Objective
We sought to assess the effects of long-term use and safety of the levonorgestrel-releasing (LNG)-intrauterine system (IUS) among human immunodeficiency virus (HIV)-infected women in comparison with HIV-infected women not using the device.
Study Design
Fifteen women using the LNG-IUS and their 25 age- and CD4 + lymphocyte count–matched control subjects with annual follow-up data were followed up for 5 years.
Results
No unplanned pregnancies or pelvic infections occurred among the LNG-IUS users. Altogether, 12 (80%) of the LNG-IUS users continued its use up to 5 years. Annual CD4 + lymphocyte counts were similar in the LNG-IUS users and control subjects throughout the follow-up period. The hemoglobin levels increased initially ( P < .005) and remained higher among the LNG-IUS users ( P < .02). Pap smears displayed non-squamous intraepithelial lesion cytology in ≥85% of cases in both groups.
Conclusion
No unfavorable effects on the course of HIV infection were noted during long-term use of the LNG-IUS. Dual protection by means of an LNG-IUS and condoms might be an ideal contraceptive strategy for HIV-infected women.
With an estimated >130 million users, intrauterine contraception is one of the most widely used methods of contraception worldwide. The countries with the highest prevalence of intrauterine device (IUD) use, exceeding 40% among married or cohabiting women, are China, the Democratic People’s Republic of Korea, and Kazakhstan. Women in sub-Saharan Africa show the lowest prevalence (0.5%) of IUD use globally.
Infection with the human immunodeficiency virus (HIV) is a disease of reproductive-aged women. Yet surprisingly little has been published on the topic of contraception and HIV infection. Research data concerning the use of intrauterine contraception in HIV-infected women are even more scarce. However, the safety of IUDs in HIV-infected women has been recently recognized, and their use in women living with HIV/AIDS has recently been classified as category 2 (“using the method generally outweighs the theoretical or proven risks”) by the World Health Organization.
We have previously assessed use of the levonorgestrel-releasing (LNG)-intrauterine system (IUS) in HIV-infected women in an extended case report as well as in a prospective 1-year follow-up study. In these studies use of the LNG-IUS was found to be safe, with effects similar to those seen in women not infected with HIV.
The use of hormonal contraception has been considered to be safe among HIV-infected women. However, in a recent randomized study in which the safety of contraception in HIV-infected women not receiving antiretroviral (ARV) medication was assessed, it was reported, strikingly, that progression of HIV infection was more rapid among women randomized to hormonal contraception in comparison with those using an IUD.
The purpose of the present study was to assess the effects of long-term use and the safety of the LNG-IUS among HIV-infected women in comparison with HIV-infected women not using the device.
Materials and Methods
Prior to initiation, the study was approved by the institutional review board of the Helsinki University Central Hospital. The study subjects and their controls were identified retrospectively among women attending a gynecological outpatient clinic for HIV-infected women living in the Helsinki metropolitan area. The total patient population at the clinic is approximately 300 women. Gynecologic follow-up and Pap smear screening is organized at 6- to 12-month intervals at the department of obstetrics and gynecology, whereas treatment of HIV infection takes place at 3- to 6-month intervals at the department of infectious diseases.
For each subject using the LNG-IUS, 1 or 2 control subjects were identified. The subjects using the LNG-IUS had had at least 5 years of follow-up since insertion of the device, and the control subjects had had at least 5 years of follow-up. The LNG-IUSes (Mirena, Bayer-Schering Pharma AG, Turku, Finland) were inserted from April 2000 through January 2004. Seven of the women using the LNG-IUS also participated in a previously published prospective study assessing the safety of the device over 1 year. Of the subjects in the LNG-IUS group 13 (87%) were at risk of pregnancy during the follow-up time. Three of them (20%) used the LNG-IUS mainly for the treatment of heavy menstrual bleeding.
For each subject using the LNG-IUS, 1 or 2 control subjects were identified. The subjects and controls were matched for year of birth (±2 years) and CD4 + lymphocyte count (±0.1 × 10 9 /L) at the beginning of follow-up ( Table ). In the control group 1 subject used contraceptive implant and 1 had undergone tubal sterilization. All women were systematically encouraged to use a condom during all intercourse.
