British HIV Association, BASHH and FSRH Guidelines for the Management of the Sexual and Reproductive Health of People Living With HIV Infection 2008

A. Fakoya; H. Lamba; N. Mackie; R. Nandwani; A. Brown; E.J. Bernard; C. Gilling-Smith; C. Lacey; L. Sherr; P. Claydon; S. Wallage; B. Gazzard

Disclosures

HIV Medicine. 2008;9(9):681-720. 

In This Article

5.0 Sexual and Reproductive Health Issues for Women

5.1 BHIVA Guidelines for the Management of HIV Infection in Pregnant Women and the Prevention of Mother-to-child Transmission of HIV

Throughout these guidelines, extensive reference has been made to the management of HIV in pregnancy for which guidelines exist. These are available on the BHIVA website (www.bhiva.org), are updated regularly and should be consulted as appropriate.[10]

5.1.1 Contraception for Women with HIV

5.1.1.1 Introduction. As the health of women and men living with HIV continues to improve with the use of ART, changes in decision-making around sexuality and reproduction may result. Women with HIV infection, like other women, may wish to plan pregnancies, to limit their families, or to avoid pregnancy altogether and therefore require advice on and access to a range of contraceptive methods.

Evidence-based guidelines on contraception management in HIV-positive women do not yet exist and therefore decisions regarding contraception choice must be practical, pragmatic and acceptable to each woman. These contraception guidelines aim to be used as an adjunct to existing FSRH documents, which provide evidence-based guidance on a variety of contraceptive methods (www.ffprhc.org.uk). In addition, the Clinical Effectiveness Unit of the FSRH has produced the UK Medical Eligibility Criteria (UKMEC) for contraceptive use (www.ffprhc.org.uk/admin/uploads/UKMEC200506.pdf). These criteria represent an adaptation, for UK practice, of previous WHO Medical Eligibility Criteria, and classify a range of medical conditions into eligibility categories by contraceptive type. The eligibility criteria range from 1 (no restriction for use of the contraceptive method with that condition) to 4 (where use of the contraceptive method represents an unacceptable health risk) (see Table 1 ).

The UKMEC categories for each of the contraceptive methods for women with HIV/AIDS are summarized in tabular form at the end of this section ( Table 3 ).

5.1.1.2 General Contraception Management. Development of managed care networks or integrated SRH services will ensure that patients have access to both HIV services and reproductive health services, including contraception. HIV-positive women requiring contraception should be given information about all methods of contraception and be supported in making an informed choice. Women should be provided with the most effective method of contraception that is acceptable to them. All women should receive detailed information - both verbal and written, if possible - to enable them to choose a method and use it effectively. Counselling should be sensitive to cultural differences and religious beliefs. Women should be informed when contraceptives are used outside the product licence and there should be clear written documentation in the notes as to why this is necessary. Women may be taking multiple pills in terms of their HIV disease, and factors around adherence should be taken into account when choice of contraceptive method is made.

Most available methods of contraception may be considered in HIV-positive women and are safe and effective; however, special considerations need to be made in women currently taking or about to commence ART.

All women being considered for contraception should have an appropriate medical and sexual history taken as part of routine assessment. Transmission of HIV and other STIs must also be discussed and screening for STIs should be offered where appropriate. Safe sex should always be promoted when prescribing contraception. Women who have HIV-negative partners (i.e. discordant couples) should also be advised of the availability of PEPSE.

Contraceptive efficacy is variable between methods ( Table 2 ), and a method that is effective in preventing HIV transmission (i.e. condoms) may offer less contraceptive efficacy than some other methods. For an individual woman to achieve optimal protection against pregnancy and HIV transmission, she may need to use dual methods.

5.1.1.3 Barrier Methods. 5.1.1.3.1 Condoms. The effectiveness of both male and female condoms in preventing pregnancy is dependent on correct and consistent use, with unplanned pregnancy rates in the first year of use of around 2% and 5%, when used perfectly. Condoms are, of course, user-dependent and can only be used at time of coitus. In practice with typical use, failure rates of around 15% and 21% can be anticipated.[192] Latex and non-latex male condoms have been shown to offer similar efficacy in pregnancy prevention.[193] Male condom use offers a high degree of protection against HIV sexual transmission[194] and STIs[195] if used correctly. The consistent use of a condom for each episode of vaginal intercourse in serodiscordant couples reduces the risk of HIV transmission by 80%.[196] There may be issues around negotiation of male barrier methods and patients should be counselled and supported appropriately.

