Anal Cancer Screening Guidelines for PLHIV
Introduction
Overview
All anal cancer screening should include
The recommendations in these guidelines
These guidelines are intended
Methods
Populations to screen
Annual age-standardised anal cancer incidence
Anal cancer incidence per 100000
Age-specific anal cancer incidence
Possible anal cancer screening methods
High risk HPV (HRHPV) testing
Anal Cytology
Performance of screening tools
The IANS guidelines for ASCC screening
Screening Intervals and Cessation
The implementation of any recommendations
Key recommendations
All anal cancer screening should include
As anal cancer screening and HRA capacity
Proposed screening algorithm
Definitions
Management of screening test results
Where HRA services are available
Where HRA services are not available
Frequency and management of HPV screening
Abbreviations
Notes
Anal HSIL treatment
Ablative treatments
Topical treatments
HPV Vaccination
General advice
Useful links & References
Useful Links
References
Appendix
Australian Modified Bethesda System for reporting anal cytology
Acknowledgements
HIV Guidelines
HIV Treatment and Management
Adult ARVs
Home
What’s New in the Guidelines?
When do updates occur?
April 2025
June 2024
July 2023
Introduction
Baseline Evaluation
References
Laboratory Testing
Tests for Initial Assessment and Follow-Up
Laboratory Testing for Initial Assessment and Monitoring of People with HIV Receiving Antiretroviral Therapy
Laboratory Testing Schedule for Monitoring People with HIV Before and After Initiation of Antiretroviral Therapy
References
Plasma HIV-1 RNA (Viral Load) and CD4 Count Monitoring
Use of CD4 Count for Initial Assessment
Use of CD4 Count for Monitoring Therapeutic Response
Frequency of CD4 Count Monitoring
Factors that Affect Absolute CD4 Count
References
Drug-Resistance Testing
Genotypic and Phenotypic Resistance Assays
Genotypic Assays
Phenotypic Assays
Limitations of Genotypic and Phenotypic Assays
Use of Resistance Assays in Determining Initial Treatment
Use of Resistance Assays in the Event of Virologic Failure
Use of HIV Proviral DNA Resistance Assays for Optimizing Antiretroviral Regimen in People With Viral Suppression
Use of Resistance Assays in Pregnancy
Recommendations for the Use of Drug-Resistance Assays
References
Co-receptor Tropism Assays
References
HLA-B* 5701 Screening
References
Treatment Goals
Strategies to Achieve Treatment Goals
References
Initiation of Antiretroviral Therapy
Introduction
Initiating Antiretroviral Therapy
Immediate Antiretroviral Therapy Initiation on the Day of HIV Diagnosis
Antiretroviral Therapy for Persons with Acute Opportunistic Infections and Malignancies
Evidence Supporting the Benefits of Antiretroviral Therapy in Preventing Morbidity and Mortality
Use of Antiretroviral Therapy to Prevent HIV Transmission
Considerations When Initiating Antiretroviral Therapy
Considerations for Special Populations
References
ART to Prevent Sexual Transmission of HIV
Evidence that Viral Load Suppression Prevents Sexual HIV Transmission
Integrating the Principles of Treatment as Prevention into Clinical Care
Treatment as Prevention Applies Only to Sexual Transmission of HIV
References
What to Start
Initial Combination ARV Regimens for People with HIV
Introduction
Recommended Initial Regimens for Most People With HIV
Other Initial Antiretroviral Regimens for Certain Clinical Scenarios
Changes Since the Last Revision of the Guidelines
INSTI-Based Regimens
PI-Based Regimens
NNRTI-Based Regimens
Regimens When Abacavir, Tenofovir Alafenamide, and Tenofovir Disoproxil Fumarate Cannot Be Used or Are Not Optimal
References
Selecting an ART Regimen
Nucleoside Reverse Transcriptase Inhibitor
Summary
Clinical Trials Comparing Nucleoside Reverse Transcriptase Inhibitors
Nucleoside Reverse Transcriptase Inhibitor Options for Initial Therapy
References
Integrase Strand Transfer Inhibitor–Based Regimens
Panel’s Recommendations for Integrase Strand Transfer Inhibitor–Based Regimens as Initial Therapy
Adverse Effects
Integrase Strand Transfer Inhibitor Use in People of Childbearing Potential
Bictegravir
References
Non-Nucleoside Reverse Transcriptase Inhibitor-Based Regimens
Summary
Doravirine
Rilpivirine
References
Protease Inhibitor-Based Regimens
