Developing and Testing a Griffithsin (non-ARV) Microbicide

The Population Council is developing a griffithsin-containing microbicide to prevent the transmission of HIV and other sexually transmitted infections.

The Issue

The Population Council has been a leader in research on and development of microbicides since the 1990s. Today, we are developing user-controlled prevention methods that protects against HIV and other sexually transmitted infections (STIs) that can increase susceptibility to HIV.

Current HIV prevention methods include abstinence, condoms, and pre- and post-exposure prophylaxis with antiretrovirals (ARVs) like Truvada®, which are also used to treat HIV.

There is some concern that the use of ARV-based products for HIV prevention could foster the development or spread of drug-resistant strains of the virus that would compromise subsequent ARV treatment.

Use of ARVs for HIV prevention requires HIV screening before and during use, which may pose a barrier to access in low-resource/high-demand settings. A non-ARV microbicide could eliminate the need for HIV screening, help to reduce the emergence of drug-resistant HIV types, and potentially be provided over-the-counter.

The Progress

In 2013, the Council was awarded a cooperative agreement from PEPFAR, and administered by USAID, to investigate griffithsin (GRFT) as a vaginal microbicide. GRFT is a naturally occurring protein isolated from algae that has potent activity against HIV and other STIs. GRFT for drug development is produced in tobacco plants, and initial pre-clinical testing has shown it to be safe and non-irritating in vitro (in cells and tissue) and in vivo (in animals).

Results from the first in-human clinical trial of griffithsin and carrageenan in a gel formulation found it to be safe for vaginal use for up to 14 days with potent anti-HIV activity in cell-based assays and cervical explants up to 8 hours after receiving the dose.  Results from these studies are informing the development of other delivery systems for GRFT, including fast-dissolving inserts and intravaginal rings to provide on-demand and sustained protection. Additional delivery systems may be developed in the future. 

The Impact

Data from PATH and the Population Council suggest the potential of formulating griffithsin as a fast dissolving insert that a woman could administer at the time of sex to prevent three incurable sexually transmitted infections: HIV, herpes simplex virus (HSV-2) and human papilloma virus (HPV). Multipurpose products that prevent sexually transmitted infections, including HIV, would make vital contributions to global public health.

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