A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa
Abstract Introduction The ongoing rollout of oral tenofovir‐based pre‐exposure prophylaxis (PrEP) has the potential to reduce HIV‐1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV‐1 on PrEP could threaten the treatment effectiveness of overlapping antiretrovirals (tenofovir...
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2025-08-01
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| author | Urvi M. Parikh Lauren D. Kudrick Lisa Levy Everline Bosek Bhavna H. Chohan Irene Mukui Sarah Masyuko Nonhlanhla Ndlovu Imelda Mahaka Owen Mugurungi Gertrude Ncube Anita Hettema Sindy N. Matse Saiqa Mullick Carole L. Wallis Amy L. Heaps Kerri J. Penrose Kevin D. McCormick Lubbe Wiesner Peter L. Anderson Jill M. Peterson Connie Celum Barbra A. Richardson Delivette Castor Shannon Allen Kristine Torjesen John W. Mellors Global Evaluation of Microbicide Sensitivity (GEMS) Project |
| author_facet | Urvi M. Parikh Lauren D. Kudrick Lisa Levy Everline Bosek Bhavna H. Chohan Irene Mukui Sarah Masyuko Nonhlanhla Ndlovu Imelda Mahaka Owen Mugurungi Gertrude Ncube Anita Hettema Sindy N. Matse Saiqa Mullick Carole L. Wallis Amy L. Heaps Kerri J. Penrose Kevin D. McCormick Lubbe Wiesner Peter L. Anderson Jill M. Peterson Connie Celum Barbra A. Richardson Delivette Castor Shannon Allen Kristine Torjesen John W. Mellors Global Evaluation of Microbicide Sensitivity (GEMS) Project |
| author_sort | Urvi M. Parikh |
| collection | DOAJ |
| description | Abstract Introduction The ongoing rollout of oral tenofovir‐based pre‐exposure prophylaxis (PrEP) has the potential to reduce HIV‐1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV‐1 on PrEP could threaten the treatment effectiveness of overlapping antiretrovirals (tenofovir/emtricitabine), contribute to development of resistance, and undermine HIV control efforts. Accordingly, the Global Evaluation of Microbicide Sensitivity (GEMS) project was established to monitor HIVDR in PrEP rollout programmes in Southern and Eastern Africa. Methods GEMS monitored resistance in >100,000 estimated persons who accessed PrEP through national programmes or implementation projects in Southern/Eastern Africa. Participants self‐reported demographics and PrEP adherence. HIV‐1 RNA and tenofovir‐diphosphate levels were measured in blood samples collected at the time of study enrolment from consenting participants diagnosed with HIV who had received PrEP. HIVDR mutations were detected by population genotyping. Results Of 283 reported seroconversions on PrEP from December 2017 through September 2023, 255 (90%) individuals enrolled in GEMS, of which 81 (32%) were from Kenya, 77 (30%) from South Africa, 69 (27%) from Zimbabwe and 28 (11%) from Eswatini. Half (130; 51%) were 15–24 years of age at seroconversion, and three‐quarters (193; 76%) were female. Thirty‐four seroconversions occurred within 30 days of PrEP initiation. Tenofovir‐diphosphate levels were consistent with moderate to high levels (≥350 femtomoles per punch) in 53% (120 of 226) individuals with drug‐level data. Of 154 samples successfully genotyped, 34 (22%; 95% CI [16%, 30%]) had PrEP‐associated mutations; these included 27 samples with M184I/V, one sample with K65KR, and six samples with both K65R and M184I/V. Conclusions The frequency of HIVDR mutations associated with tenofovir or emtricitabine among individuals diagnosed with HIV who had received PrEP (22%) exceeded background levels of transmitted nucleoside reverse transcriptase inhibitor resistance in Southern and Eastern Africa (≤5%) but people with PrEP‐associated mutations are likely to achieve virologic suppression with current first‐line antiretroviral therapy (ART). Improved screening for acute infection before initiating PrEP, surveillance of HIVDR with the introduction of new PrEP programmes and the monitoring of longer‐term ART outcomes in individuals who acquire HIV‐1 on PrEP will be essential to preserve antiretroviral options for both treatment and prevention. |
| format | Article |
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| institution | Kabale University |
| issn | 1758-2652 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
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| series | Journal of the International AIDS Society |
| spelling | doaj-art-445db4e827a042d799d3e912aae3a6d52025-08-25T18:26:38ZengWileyJournal of the International AIDS Society1758-26522025-08-01288n/an/a10.1002/jia2.70011A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South AfricaUrvi M. Parikh0Lauren D. Kudrick1Lisa Levy2Everline Bosek3Bhavna H. Chohan4Irene Mukui5Sarah Masyuko6Nonhlanhla Ndlovu7Imelda Mahaka8Owen Mugurungi9Gertrude Ncube10Anita Hettema11Sindy N. Matse12Saiqa Mullick13Carole L. Wallis14Amy L. Heaps15Kerri J. Penrose16Kevin D. McCormick17Lubbe Wiesner18Peter L. Anderson19Jill M. Peterson20Connie Celum21Barbra A. Richardson22Delivette Castor23Shannon Allen24Kristine Torjesen25John W. Mellors26Global Evaluation of Microbicide Sensitivity (GEMS) ProjectUniversity of Pittsburgh Pittsburgh Pennsylvania USAUniversity of Pittsburgh Pittsburgh Pennsylvania USAFHI 360 Durham North Carolina USAUniversity of Washington‐Kenya Nairobi KenyaKenya Medical Research Institute (KEMRI) Nairobi KenyaNational AIDS and STI Programme Ministry of Health Nairobi KenyaNational AIDS and STI Programme Ministry of Health Nairobi KenyaPangaea Zimbabwe Harare ZimbabwePangaea Zimbabwe Harare ZimbabweMinistry