Ian J Bishop1, Alida M Gertz2, Boikhutso Simon3, Leabaneng Tawe4, Kwana Lechiile4, Serena Liu1, Nicholas Teodoro1, Aamirah Mussa3, Ava Avalos3, Sifelani Malima5, Tshego Maotwe6, Lesego Mokganya5, Carolyn L Westhoff1, Chelsea Morroni7. 1. Columbia University Medical Center, 622 West 168th Street, New York, NY 10032, United States. 2. Botswana-University of Pennsylvania Partnership, University of Botswana Main Campus 244G - Room 103, Gaborone, Botswana; Botswana Harvard Partnership, Private Bag BO 320, Gaborone, Botswana. 3. Botswana Harvard Partnership, Private Bag BO 320, Gaborone, Botswana. 4. Botswana-University of Pennsylvania Partnership, University of Botswana Main Campus 244G - Room 103, Gaborone, Botswana. 5. Botswana Ministry of Health and Wellness, Nelson Mandela Drive, Gaborone, Botswana. 6. Botswana Ministry of Health and Wellness, Nelson Mandela Drive, Gaborone, Botswana; Afya Bora Consortium Fellowship Program, Botswana. 7. Botswana-University of Pennsylvania Partnership, University of Botswana Main Campus 244G - Room 103, Gaborone, Botswana; Botswana Harvard Partnership, Private Bag BO 320, Gaborone, Botswana; Liverpool School of Tropical Medicine, Pembroke Pl, Liverpool L3 5QA, United Kingdom. Electronic address: chelsea.morroni@lstmed.ac.uk.
Abstract
OBJECTIVES: To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART). STUDY DESIGN: We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study among women using single-rod etonogestrel contraceptive implants in Botswana. We compared plasma etonogestrel concentrations, sampled at a single time-point between 3 and 12 months from implant insertion, among implant users living with HIV and receiving dolutegravir-based ART with HIV-negative implant users. We also assessed concentrations among implant users living with HIV and receiving efavirenz-based ART. We compared geometric mean etonogestrel concentrations analyzing data from 142 participants: 97 HIV-negative, 30 using dolutegravir, and 15 using efavirenz. RESULTS: The groups were similar. Duration of implant use was between 3 and 12 months (median = 5). Geometric mean etonogestrel plasma concentrations and 90% confidence intervals of the mean were 227.5(212.4-243.8), 289.6(251.8-333.0) and 76.4(63.9-91.4) pg/mL among the HIV-negative, dolutegravir- and efavirenz-based ART groups, respectively. All women in the HIV-negative and dolutegravir-based ART groups had etonogestrel concentrations above 90 pg/mL; 9/15 women (60%) using efavirenz-based ART had concentrations below 90 pg/mL. On average, etonogestrel levels were lower among individuals who had implants inserted for longer durations. CONCLUSIONS: Implant users receiving dolutegravir-based ART had a higher mean etonogestrel concentration compared to HIV-negative women, and none had etonogestrel concentrations below the posited threshold for ovulation suppression. In contrast, women in the efavirenz-group had much lower etonogestrel concentrations. Overall, these data provide evidence that the etonogestrel implant may be effectively combined with dolutegravir-based ART regimens. IMPLICATIONS: The etonogestrel implant remains a highly effective contraceptive option for women living with HIV who use dolutegravir-based ART.
OBJECTIVES: To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART). STUDY DESIGN: We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study among women using single-rod etonogestrel contraceptive implants in Botswana. We compared plasma etonogestrel concentrations, sampled at a single time-point between 3 and 12 months from implant insertion, among implant users living with HIV and receiving dolutegravir-based ART with HIV-negative implant users. We also assessed concentrations among implant users living with HIV and receiving efavirenz-based ART. We compared geometric mean etonogestrel concentrations analyzing data from 142 participants: 97 HIV-negative, 30 using dolutegravir, and 15 using efavirenz. RESULTS: The groups were similar. Duration of implant use was between 3 and 12 months (median = 5). Geometric mean etonogestrel plasma concentrations and 90% confidence intervals of the mean were 227.5(212.4-243.8), 289.6(251.8-333.0) and 76.4(63.9-91.4) pg/mL among the HIV-negative, dolutegravir- and efavirenz-based ART groups, respectively. All women in the HIV-negative and dolutegravir-based ART groups had etonogestrel concentrations above 90 pg/mL; 9/15 women (60%) using efavirenz-based ART had concentrations below 90 pg/mL. On average, etonogestrel levels were lower among individuals who had implants inserted for longer durations. CONCLUSIONS: Implant users receiving dolutegravir-based ART had a higher mean etonogestrel concentration compared to HIV-negative women, and none had etonogestrel concentrations below the posited threshold for ovulation suppression. In contrast, women in the efavirenz-group had much lower etonogestrel concentrations. Overall, these data provide evidence that the etonogestrel implant may be effectively combined with dolutegravir-based ART regimens. IMPLICATIONS: The etonogestrel implant remains a highly effective contraceptive option for women living with HIV who use dolutegravir-based ART.
Authors: Randy M Stalter; Gustavo Amorim; A Rain Mocello; Beatrice Jakait; Bryan E Shepherd; Beverly Musick; Caitlin Bernard; Elizabeth A Bukusi; Kara Wools-Kaloustian; Craig R Cohen; Constantin T Yiannoutsos; Rena C Patel Journal: J Int AIDS Soc Date: 2022-09 Impact factor: 6.707
Authors: Owain Roberts; Hannah Kinvig; Andrew Owen; Mohammed Lamorde; Marco Siccardi; Kimberly K Scarsi Journal: HIV Med Date: 2021-07-30 Impact factor: 3.094