GEMS – December 2017

GEMS informs policies and defines programmatic considerations related to use of ARV-based HIV prevention products and risk of resistance.

• Genital swabs testing begins and assay development is underway.
• Drug resistance testing in Kenya progresses.
• Drug resistance testing in South Africa planned.
• Collaboration in Zimbabwe begins.
• GEMS to offer technical assistance on drug resistance testing.
• Oral PrEP modeling progresses.

Genital swabs testing begins and assay development is underway. In collaboration with Partners PrEP and the Microbicide Trials Network (MTN), the GEMS laboratory team is continuing to test vaginal swabs from seroconverters to determine if drug resistance occurred in the genital tract (rather than the plasma) of women who seroconverted on active TDF/FTC product. The lab team is continuing to optimize next-generation sequencing protocols for dried blood spots.

Drug resistance testing in Kenya progresses. The national seroconverter protocol to collect a blood specimen on PrEP seroconverters is under review with NASCOP, prior to submission for ethics approval. It is concurrently undergoing an internal review by KEMRI investigators. In the meantime, GEMS has established a specimen collection and testing mechanism with POWER and Partners Scale-Up projects.

Drug resistance testing in South Africa planned. The GEMS team has been coordinating with the Anova Health Institute to monitor for HIV drug resistance as part of the national rollout at select Anova sites. GEMS and Anova drafted a drug resistance monitoring protocol that was submitted for expedited ethics review.

Collaboration in Zimbabwe begins. GEMS held follow-up in-country meetings with the MOHCC, PSI, and other PrEP projects in October 2017, to plan next steps for drug resistance monitoring. This team of implementing partners drafted a protocol, led by MOHCC, to collect a blood specimen on PrEP seroconverters.

GEMS to offer technical assistance on drug resistance testing. Toolkit materials to support drug resistance testing in countries have been developed and reviewed by various stakeholders. These materials and GEMS support will be offered to countries interested in establishing a drug resistance monitoring plan. Ongoing conversations about this technical assistance have occurred with the WHO and partners in Lesotho, Namibia, and Tanzania.

Oral PrEP modeling progresses. Modelers continue to review and interpret results on the impact of drug resistance on PrEP and ART with modeling experts and stakeholders in South Africa.