HAB HIV Performance Measures: 

ADAP: AIDS Drug Assistance Program 

Performance Measure: ADAP: Inappropriate Antiretroviral 

Regimen Components Resolved by ADAP 

Percent of identified inappropriate antiretroviral (ARV) regimen components prescriptions that are resolved 

by the ADAP program during the measurement year. 

Numerator: 

Number of antiretroviral (ARV) regimen components prescriptions included in the US 

Public Health Service Guidelines, “Antiretroviral Regimens or Components That 

Should Not Be Offered At Any Time”1 and “Antiretroviral Regimens or Components 

That Should Not Be Offered for Treatment of Human Immunodeficiency Virus (HIV) 

Infection in Children”2 that are resolved by the ADAP program during the 

measurement year. 

Denominator: 

Number of inappropriate antiretroviral (ARV) regimen components prescriptions 

included in the US Public Health Service Guidelines, “Antiretroviral Regimens or 

Components That Should Not Be Offered At Any Time”1 and “Antiretroviral 

Regimens or Components That Should Not Be Offered for Treatment of Human 

Immunodeficiency Virus (HIV) Infection in Children” 2 that are identified by ADAP. 

Patient 

Exclusions: 

1. For ADAP clients with multiple sources of funding for their medications, the 

ADAP program is responsible for identifying only ARV regimen components 

funded by ADAP. 

Data Element: 

1. Was the prescribed antiretroviral (ARV) regimen components included in the US 

Public Health Service Guidelines, “Antiretroviral Regimens or Components That 

Should Not Be Offered At Any Time”1 and “Antiretroviral Regimens or 

Components That Should Not Be Offered for Treatment of Human 

Immunodeficiency Virus (HIV) Infection in Children” 2 identified by the ADAP 

program during the measurement year? (Y/N) 

a. If yes, specify the components, the prescribing clinician and client. 

b. In response to the ADAP program contacting the prescribing clinician, was the 

ARV regimen components prescription subsequently modified by the 

prescribing clinician to an ARV regimen components that is not included the US 

Public Health Service Guidelines, “Antiretroviral Regimens or Components 

That Should Not Be Offered At Any Time”1 and “Antiretroviral Regimens or 

Components That Should Not Be Offered for Treatment of Human 

Immunodeficiency Virus (HIV) Infection in Children”2 or was the ARV 

regimen components clinically justified by the prescribing clinician? (Y/N) 

Data Sources:  ADAP data systems 

National Goals, 

Targets, or 

Benchmarks for 

Comparison: 

None available at this time. 

ADAP Final |December 10, 2009 | Page 7 of 9 
HAB HIV Performance Measures: 

ADAP: AIDS Drug Assistance Program 

Performance Measure: ADAP: Inappropriate Antiretroviral 

Regimen Components Resolved by ADAP 

Basis for Selection and Placement: 

The US Public Health Service Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and 

Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection specify antiretroviral 

regimens or components are not generally recommended because of suboptimal antiviral potency, unacceptable 

toxicities, or pharmacologic concerns.1, 2 ADAP programs are included as core medical services funded by the Ryan 

White HIV/AIDS Program, and are therefore, required to provide care and treatment consistent with PHS guidelines. 

US Public Health Service Guidelines: 

Adult and Adolescents Patients: Antiretroviral Regimens or Components That Should 

Not Be Offered At Any Time1 

Components not recommended Exceptions 

Atazanavir + indinavir (AIII) • No exception 

Didanosine + stavudine (AIII) • When no other antiretroviral options are available 

and potential benefits outweigh the risks (BIII) 

2-NNRTI combination (AII) • No exception 

Efavirenz in first trimester of pregnancy or in women with 

significant child-bearing potential (AIII) 

• When no other antiretroviral options are available 

and potential benefits outweigh the risks (BIII) 

Emtricitabine + lamivudine (AIII) • No exception 

Etravirine + Unboosted PI (AII) • No exception 

Etravirine + ritonavir-boosted atazanavir or fosamprenavir (AII) • No exception 

Etravirine + ritonavir-boosted tipranavir (AII) • No exception 

Nevirapine in treament-naïve women with CD4 >250 or men 

with CD4 >400 (BI) 

• If no other antiretroviral option available; if used 

patients should be closely monitored 

Stavudine + zidovudine (AII) • No exception 

Unboosted darunavir, saquinavir, or tipranavir (AII) • No exception 

Pediatric Patients: Antiretroviral Components Not Recommended as Part of an Antiretroviral Regimen2 

Components not recommended Exceptions 

Atazanavir + indinavir • No exception 

Dual NRTI combinations: 

• Lamivudine + Emtricitabine 

• Stavudine + Zidovudine 

• Stavudine + Didanosine 

• No exception 

• No exception 

• May be considered for use in antiretroviralexperienced children who require therapy change 

Efavirenz in first trimester of pregnancy or sexually active 

adolescent girls of childbearing potential. 

• When no other antiretroviral options are available 

and potential benefits outweigh risks 

Nevirapine initiation in adolescent girls with CD4 >250 

cells/mm3

 or adolescent boys with CD4 >400 cells/mm3 

• Only if benefit clearly outweighs the risk 

Unboosted saquinavir • No exceptions 

ADAP Final |December 10, 2009 | Page 8 of 9 
HAB HIV Performance Measures: 

ADAP: AIDS Drug Assistance Program 

Performance Measure: ADAP: Inappropriate Antiretroviral 

Regimen Components Resolved by ADAP 

References/Notes: 

1 Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral 

agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. December 1, 

2009; 1-161.. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 

December 7, 2009. 

2 Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the 

Use of Antiretroviral Agents in Pediatric HIV Infection. February 23, 2009; pp 47. Available at 

http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf. Accessed September 9, 2009. 

ADAP Final |December 10, 2009 | Page 9 of 9