of Health and Child Care Harare ZimbabweMinistry of Health and Child Care Harare ZimbabweClinton Health Access Initiative Mbabane EswatiniMinistry of Health Mbabane EswatiniWits RHI The University of the Witwatersrand Johannesburg South AfricaBARC‐SA and Lancet Laboratories Johannesburg South AfricaUniversity of Pittsburgh Pittsburgh Pennsylvania USAUniversity of Pittsburgh Pittsburgh Pennsylvania USAUniversity of Pittsburgh Pittsburgh Pennsylvania USADivision of Clinical Pharmacology Department of Medicine University of Cape Town Cape Town South AfricaUniversity of Colorado‐Anschutz Medical Campus Aurora Colorado USAFHI 360 Durham North Carolina USADepartments of Global Health Medicine, Epidemiology and Biostatistics University of Washington Seattle Washington USADepartments of Global Health Medicine, Epidemiology and Biostatistics University of Washington Seattle Washington USAColumbia University Irving Medical Center New York New York USAUnited States Agency for International Development (USAID) Washington DC USAFHI 360 Durham North Carolina USAUniversity of Pittsburgh Pittsburgh Pennsylvania USAAbstract Introduction The ongoing rollout of oral tenofovir‐based pre‐exposure prophylaxis (PrEP) has the potential to reduce HIV‐1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV‐1 on PrEP could threaten the treatment effectiveness of overlapping antiretrovirals (tenofovir/emtricitabine), contribute to development of resistance, and undermine HIV control efforts. Accordingly, the Global Evaluation of Microbicide Sensitivity (GEMS) project was established to monitor HIVDR in PrEP rollout programmes in Southern and Eastern Africa. Methods GEMS monitored resistance in >100,000 estimated persons who accessed PrEP through national programmes or implementation projects in Southern/Eastern Africa. Participants self‐reported demographics and PrEP adherence. HIV‐1 RNA and tenofovir‐diphosphate levels were measured in blood samples collected at the time of study enrolment from consenting participants diagnosed with HIV who had received PrEP. HIVDR mutations were detected by population genotyping. Results Of 283 reported seroconversions on PrEP from December 2017 through September 2023, 255 (90%) individuals enrolled in GEMS, of which 81 (32%) were from Kenya, 77 (30%) from South Africa, 69 (27%) from Zimbabwe and 28 (11%) from Eswatini. Half (130; 51%) were 15–24 years of age at seroconversion, and three‐quarters (193; 76%) were female. Thirty‐four seroconversions occurred within 30 days of PrEP initiation. Tenofovir‐diphosphate levels were consistent with moderate to high levels (≥350 femtomoles per punch) in 53% (120 of 226) individuals with drug‐level data. Of 154 samples successfully genotyped, 34 (22%; 95% CI [16%, 30%]) had PrEP‐associated mutations; these included 27 samples with M184I/V, one sample with K65KR, and six samples with both K65R and M184I/V. Conclusions The frequency of HIVDR mutations associated with tenofovir or emtricitabine among individuals diagnosed with HIV who had received PrEP (22%) exceeded background levels of transmitted nucleoside reverse transcriptase inhibitor resistance in Southern and Eastern Africa (≤5%) but people with PrEP‐associated mutations are likely to achieve virologic suppression with current first‐line antiretroviral therapy (ART). Improved screening for acute infection before initiating PrEP, surveillance of HIVDR with the introduction of new PrEP programmes and the monitoring of longer‐term ART outcomes in individuals who acquire HIV‐1 on PrEP will be essential to preserve antiretroviral options for both treatment and prevention.https://doi.org/10.1002/jia2.70011HIVHIV preventionpre‐exposure prophylaxisdrug resistancetenofovir disoproxil fumarate/emtricitabinesub‐Saharan Africa |
| spellingShingle | Urvi M. Parikh Lauren D. Kudrick Lisa Levy Everline Bosek Bhavna H. Chohan Irene Mukui Sarah Masyuko Nonhlanhla Ndlovu Imelda Mahaka Owen Mugurungi Gertrude Ncube Anita Hettema Sindy N. Matse Saiqa Mullick Carole L. Wallis Amy L. Heaps Kerri J. Penrose Kevin D. McCormick Lubbe Wiesner Peter L. Anderson Jill M. Peterson Connie Celum Barbra A. Richardson Delivette Castor Shannon Allen Kristine Torjesen John W. Mellors Global Evaluation of Microbicide Sensitivity (GEMS) Project A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa Journal of the International AIDS Society HIV HIV prevention pre‐exposure prophylaxis drug resistance tenofovir disoproxil fumarate/emtricitabine sub‐Saharan Africa |
| title | A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa |
| title_full | A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa |
| title_fullStr | A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa |
| title_full_unstemmed | A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa |
| title_short | A cross‐sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV‐1 in tenofovir disoproxil fumarate‐based pre‐exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa |
| title_sort | cross sectional study evaluating the frequency of hiv drug resistance mutations among individuals diagnosed with hiv 1 in tenofovir disoproxil fumarate based pre exposure prophylaxis rollout programmes in kenya zimbabwe eswatini and south africa |
| topic | HIV HIV prevention pre‐exposure prophylaxis drug resistance tenofovir disoproxil fumarate/emtricitabine sub‐Saharan Africa |
| url | https://doi.org/10.1002/jia2.70011 |
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