Summary
Darunavir/Ritonavir (DRV/r)
Darunavir/Cobicistat (DRV/c)
References
Other ARV Regimens
Strategies Supported by Evidence from Clinical Trials
References
Advantages and Disadvantages of ARV Components
ARV Components or Regimens Not Recommended as Initial Therapy
Management of People with HIV and ART Experience
Virologic Failure
Virologic Response Definitions
Antiretroviral Therapy Goals and Presence of Viremia While on Antiretroviral Therapy
Causes of Virologic Failure
Managing Patients With Virologic Failure
Managing Virologic Failure in Different Clinical Scenarios
Summary
Antiretroviral Options for People With HIV and Virologic Failure
Isolated Central Nervous System Virologic Failure and Neurologic Symptoms
References
Poor CD4 Cell Recovery
Poor CD4 Cell Recovery
Persistent Immune Activation and Inflammation
ART as a Strategy to Reduce Inflammation
Other Immune-Based Strategies
Treatments Targeting Traditional Risk Factors and Inflammation
Treatments Targeting Putative Drivers of the Inflammatory State
Monitoring Inflammation
References
Optimising ART in the Setting of Virologic Suppression
Reasons to Consider Regimen Optimization in the Setting of Viral Suppression
General Principles of Regimen Optimization
Specific Regimen Optimization Considerations
Optimization Strategies With Good Supporting Evidence for People Without Known Drug Resistance
Three-Drug Regimens
Two-Drug Regimens
Optimization Strategies for People With Viral Suppression and a History of NRTI and/or NNRTI Resistance
Optimization Strategies for People With Viral Suppression and a History of Complex Underlying Resistance
References
Discontinuation or Interruption of ARV
Unanticipated Interruptions of Oral Antiretroviral Drugs
References
Statin Therapy for People with HIV
Background
Rationale for the Panel’s Recommendations for People with HIV Who Are Ages 40 to 75 Years at Low-to-Intermediate (<20%) 10-Year ASCVD Risk
Acknowledgement
References
Special Populations
Early (Acute and Recent) HIV Infection
Introduction
Diagnosing Acute HIV Infection
Diagnosing Acute HIV Infection in People Taking Pre-Exposure Prophylaxis
Acute HIV Infection in People Taking Long-Acting Cabotegravir for Pre-Exposure Prophylaxis
Treating Early HIV Infection
Antiretroviral Regimens for Early HIV Infection
Treatment Regimens for Early HIV Infection During Pregnancy
Follow-Up After Antiretroviral Therapy Initiation
References
Adolescents and Young Adults with HIV
Introduction
Epidemiology
Heterogeneity of Adolescents and Young Adults with HIV
Unique Characteristics and Considerations for Adolescents and Young Adults with HIV
Optimizing Treatment Effectiveness and Supporting Adherence in Adolescents and Young Adults with HIV
Specific Antiretroviral Therapy Considerations in Adolescents and Young Adults with HIV
Preventive Measures and Supporting Long-Term Health in Adolescents and Young Adults with HIV
Transitioning to Adult HIV Care
References
HIV-2 Infection
Overview
Clinical Course of HIV-2 Infection
Diagnostic and Monitoring Assays for HIV-2 Infection
Treatment of HIV-2 Infection
References
HIV and the Older Person
Introduction
HIV Screening and Diagnosis in the Older Person
Antiretroviral Therapy in the Older Person With HIV
HIV and Immunologic Aging
Morbidity, Mortality, and Non-AIDS Complications Among Older People With HIV
References
Substance Use Disorders and HIV
Background on Substance Use Disorders among People with HIV
Commonly Used Substances and Their Impact on HIV and Antiretroviral Therapy
Medications for Treatment of Substance Use Disorders
References
Transplantation in People With HIV
General Principles When Managing People With HIV Before and After Transplant
Outcomes of Transplant in People With HIV and the Importance of Equitable Access to Transplant
Antiretroviral Therapy Before, During, and After Transplant
Prevention of Infectious Complications Post-Transplant
Recipient Considerations
Donor-Related Considerations
Solid Organ Transplant Considerations From Donors With HIV
References
Transgender People with HIV
Introduction
HIV Care Continuum
Pharmacological Considerations
References
Women with HIV
Sex Difference considerations in Antiretroviral Therapy
Adverse Effects
Weight Gain and Antiretroviral Therapy
