PT  - JOURNAL ARTICLE
AU  - Lisa Levy
AU  - Jill M. Peterson
AU  - Lauren D. Kudrick
AU  - Bhavna Chohan
AU  - Everline Bosek
AU  - Irene Mukui
AU  - Mary Mugambi
AU  - Sarah Masyuko
AU  - Owen Mugurungi
AU  - Nonhlanhla Ndlovu
AU  - Imelda Mahaka
AU  - Megan Dunbar
AU  - Anita Hettema
AU  - Rudo A.P. Kuwengwa
AU  - Sindy Matse
AU  - Saiqa Mullick
AU  - Letitia Greener
AU  - Cara O'Connor
AU  - Diantha Pillay
AU  - Maria Fawzy
AU  - John W. Mellors
AU  - Urvi M. Parikh
AU  - the Global Evaluation of Microbicide Sensitivity (GEMS) project
TI  - Casting a Wide Net: HIV Drug Resistance Monitoring in Pre-Exposure Prophylaxis Seroconverters in the Global Evaluation of Microbicide Sensitivity Project
AID  - 10.9745/GHSP-D-21-00122
DP  - 2022 Apr 28
TA  - Global Health: Science and Practice
PG  - e2100122
VI  - 10
IP  - 2
4099  - http://www.ghspjournal.org/content/10/2/e2100122.short
4100  - http://www.ghspjournal.org/content/10/2/e2100122.full
SO  - GLOB HEALTH SCI PRACT2022 Apr 28; 10
AB  - Key FindingsMonitoring for HIV drug resistance (HIVDR) within pre-exposure prophylaxis (PrEP) programs is feasible, and samples collected through these methods can be used to provide early indicators of the risk of HIVDR among PrEP users.Additional information beyond clinical trial data is needed on the risk of HIVDR in large-scale PrEP rollout programs, where HIV testing occurs less frequently and adherence support strategies are less robust.Laboratory capacity remains a major obstacle to establishing HIVDR monitoring systems in low- and middle-income countries.Key ImplicationsPolicy makers should consider short-term and long-term HIVDR monitoring needs to best preserve antiretrovirals for use in PrEP and antiretroviral therapy (ART) programs.By coordinating PrEP resistance monitoring with existing HIVDR surveillance, countries may be able to develop a common understanding of overall drug resistance and implications for national PrEP and ART programs.As new PrEP drugs and delivery methods, such as the vaginal ring and the long-acting injectable PrEP become available and as countries transition to alternative first-line ART regimens, more research and surveillance are needed to limit the risk of HIVDR.Background:Evidence of HIV drug resistance (HIVDR) in individuals using oral pre-exposure prophylaxis (PrEP) who acquire HIV is limited to clinical trials and case studies. More data are needed to understand the risk of HIVDR with oral PrEP during PrEP rollout. Mechanisms to collect these data vary, and are dependent on cost, scale of PrEP distribution, and in-country infrastructure for the identification, collection, and testing of samples from PrEP seroconverters.Methods:The Global Evaluation of Microbicide Sensitivity (GEMS) project, in collaboration with country stakeholders, initiated HIVDR monitoring among new HIV seroconverters with prior PrEP use in Eswatini, Kenya, South Africa, and Zimbabwe. Standalone protocols were developed to assess HIVDR among a national sample of PrEP users. In addition, HIVDR testing was incorporated into existing demonstration projects for key populations.Lessons learned:Countries are supportive of conducting a time-limited evaluation of HIVDR during the early stages of PrEP rollout. As PrEP rollout expands, the need for long-term HIVDR monitoring with PrEP will need to be balanced with maintaining national HIV drug resistance surveillance for pretreatment and acquired drug resistance. Laboratory capacity is a common obstacle to setting up a monitoring system.Conclusions:Establishing HIV resistance monitoring within PrEP programs is feasible. Approaches to drug resistance monitoring may evolve as the PrEP programs mature and expand. The methods and implementation support offered by GEMS assisted countries in developing methods to monitor for drug resistance that best fit their PrEP program needs and resources.