NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) Mechanism of Action

A. Mechanism of Action A well-characterized mechanism of action for a new antiretroviral drug can provide insight into the regions of the HIV genome where mutations that confer resistance may develop. These regions are not limited to the site of action (viral-encoded target) of the investigational drug and can include the enzyme substrate(s) (e.g., Gag and Gag-Pol cleavage sites for protease inhibitors) or another viral-encoded protein(s) existing in a quaternary complex with the target protein (e.g., gp120 and gp41). Any metabolite that exerts inhibitory activity should be delineated and its specificity for the target shown. For example, reverse transcriptase (RT) inhibitors should show selectivity for RT over cellular DNA and RNA polymerases.


IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY


Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

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Last updated : 10-Oct-2010