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Longer sustained use of levonorgestrel IUD than copper IUD by women with HIV / "Randomized controlled trial of intrauterine device safety in women living with HIV"
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Conference on Retroviruses and Opportunistic Infections (CROI), March 4-7, 2019, Seattle
Mark Mascolini
HIV-positive women in a South African randomized trial proved more likely to continue using a levonorgestrel intrauterine device (LNG-IUD) than a copper IUD (C-IUD), mainly because they endured less IUD-related pain and bleeding with the LNG-IUD [1]. Because genital HIV shedding and pregnancy incidence were similar with the two devices, the researchers propose that the LNG-IUD "would be a valuable addition to the contraceptive method mix for women living with HIV."
Researchers from fhi360 and collaborators at other centers noted that women with HIV use contraceptive methods less often than other women and have more mistimed pregnancies. Although long-acting reversible contraceptive methods are available and cost-effective in regions with high HIV prevalence, the investigators note, provider and peer perceptions may keep women with HIV from using IUDs.
Both LNG-IUDs and C-IUDs are highly effective, the investigators observe, and LNG-IUDs can be therapeutic in women with dysfunctional uterine bleeding. A large trial in postpartum HIV-positive Ugandan women found high acceptability of both IUDs but did not assess HIV disease measures [2].
The new trial, 2IUDnCT, aimed to compare LNG-IUDs and C-IUDs in women with HIV by evaluating genital HIV shedding (a surrogate for HIV transmission), HIV progression, and IUD acceptability. The double-blind trial recruited nonpregnant women with HIV in Cape Town, South Africa. Women taking antiretroviral therapy (ART) had to have a viral load below 1000 copies in the last 6 months, while ART-naive women had to have a CD4 count above the ART-initiation level by 2014-2017 South African guidelines. The primary outcome was detectable genital viral load at month 6 after adjustment for baseline genital viral load.
2IUDnCT randomized 98 women to C-IUD and 101 to LNG-IUD. Age averaged 31.4 in both groups, number of prior pregnancies averaged 2, and about 85% of women had only 1 sex partner in the last 12 months. Proportions of C-IUD and LNG-IUD women with a reproductive tract infection at screening were 30.6% and 39.6%. Respective proportions with a genital viral load above 40 copies at screening were 30% and 28%. Median plasma HIV loads were 3.5 and 3.6 log10 copies (about 3000 to 4000 copies).
As-treated and intention-to-treat analyses saw no significant differences between study arms in proportion with a detectable genital viral load at 6 months or at the end of the study. No genital viral load differences between arms emerged in analyses restricted to women using ART or women not yet using ART. Nor did the IUD arms differ in proportions with a detectable plasma load at 6 months or the end of the study in ART-using women. Change in plasma load did not differ by treatment arm among ART-naive women.
Three quarters of women (76%) continued using their IUD for 24 months. Both IUD expulsion and stopping for all causes were higher among women using the C-IUD. Statistical analysis determined that elective discontinuation was almost 9-fold higher among C-IUD users (hazard ratio 8.75, 95% confidence interval 3.08 to 24.8). ART use status had no impact on IUD discontinuation trends.
Serious adverse event rates were low and similar to those recorded for marketed C-IUDs and LNG-IUDs: pregnancy with IUD in place, 1 C-IUD and 1 LNG-IUD; tubal ectopic pregnancy with IUD in place, 2 C-IUD and 0 LNG-IUD; pelvic inflammatory disease, 1 C-IUD and 2 LNG-IUD.
The researchers conclude that C-IUDs and LNG-IUDs "are similarly safe relative to HIV disease transmission and progression and with respect to pelvic inflammatory disease and pregnancy incidence." They believe their findings indicate that LNG-IUDs would be a useful option for women with HIV and note that one bioidentical to the marketed Mirena LNG-IUD is being introduced in developing countries.
References
1. Todd CS, Jones J, Langwenya N, Hoover DR, Petro G, Myer L. Randomized controlled trial of intrauterine device safety in women living with HIV. Conference on Retroviruses and relative to HIV disease transmission and progression and with respect to PID and pregnancy incidence Opportunistic Infections (CROI). March 4-7, 2019. Seattle. Abstract 50.
2. Kakaire O, Byamugisha JK, Tumwesigye NM, Gemzell-Danielsson K. Intrauterine contraception among women living with human immunodeficiency virus: a randomized controlled trial. Obstet Gynecol. 2015;126:928-934.
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