Adherence to Antiretroviral Therapy
Antiretroviral Therapy Considerations in Adults and Adolescents With HIV Who Are of Childbearing Potential
Antiretroviral Regimen Considerations for Individuals Who Are Trying to Conceive
Reproductive Options for Couples With Differing HIV Status
Hormonal Contraception
Drug–Drug Interactions
Pregnancy
Postpartum Management
Infant Feeding
HIV and Menopause
References
Considerations for Antiretroviral Use in Patients with Coinfections
Hep B/HIV
Recommendations for People With HBV/HIV
Antiretroviral Drugs With Dual Activities Against HBV and HIV
Recommended Therapy
Alternative Therapy
Important Considerations
HBV Drugs Not Recommended
Changing Antiretroviral Therapy
Screening for HBV Before Initiating NRTI-Sparing or NRTI-Limited Antiretroviral Regimens
References
HCV/HIV
Assessment of HCV/HIV Coinfection
Antiretroviral Therapy in HCV/HIV Coinfection
Concurrent Treatment of HIV and HCV Infections
References
TB/HIV
Managing Latent Tuberculosis Infection in People with HIV
Antiretroviral Therapy for Patients with HIV and Active Tuberculosis
References
Limitations to Treatment Safety & Efficacy
Adherence to the Continuum of Care
Introduction
Linkage to Care
Retention in Care
Adherence to Antiretroviral Therapy
Transitions of Care
Long-Acting Antiretroviral Therapy
Conclusion
References
Adverse Effects of ARV Agents
Common and/or Severe Adverse Effects Associated With Antiretroviral Therapy
Antiretroviral Therapy-Associated Adverse Effects That Can Be Managed With Substitution of Alternative Antiretroviral Agents
References
Cost Considerations and ART
Cost Sharing in the United States
Generic Antiretrovirals and Multi-Tablet Regimens
Costs and Cost-Effectiveness of ARV Regimens for Highly Treatment- Experienced People With Multidrug-Resistant HIV
Laboratory Services
Costs and Cost-Effectiveness of Comprehensive HIV Care
Conclusion
References
Drug-Drug Interactions
Overview
Overview
Mechanisms of Pharmacokinetic Interactions
Role of Therapeutic Drug Monitoring in Managing Drug–Drug Interactions
Mechanisms of Antiretroviral-Associated Drug Interactions
PI Drug interactions
Drug Interactions Between Protease Inhibitors and Other Drugs
NNRTI interactions
Drug Interactions Between Non-Nucleoside Reverse Transcriptase Inhibitors and Other Drugs
NRTI interactions
Drug Interactions Between Nucleoside Reverse Transcriptase Inhibitors and Other Drugs
INSTI interactions
CCR5 Antagonist Drug Interactions
Drug Interactions Between the CCR5 Antagonist Maraviroc and Other Drugs
HIV-1 gp120-Directed Attachment Inhibitors
Drug Interactions Between HIV-1 gp120-Directed Attachment Inhibitors and Other Drugs
Capsid Inhibitor Drug Interactions
Drug Interactions Between the Capsid Inhibitor Lenacapavir and Other Drugs
Interactions between PIs and NNRTIs
Interactions Between Non-Nucleoside Reverse Transcriptase Inhibitors and Protease Inhibitors
Interactions between INSTI & NNRTI or PI
Interactions between Integrase Strand Transfer Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors or Protease Inhibitors
Appendix A: Key to Acronyms
Drug Name Abbreviations
General Terms
Study and Trial Names
Appendix B: Drug Characteristics Table
Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors
Characteristics of Protease Inhibitors
Characteristics of Integrase Strand Transfer Inhibitors
Characteristics of the Capsid Inhibitor
Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency
References
Committee
Financial Disclosure
Pediatric ARVs
Home
What’s New
April 2023
January 31, 2023
Introduction
Maternal HIV Testing and Identification of Perinatal HIV Exposure
HIV Testing in Pregnancy
HIV Testing During Labor in People With Unknown HIV Status
HIV Testing During the Postpartum Period
References
Diagnosis of HIV in Infants and Children
Timing of Diagnostic Testing in Infants With Perinatal HIV Exposure
Virologic Testing at Birth for Newborns at High Risk of Perinatal HIV Transmission
Recommended Virologic Testing Schedules for Infants Who Were Exposed to HIV According to Risk of Perinatal HIV Acquisition
Diagnostic Testing in Children With Perinatal HIV Exposure in Special Situations
Diagnostic Testing in Children With Non-Perinatal HIV Exposure or Children With Perinatal HIV Exposure Aged >24 Months
