jos, Nigeria),
`Roger Shapiro (Harvard School of Public Health, USA), George Siberry (National Institutes
`of Health, USA), Landry Tsague (United Nations Children’s Fund, Zambia), Thorkild Tylleskar
`(University of Bergen, Norway), Paula Vaz (Funda~o Ariel Glaser contra o SIDA Pedi~trico,
`Mozambique), Evgeny Voronin (Russian AIDS Pediatric Center, Russian Federation) and
`Linhong Wang (Chinese Center for Disease Control and Prevention, China).
`
`Operational and Service Delivery Guideline Development Group
`
`Co-chairs: Kevin De Cock (United States Centers for Disease Control and Prevention, USA)
`and Yogan Pillay (National Department of Health, South Africa).
`
`GRADE methodologist: Holger Schiinemann (Faculty of Health Sciences, McMaster
`University, Canada).
`
`Tsitsi Mutasa Apollo (Ministry of Health and Child Welfare, Zimbabwe), Yibletal Assefa
`(Ministry of Health, Ethiopia), Paula Braitstein (Indiana University School of Medicine,
`USA), Zengani Chirwa (Ministry of Health, Malawi), Bui Duc Duong (Ministry of Health,
`Viet Nam), Ade Fakoya (Global Fund to Fight AIDS, Tuberculosis and Malaria, Switzerland),
`Robert Ferris (United States Agency for International Development, USA), Ronaldo Hallal
`(Departamento de DST, Aids e Hepatites Virais, Brazil), Eihab Ali Hassan (Federal Ministry
`of Health, Sudan), David Hoos (International Centre for AIDS Care and Treatment Programs,
`Columbia University, USA), Barbara Milani (M~decins Sans Fronti~res (MSF), Switzerland),
`Christine Nabiryo (The AIDS Support Organization (TASO), Uganda), Natalia Nizova
`(Ministry of Health, Ukraine), Anupam Pathni (International Planned Parenthood Federation
`South Asia, India), Elliot Raizes (United States Centers for Disease Control and Prevention,
`USA), Kenly Sekwese (Treatment Advocacy Literacy Campaign, Zambia), Larissa Stabinski
`~f~e .’~ ~t~ !]~li~’~J ~t~:~ ’/~1~;/~1 ,<"~II~S t.~;~Jk~.-’.l.~~ !Jl:;,<"~; Miriam Taegtmeyer (Liverpool
`School of Tropical Medicine, United Kingdom), Wim Van Damme (Institute of Tropical
`Medicine, Belgium), Eric van Praag (Family Health International (FHI), United Republic of
`Tanzania), Mean Chhi Vun (Ministry of Health, Cambodia), Larry Westerman (United States
`Centers for Disease Control and Prevention, USA), Steve Wignall (Clinton Health Access
`Initiative (CHAI), Indonesia) and Anna Zakowicz (Global Network of People Living with HIV
`(GNP+), Europe).
`
`Programmatic Guideline Development Group
`
`Co-chairs: Tsitsi Apollo (Ministry of Health and Child Welfare, Zimbabwe) and Adeeba
`Kamarulzaman (University of Malaya, Malaysia).
`
`Ihab Abdelrahman (Ministry of Health and Population, Egypt), John Aberle-Grasse (United
`States Centers for Disease Control and Prevention, USA), Yibeltal Assefa (Ministry of
`Health, Ethiopia), Rob Baltussen (Radboud University Nijmegen, Netherlands), Anton Best
`(Ministry of Health, Barbados), John Blandford (United States Centers for Disease Control and
`Prevention, USA), Sergiy Filippovych (International HIV/AIDS Alliance in Ukraine, Ukraine),
`Eric Goemaere (M~decins Sans Fronti~res (MSF), South Africa), Dirceu Greco (Ministry of
`Health, Brazil), Timothy Hallett (Imperial College London, United Kingdom), Priscilla Idele
`(United Nations Children’s Fund, USA), Ushma Mehta (Independent Consultant, South Africa),
`Irene Mukui (National AIDS & STI Control Programme, Kenya), Jean Paul Moatti (French
`National Institute of Health and Medical Research (INSERM), Universit~ de la M~diterran~e,
`France), Natalia Nizova (Ministry of Health, Ukraine), Ole Frithjof Norheim (University
`
`Lupin Ex. 1066 (Page 17 of 271)
`
`

`
`Acknowledgements
`
`of Bergen, Norway), Asia Russell (Health GAP, USA), Kenly Sikwese (Positive Health
`Outcomes, Zambia), Jerome Singh (Centre for the AIDS Programme of Research in South
`Africa, South Africa), Petchsri Sirinirund (Ministry of Public Health, Thailand), John Stover
`(Futures Institute, USA), Aliou Sylla (Ministry of Health, Mali), Wim Van Damme (Institute
`of Tropical Medicine, Belgium), Stefan Weinmann (Deutsche Gessellschaft fur Internationale
`Zusammenarbeit (GIZ) GmbH, Germany) and Annemarie M. J. Wensing (University Medical
`Centre Utrecht, Netherlands).
`
`Observer at the Programmatic Guideline Development Group meeting: Bernhard
`Schwartl~nder (UNAIDS, Switzerland).
`
`External peer reviewers
`
`Michelle Adler (United States Centers for Disease Control and Prevention, USA), Isabelle
`Andrieux-Meyer (M~decins Sans Fronti~res, Switzerland), Xavier Anglaret (Programme
`PACCI du site ANRS de C6te d’lvoire, C6te d’lvoire), Marcelo Araujo de Freitas (Ministry
`of Health, Brazil), Pamela Bachanas (United States Centers for Disease Control and
`Prevention, USA), Shaiful Bahari Ismail (Universiti Sains Malaysia, Malaysia), Pierre
`Barker (University of North Carolina at Chapel Hill, USA), David Barr (HIV Collaborative
`Fund at Tides Center, USA), Jose Gerard Belimac (National AIDS and STI Prevention and
`Control Program, Philippines), Soumia