The female condom consists of a polyurethane sheath, with a flexible ring at either end. The upper ring is placed in the upper vagina, and the lower ring covers the introitus.[197] Laboratory evidence suggests that female condoms also provide protection against STIs,[198,199] although widespread use of female condoms has been limited.

N-9 is the only spermicide available in the UK. It is a mucosal irritant and has been shown to increase the risk of HIV transmission. It offers no protection against other STIs such as gonorrhoea or chlamydia[198,199] and does not reduce pregnancy rates when compared to non-spermicidally lubricated condoms.[198] Condoms lubricated with N-9 are therefore not recommended.[200]

Dual protection or 'doubling up' - using both barrier and either hormonal or intrauterine contraception - is the most effective way to both prevent pregnancy and reduce horizontal transmission of HIV. In addition, use of effective contraception will inevitably reduce cases of vertical transmission to the neonate, by preventing unplanned pregnancies. Nonetheless, some women with HIV will decide to use condoms alone, for prevention of both transmission and pregnancy. In such circumstances, women should be aware of emergency contraception, and know how to access a supply in a timely manner. Emergency contraception is more effective the earlier it is used, and providers should consider advanced provision of emergency contraception for women to keep at home and use as required.

UKMEC categorizes HIV infection, whether using HAART or not, and AIDS as category 1 for both male and female condom use, i.e. there is no restriction on use of the method.

5.1.1.3.2 Diaphragms and caps. Diaphragms cover the cervix and part of the vaginal wall, and caps cover only the cervix. With both methods relatively large areas of the vaginal mucosa remain exposed, thus permitting potential viral transmission. In addition, caps and diaphragms are recommended to be used with N-9; as outlined earlier, this would not be appropriate in a woman who is HIV-positive or when there is a significant risk of HIV. UKMEC therefore recommends that the risks of a diaphragm or cap generally outweigh the benefits (UKMEC category 3).

5.1.1.4 Hormonal Contraception. Hormonal contraceptive methods are among the most widely used family planning methods worldwide. They include the COC, the combined contraceptive patch, POP, injectable progestogens and the progestogen implant.

5.1.1.4.1 Combined oral contraceptive pill. The COC is the most commonly used contraceptive method by women in the general UK population aged 16-49 years.[201] In current practice, low-dose COCs containing 20-35 µg ethinylestradiol (EE) in combination with a progestogen have replaced older COCs containing 50 µg EE or more. Progestogens include norethisterone, levonorgestrel, desogestrel, gestodene, norgestimate and the newest progestogen, drospirenone. COCs act on the hypothalamic-pituitary-ovarian axis to inhibit ovulation and also have some effects on cervical mucus and the endometrium. The method offers high contraceptive efficacy, with a perfect use failure rate of 0.1% in the first year, although typical-use failure rate may be up to 5%.

This method is safe and effective for women with HIV who are not taking ART and is categorized as UKMEC 1. There is limited evidence suggesting no association between COC use and changes in HIV viral load or CD4 cell counts in HIV-positive women. Overall evidence is inconsistent regarding whether there is increased risk of HIV-1 acquisition with hormonal contraception use. One meta-analysis of 28 studies showed a positive association between COC use and HIV-1 risk,[202] although many other studies have shown no association. A recent study with over 6000 participants showed no association between either combined oral or injectable progestogen contraception and HIV.[203] Hormonal contraceptives cannot replace the ability of barrier methods to prevent transmission of HIV and other STIs; condoms should therefore be recommended in conjunction with any hormonal method.

