Considerations and challenges in developing novel long-acting antiretrovirals modalities for treatment and prevention of HIV-1 infection: a regulatory perspective.

Autor:	Sampson MR; Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Office of Translational Sciences Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Troy SB, Belew Y, Arya V, Struble KA
Jazyk:	angličtina
Zdroj:	Current opinion in HIV and AIDS [Curr Opin HIV AIDS] 2020 Jan; Vol. 15 (1), pp. 61-65.
DOI:	10.1097/COH.0000000000000587
Abstrakt:	Purpose of Review: Outline some regulatory considerations and scientific challenges related to the development of long-acting antiretrovirals (ARVs) for the treatment and prevention of HIV-1 infection. Recent Findings: Poor adherence to oral ARV regimens continues to pose challenges for effective treatment and prevention of HIV-1 infection. The development of long-acting ARV modalities for treatment and prevention of HIV-1 infection is emerging as a promising alternative to the current treatment and prevention paradigm and has gained considerable interest. Summary: The development of long-acting ARVs can present some unique drug development challenges. Advance planning and prioritization of studies early in development can facilitate the development of long-acting ARVs for the prevention and treatment of HIV-1 infection for all populations, including pediatric patients and pregnant women.
Databáze:	MEDLINE
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