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The development of rectal microbicides for HIV prevention
1University of Pittsburgh, Department of Medicine , Pittsburgh , USA imcgowan@pitt.edu.
Expert Opinion on Drug Delivery
|November 26, 2013
Summary
Rectal microbicides show promise for HIV prevention, particularly for men who have sex with men at high risk. Research is advancing, with tenofovir gel poised for further testing in effectiveness trials.
Area of Science:
- HIV Prevention Research
- Rectal Microbicide Development
- Pharmacokinetics/Pharmacodynamics
Background:
- High HIV infection rates persist among men who have sex with men globally.
- Unprotected receptive anal intercourse poses a significant HIV risk.
- Advances include oral pre-exposure prophylaxis, vaginal microbicides, and treatment as prevention.
Purpose of the Study:
- To review the current state of rectal microbicide research.
- To identify challenges and future directions in rectal microbicide development.
- To inform decisions on advancing rectal microbicides into later-stage trials.
Main Methods:
- Review of completed and ongoing Phase I rectal microbicide studies.
- Emphasis on pharmacokinetic/pharmacodynamic data generation.
- Analysis of study designs for informed decision-making.
Main Results:
- Preclinical data support the feasibility of rectal microbicides.
- Significant community interest exists for rectal microbicide development.
- Phase II study (MTN-017) of tenofovir 1% gel is a key step.
Conclusions:
- Strong rationale exists for developing rectal microbicides for HIV prevention.
- Sustained safety, acceptability, and adherence are crucial for success.
- Successful Phase II trials may lead to Phase III effectiveness testing.
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