For women taking HAART, some ARV drugs may reduce the efficacy of hormonal contraception ( Table 4 ). A few agents increase contraceptive steroid levels, but more commonly levels are reduced. ARV drugs such as PIs (e.g. lopinavir, ritonavir) and NNRTIs (e.g. nevirapine) are metabolized by the CYP3A4 liver enzyme system and can affect liver enzymes (see Table 3 ). Women with HIV may use combination therapy where one or more drugs may affect the liver enzymes. The contraceptive efficacy of COC may be reduced by such drugs. Unfortunately, few studies have been published that investigate the pharmacokinetics of oestrogen and progestogen with ARV drugs and none on the effect on contraceptive efficacy. Serum concentrations of EE were reduced when women taking a 50-µg EE COC were also using ritonavir, but no pregnancies have been documented.[204] In HIV-positive women on non-enzyme-inducing ART, UKMEC category 2 applies - i.e. the advantages of the method generally outweigh the risks.

When enzyme-inducing ART is used the condition remains UKMEC category 2, but additional contraceptive precautions should be advised. Guidance from the Faculty of Family Planning and Reproductive Health Care advises that a COC with at least 50 µg EE (e.g. Norinyl-1®, or a combination of a 20 µg and 30 µg pill such as Mercilon plus Marvelon) is used in those women who are using liver-enzyme-inducing drugs and wish to start or continue the COC. Additional contraceptive protection, such as condoms, is also strongly advised.[205] Some women may opt to use an alternative method of contraception that is not affected by enzyme-inducing drugs, such as an intrauterine method, but this will not be acceptable to everyone. It is important to consider that use of a COC, even with an enzyme inducer, is likely to confer better contraception than no method at all.

The COC is metabolized by the liver and its use in women with cirrhosis is considered UKMEC 3/4. Caution should also be exercised in women with abnormal liver function because of co-infection with hepatitis B and/or C, or history of alcohol misuse.

There will also be potential drug interactions between other drugs that induce liver enzymes and hormonal contraception. Some HIV-positive women who may not be receiving ART may be on medication to treat tuberculosis, for example. Use of rifampicin decreases the contraceptive effectiveness of the COC[206,207] and an alternative or additional contraceptive method should be considered for such women.

5.1.1.4.2 Combined contraceptive patch. The transdermal patch delivers EE (20 µg) and norelgestromin (150 µg) daily, and is applied weekly for 3 weeks followed by a 7-day patch-free interval. A Cochrane systematic review concluded that self-reported compliance was better with the patch compared to the COC, although overall efficacy is similar for both methods. There are no currently available data on the use of the patch in women using liver enzyme-inducing drugs such as ART. Although first-pass metabolism in the liver is avoided with transdermal administration of hormones, the effectiveness of the patch is likely to be reduced by drugs that induce hepatic enzyme activity. The patch is classified by UKMEC as category 1 for HIV-positive women not using ART, and category 2 for women on ART (i.e. as for COC). If a woman on enzyme-inducing ART opts to use transdermal contraception, then additional contraception, usually in the form of condoms, should be strongly encouraged.

5.1.1.4.3 Progestogen-only pill. Traditional POPs contain levonorgestrel, norethisterone or ethynodiol diacetate and mainly work by thickening cervical mucus, and by a lesser effect on the endometrium. The newer desogestrel POP works by inhibiting ovulation in the majority of women. POP is classified as UKMEC category 1 for women with HIV and not on HAART. ARV drugs have the potential to either increase or (more commonly) decrease the bioavailability of progestogen steroid hormones in the POP, thereby reducing contraceptive efficacy. Thus use of POP by women on HAART is classified as category 2, and use of an additional method of contraception, such as condoms, should be advised.

5.1.1.4.4 Long-acting injectable progestogens. These are DMPA, which is given every 12 weeks, and norethisterone enantate (NET-EN), which is given every 8 weeks. DMPA is the more commonly used injectable in the UK and is a safe and effective method of contraception for women with HIV. The use of condoms will, of course, continue to be encouraged to reduce transmission of virus.

The metabolism of DMPA is unaffected by liver enzyme-inducing drugs and thus DMPA can be used in women taking ART without loss of contraceptive efficacy. DMPA and NET-EN should continue to be given at the usual intervals of 12 and 8 weeks, respectively. Women on long-term DMPA have been shown to have an increased risk of low bone density, and FSRH guidance suggests discouraging women at high risk of low bone density from using DMPA.[208] HIV infection itself has been found to be associated with reduced bone density, and some ARTs can further reduce bone density. Women may continue to opt for DMPA after discussion, but it may be prudent in such circumstances to offer a baseline bone density scan prior to initiation of DMPA.