Virologic Assays to Diagnose HIV in Infants Younger Than 18 Months With Perinatal HIV-1 Exposure
Other Issues
Virologic Assays to Diagnose Group M Non-Subtype B and Group O HIV-1 Infections
Chimeric Antigen Receptor T-Cell and Lentiviral-Based Gene Therapy May Give Rise to False-Positive HIV NAT Results
Virologic Assays to Diagnose HIV-2 Infections
References
Clinical and Laboratory Monitoring of Pediatric HIV Infection
Characteristics and Requirements for In-Person Clinic Visits vs. Telemedicine Visits
Immunologic Monitoring in Children: General Considerations
HIV RNA Monitoring in Children: General Considerations
Methodological Considerations When Interpreting and Comparing HIV RNA Assays
References
What to Start
Regimens Recommended for Initial Therapy of ARV-Naive Children
Criteria Used for Recommendations
Factors to Consider When Selecting an Initial Regimen
Choosing an Initial Antiretroviral Regimen for Children With HIV
Integrase Strand Transfer Inhibitor–Based Regimens
Non-Nucleoside Reverse Transcriptase Inhibitor–Based Regimens
Protease Inhibitor–Based Regimens
Selection of Dual-Nucleoside Reverse Transcriptase Inhibitor Backbone as Part of Initial Combination Therapy
References
Regimens Not Recommended for Use in ARV-Naive Children
Antiretroviral Drugs and Drug Combinations Not Recommended for Initial Therapy in Children
Antiretroviral Drugs and Combinations With Insufficient Data to Recommend for Initial Therapy in Children
References
When to Initiate Therapy in ARV-Naive Children
Overview
Survival and Health Benefits Associated With Early Initiation of Antiretroviral Therapy
Neurodevelopmental Benefits Associated With Early Initiation of Antiretroviral Therapy
Immune Benefits Associated With Early Initiation of Antiretroviral Therapy
Viral Suppression and Viral Reservoirs With Early Initiation of Antiretroviral Therapy
Summary
References
ARV Management of Newborns with Perinatal HIV Exposure or HIV Infection
General Considerations for Antiretroviral Management of Newborns Exposed to HIV or Born With HIV
Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn
Antiretroviral Drug Dosing Recommendations for Newborns
Recommendations for Antiretroviral Drugs in Specific Clinical Situations
Presumptive HIV Therapy
Two-Drug Antiretroviral Prophylaxis
Choosing Between Presumptive HIV Therapy and Two-Drug Antiretroviral Prophylaxis
References
Special Considerations for ART Use in Adolescents with HIV
Background
Timing and Selection of Antiretroviral Therapy
Dosing of Antiretroviral Therapy for Adolescents With HIV
Adherence Concerns in Adolescents
Mental Health and Substance Use Concerns in Adolescents
Sexually Transmitted Infections in Adolescents
Contraception, Pregnancy, and Antiretroviral Therapy
Interactions Between Contraceptives and Antiretroviral Drugs
Pregnant Adolescents With HIV
Special Considerations for Adolescents With HIV Who Are Sexual Minorities
Transitioning Adolescents Into Adult HIV Care Settings
References
Adherence to ART in Children and Adolescents with HIV
Background
Specific Adherence Issues in Children
Adherence Assessment and Monitoring
Strategies to Improve and Support Adherence
Regimen-Related Strategies
Patient/Family-Related Strategies
Health Care Provider–Related Strategies
Approaches for Monitoring Medication Adherence
References
Management of Medication Toxicity or Intolerance
Medication Toxicity or Intolerance
Management
References
Management of Children Receiving ART
Modifying Antiretroviral Regimens in Children with Sustained Virologic Suppression on Antiretroviral Therapy
Examples of Changes in Antiretroviral Regimen Components for Children With Sustained Virologic Suppression
References
ART Interruption in Children with HIV
Unplanned Treatment Interruptions
Structured Treatment Interruptions
Short-Cycle Therapy Strategies
Conclusion
References
Committee
HIV Testing and Prevention
PEP Guidelines
Introduction
This fourth edition of the National PEP guidelines
A note about source viral load
A note about gender identity and history
What’s New (2025)
Glossary
Immediate Management of HIV Exposure
PEP Efficacy: Background and Evidence
Assessing HIV Transmission Risk
U=U
What is the HIV transmission risk/exposure?
