He said through the Pre-approval Access for HIV/AIDS Therapies (PaATH) mechanism, the government of Guyana would grant provisional approval to pediatric HIV medicines approved by the U.S. Food and Drug Administration within the U.S. Department of Health and Human Services.
â€œThese antiretroviral drugs will then be available for purchase and use in Guyana while they await full approval through the government of Guyana's drug approval process, Goosby said in a statement.
He said variations from country to country in the drug registration process also result in delays to access, adding that access to pediatric antiretroviral treatment is further complicated by the fact that there are fewer formulations of antiretroviral drugs for children than there are for adults.
In Guyana, an estimated 18,000 people are living with HIV, and about six percent of these HIV infections are in children, Goosby said.
â€œRecognizing the impact of HIV/AIDS in Guyana, the government of Guyana has embraced the PaATH to further their country's fight against the virus, he said, stating that Guyana has â€œlong been regarded as an innovator and global leader addressing regulatory issues specific to the developing world, particularly in the area of HIV/AIDS.
Goosby said Guyana's experience with the PaATH would provide â€œbest practices and lessons learned for other PEPFAR countries interested in expediting their drug approval process. Based on the success in Guyana, he said the project would expand to other PEPFAR-supported countries.