5.1.1.4.5 Progestogen-only sub-dermal implants. The etonogestrel implant is an extremely effective contraceptive and acts by suppressing ovulation. It lasts for 3 years and is a safe and effective method of contraception for women with HIV not on ART (UKMEC 1). Use of enzyme-inducing medication is likely to increase the metabolism of etonogestrel, leading to a potential reduction in efficacy. Thus concomitant use of HAART reclassifies etonogestrel to category 2 in HIV-positive women, and an additional contraceptive method may be recommended.

5.1.1.5 Intrauterine Contraception. 5.1.1.5.1 Levonorgestrel intrauterine system. The LNG-IUS is used by 1% of women aged 16-49 years using contraception in the UK, and lasts for 5 years. LNG is released into the uterine cavity at a constant dose of 20 µg per day and the main mode of action is a direct local effect on the endometrium, preventing implantation. Women in the UK who are HIV-positive may be offered an IUS after risk assessment and STI testing, if appropriate.

There is no evidence that the effectiveness of the IUS is reduced when taking liver enzyme-inducing drugs, and use of the LNG-IUS is classified as UKMEC 2 for women with HIV both on and off HAART. Initiation of a LNG-IUS in women with AIDS is classified as category 3 (risks outweigh the advantages), but women with AIDS and a LNG-IUS already in situ may continue to use the method under category 2. Condom use will again be encouraged concomitantly, to reduce virus transmission. The majority of women with an LNG-IUS will have a significant reduction in menstrual bleeding within a few months of insertion. This reduction in blood loss may be relevant in reducing the risk of horizontal transmission by reduction in viral shedding.

5.1.1.5.2 Copper-bearing intrauterine devices. Copper-bearing IUDs (Cu-IUDs) act by preventing fertilization and inhibiting implantation, and are used for between 5 and 10 years, depending on the device. IUD use is a safe and effective method of contraception for women living with HIV, with no evidence of increased complications when compared to HIV-negative women. In addition, there is no evidence of increased transmission of HIV to partners when a Cu-IUD is in situ. Women in the UK who are HIV-positive may be offered an IUD after risk assessment and testing as indicated. Condom use should also be advised, as for all methods.

5.1.1.6 Emergency Contraception. Women will require emergency contraception to reduce the risk of unplanned pregnancy when unprotected intercourse has occurred or when their usual method of contraception has failed. Women with HIV infection not on ART may be offered progestogen-only emergency contraception (POEC) if within 72 h of sexual intercourse, or insertion of a copper IUD as an alternative if within 5 days (UKMEC 1).

Levonorgestrel 1.5 mg recently became available in the UK[209] and replaces previous regimens with two doses of 0.75 mg. POEC is available as an over-the-counter preparation, as well as on prescription from general practices, some accident and emergency departments, and sexual and reproductive clinics.

The latest guidance from the FFPRHC[209] states that women using liver enzyme-inducing drugs should be advised that an emergency IUD is the preferred option for emergency contraception because this method is unaffected by concomitant drug use. If this is not acceptable or appropriate, the guidance also states that the dose of levonorgestrel should be increased by 100% for women who are using liver enzyme-inducing drugs - that is, women should be advised to take two tablets of levonorgestrel (1.5 mg), total dose 3 mg, as soon as possible and within 72 h of unprotected sexual intercourse. No studies are available to confirm that this dose increase is required and the recommendation is based on clinical judgement. Use in these circumstances is outside the product licence. Women should be advised of this and it should be documented in the notes.

5.1.1.7 Key Points and Recommendations.

  • Consistent condom use should be encouraged in conjunction with an additional contraception method.

  • For HIV-positive women not on ART, all available contraceptive methods are suitable, although N-9 spermicide should be avoided.

  • Because of induction of liver enzymes, COC, POP and etonogestrel, implant may be less effective in those on HAART. Nonetheless, there is a role for these methods in conjunction with an additional method.

  • The efficacy of DMPA, LNG-IUS and Cu-IUD are not known to be affected by liver enzyme inducers, and offer very effective contraception for those on HAART.

  • A Cu-IUD is the recommended method of emergency contraception for women on HAART. If POEC is used, a doubling of the standard dose to 3 mg stat (immediately) is recommended.

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