Factors Modifying HIV Transmission
What is the HIV status of the source individual?
HIV seroprevalence
What is the HIV status of the exposed individual?
When to prescribe PEP
PEP for Non-Occupational Exposure
PEP recommendations after NON-OCCUPATIONAL exposure
PEP for Occupational Exposure
Clinical Assessment and Follow-up
Information about the exposure
Information about the source person
Information about the exposed person
Information to provide to patients when initiating PEP
Laboratory Assessment and Follow-up
Follow-up of indeterminate HIV test results
Prescribing PEP
What to prescribe
Recommended PEP regimens
Medications and cautions
Adverse Events
Management of Co-Exposures
Sexually transmitted infections (STIs)
Hepatitis B (HBV)
Hepatitis C (HCV)
Tetanus
Additional Clinical Considerations
Pregnancy and breastfeeding
Missed PEP doses
Individuals at risk of HIV acquisition who decline PEP
Individuals at negligible risk of HIV transmission who request PEP
People who re-present for PEP after completion of a PEP course
People who re-present with additional high-risk exposure(s) while taking a PEP course
Individuals who are on PrEP
Table 6: Switching from PrEP to PEP
Renal disease
HBV-positive (HBsAg-positive) individuals
Individuals who have been sexually assaulted
Children
People incarcerated or working in correctional or detention facilities
Individuals who commenced PEP overseas
Aboriginal and Torres Strait Islander individuals
Phone support for clinicians
Information for patients
Appendices
Appendix A: Evidence for three-drug versus two-drug PEP regimens
Appendix B: HIV and body fluids
Appendix C: Cost of PEP regimens
Appendix D: Methods
References
PrEP Guidelines
Introduction
Introduction
The recommendations in these guidelines are designed to
These guidelines are intended for use by
Key recommendations of the ASHM PrEP Guidelines Panel
On-demand† PrEP is contraindicated in people with chronic hepatitis B infection
PrEP safety and efficacy
References
PrEP in Australia
HIV epidemiology
HIV prevention
HIV risk categories and targeted availability of PrEP in Australia
How to access PrEP in Australia
Models of PrEP delivery in clinical practice
References
References
Behavioural suitability for PrEP
Suitability for PrEP
These ASHM 2025 PrEP guidelines recommend daily PrEP for all people at risk of HIV infection
PrEP suitability criteria for men who have sex with men
PrEP suitability criteria for trans and gender diverse people
PrEP suitability criteria for heterosexuals
PrEP suitability criteria for people who inject drugs
Suitability for PrEP – Parallel chapter
References
Clinical assessment before starting PrEP
HIV testing
HIV testing
Symptoms and abnormalities associated with primary or acute HIV infection, overall and by region
Concerns about TD* or FTC resistance
Assessment of renal function at baseline
Assessment and management of sexually transmissible infections at baseline
Assessment of hepatitis A, B and C status
Assessment of bone health
Assessment for pregnancy in women of childbearing age
References
Providing PrEP
Goals of PrEP
HIV testing
Daily PrEP
On-demand PrEP†
Evidence in support of on-demand† PrEP dosing
The efficacy of on-demand† PrEP in people who use it infrequently
Toxicity and on-demand† PrEP
Preference for on-demand† versus daily PrEP
The choice of PrEP schedule: daily versus on-demand PrEP
Summary of when to recommend daily and on-demand†PrEP
Injectable PrEP
Introduction and the Australian Context
Evidence for effectiveness
Safety and Adverse Events
Contraindications to CAB-LA PrEP
References
Other PrEP dosing schedules
Evaluation of the need for ongoing PrEP
Laboratory and clinical follow-up schedule at baseline and follow-up
Indicated medication
What not to use for PrEP
PrEP dosing schedule
PrEP medication side effects
PrEP medication drug interactions
Time to achieving and maintaining protection
PrEP and travel
PEP use and PrEP
Discontinuing daily PrEP in cis men
Discontinuing daily PrEP in cis men
Discontinuing daily PrEP for other populations
Recommencing PrEP
References
Clinical follow-up and monitoring of patients on PrEP
Recommended schedule of testing and follow-up for individuals on PrEP
Laboratory evaluation and clinical follow-up of individuals who are prescribed PrEP
PrEP follow-up procedures
Testing for HIV
A positive HIV test result
Indeterminate HIV test results in the first 3 months on PrEP
A recent high-risk exposure (within 72 hours)
Monitoring of renal function
Testing for STIs
Monitoring HBV Hepatitis B and HCV Hepatitis C virus infections
Hepatitis B virus monitoring
Hepatitis C virus monitoring
Managing side-effects
Optional assessments
References
Special clinical considerations
Aboriginal and Torres Strait Islander people
People ineligible for Medicare including newly-arrived Asian-born men who have sex with men
Transgender women
Transgender men
Women taking PrEP during conception, pregnancy and breastfeeding
Breastfeeding
Patients with chronic renal failure
Patients with chronic active HBV infection
PrEP and Chronic Hepatitis B
Use of on-demand HIV PrEP in people with chronic hepatitis B infection
Circumstances where on-demand TD*/FTC PrEP cannot be used for people living with chronic HBV infection
References
Adolescent minors
The ASHM PrEP Guidelines Panel endorses this approach and encourages clinicians to work with adolescents taking PrEP to design an augmented clinical review schedule
References
PEP and PrEP
HIV non-occupational post-exposure prophylaxis and pre-exposure prophylaxis
References
Improving medication adherence
Improving medication adherence
Behavioral strategies to reduce risk
References
Suitability for PrEP – Parallel of Chapter 4
Suitability for PrEP – Parallel of Chapter 4
PrEP suitability criteria for men who have sex with men
PrEP suitability criteria for heterosexuals
PrEP suitability criteria for people who inject drugs
References
Anal Cancer Screening
Introduction
Overview
All anal cancer screening should include
The recommendations in these guidelines
These guidelines are intended
Methods
Populations to screen
Annual age-standardised anal cancer incidence
Anal cancer incidence per 100000
Age-specific anal cancer incidence
Possible anal cancer screening methods
High risk HPV (HRHPV) testing
Anal Cytology
Performance of screening tools
The IANS guidelines for ASCC screening
Screening Intervals and Cessation
The implementation of any recommendations
Key recommendations
All anal cancer screening should include
As anal cancer screening and HRA capacity
Proposed screening algorithm
Definitions
Management of screening test results
Where HRA services are available
Where HRA services are not available
Frequency and management of HPV screening
Abbreviations
Notes
Anal HSIL treatment
Ablative treatments
Topical treatments
HPV Vaccination
General advice
Useful links & References
Useful Links
References
Appendix
Australian Modified Bethesda System for reporting anal cytology
Acknowledgements
Frequently used tools
Frequently Used Tools
Decision Making In PrEP
Decision Making in HIV PEP
Could It Be HIV? Clinical Indicator Tool
HIV Monitoring Tool
HIV Monitoring Tool for Women
Long-Acting Injectable HIV Treatment Tool
