1. Contraceptive Care for Women with HIV Infection and their Partners
Kimberly McClellan, MSN, WHNP-BC, CRNP
Director Women's Health
AIDS Care Group, Chester PA

2. This teleconference is made possible by the Cooperative Agreement #5U65PS from the Centers for Disease Control and Prevention
Special thanks to AETC, Title X and CDC EMCT partners
The views expressed by the speakers and moderators do not necessarily reflect the official polices of the Dept. of Health and Human Services nor does mention of trade names or organizations imply endorsement by the U.S. Government.

3. Objectives
Describe considerations for selecting appropriate contraceptive and compare options for women living with HIV
Explain specific consideration related to hormonal contraception and antiretroviral treatment
Identify issue related to hormonal contraception and HIV progression, transmission or acquisition

4. Benefits of Contraception for HIV-Positive Women
Prevents unintended pregnancy
Half of all pregnancies in U.S. are unintended
Allows women to plan a pregnancy that
Is well timed
Occurs in optimal health
Minimizes risks for perinatal transmission
Centers for Disease Control and Prevention. (2010, April 30). Unintended pregnancy prevention: Home. Retrieved from
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. (2011, September 14). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Retrieved from

5. Special Considerations Regarding HIV and Contraception
Potential drug interaction with antiretrovirals (ARVs)
Possible effects on HIV transmission
Possible effects on HIV acquisition
Possible effects on HIV progression

6. Typical Effectiveness of Contraception
HIV-positive
women generally
have the same
options as
uninfected women
Talking Points
One of the most important strategies to decrease the proportion of unintended pregnancies is the use of effective family planning methods.
This chart shows the relative typical effectiveness of various family planning methods – typical effectiveness refers to how effective the different methods are at preventing pregnancy during actual use, including inconsistent or incorrect use.
At the top you will find male and female sterilization, along with long acting reversible contraceptives or LARCS, which include intrauterine devices or IUDs and contraceptive implants.
More commonly used, and less effective methods, are listed below such as injectables and oral contraceptives shown in the second row from the top and condoms shown in the third row from the top.
References
Adapted from: WHO. Family Planning: A Global Handbook

7. US Medical Eligibility Criteria for Contraceptive Use

8. US Medical Eligibility Criteria: Categories

9. Oral contraceptives
Same medical criteria as for HIV-uninfected women if woman is NOT on ART
Drug-drug interactions are possible between ARVs and hormonal contraceptives (HCs)
HCs are metabolized by same pathways and cytochrome P450 enzymes as many PIs and NNRTIs
These interactions can cause changes in the efficacy of the ARV or contraception
ACOG (2010), Gynecologic care for women with human immunodeficiency virus. Practice Bulletin #117.

10. Hormonal Contraception: Alternate Delivery Methods
Combined Patch is a thin plastic square worn on body
Releases estrogen and progestin through the skin
Works by preventing ovulation
Efficacy
Limited research suggests may be more effective than COCs
Decreased efficacy in women over 90 kg

11. Hormonal Contraception: Alternate Delivery Methods
Limited research suggests health risks and benefits are similar to COCs
Side Effects
Skin irritation or rash where patch is applied
Changes in bleeding pattern
Headaches
Nausea
Vomiting
Breast tenderness
Abdominal pain
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

12. Hormonal Contraception: Alternate Delivery Methods
Combined Vaginal Ring is placed into the vagina
Releases estrogen and progestin
Works by preventing ovulation
Efficacy
Limited research suggests may be more effective at preventing pregnancy than COCs
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

13. Alternative Delivery Methods
Limited research suggests risks and benefits similar to COCs
Side effects
Changes in bleeding pattern
Headaches
Nausea
Breast tenderness
Vaginitis
Leukorrhea/increase in Lactobacillus
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

14. Alternate Delivery Methods
These delivery methods also vulnerable to drug interactions
One small study found significant interaction between the estrogen and progestin hormones of the patch and lopinavir/ritonavir
More research needed on these delivery methods
Vogler, M.A., Patterson, K. et al. (2010, December 1). Contraceptive efficacy of oral and transdermal hormones when co-administered with protease inhibitors in HIV-1 infected women: Pharmacokinetic results of ACTG trial A5188. J Acquir Immune Defic Syndr, 55(4),

15. DMPA Injectable (IM,SQ) progestin only contraception
Given every 3 months
Works by preventing ovulation
Efficacy
97% effective as commonly used
Over 99% effective when used as directed (3 pregnancies per women)
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

16. Contraceptive Implants
Thin rods or tubes containing a progestin hormone.
Provide effective contraception for at least 3 yrs.
Suppresses ovulation and changes cervical mucus.
Menstrual irregularities in most users.

17. Intrauterine devices (IUDs)
No known drug interactions
No increase in shedding of HIV
2 types
Copper (Paragard) works for 10 years, may be associated with heavier menses, periods regular)
Levonorgestrel IUD (Mirena) works for 5 years, reduces menstrual blood loss (is FDA-approved as a treatment for menorrhagia), periods scant and not regular

18. Medical Eligibility Criteria for IUD*
LNG-IUD
Cu-IUD
Initiation
Continuation
High Risk for HIV 2
HIV Infection
AIDS 3
Clinically Well on ARV Therapy
*Adapted from: U.S. medical eligibility criteria for contraceptive use.
Centers for Disease Control and Prevention. (2010, May 28). U.S. medical eligibility criteria for contraceptive use, 2010: Adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR Early Release, 59.
Category 2: A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.
Category 3: A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

19. IUD and HIV Considerations
No higher risk in HIV-positive women over uninfected women for
Complications
Infections
IUD use not associated with increased risk for transmission to sex partners
Women with IUD in place who develop AIDS should be monitored for pelvic infection
Centers for Disease Control and Prevention. (2010, May 28). U.S. medical eligibility criteria for contraceptive use, 2010: Adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR Early Release, 59.

20. Hormonal Contraception and NNRTI Interaction Table
Efavirenz (EFV)
No effect on oral ethinyl estradiol
Decreased active metabolites of norgestimate (levonorgestrel AUC ↓ 83%; norelgestromin ↓64%)
Implant: ↓ etonogestrel
Levonorgestrel AUC ↓58%
A reliable method of barrier contraception must be used in addition to HC due to decreases in progestin levels.
A reliable method of barrier contraception must be used due to reports of contraceptive failure.
Effectiveness of emergency contraception may be diminished
Etravirine (ETR)
Ethinyl estradiol AUC ↑22%
Norethindrone: no significant effect
No dosage adjustment necessary
Nevirapine (NVP)
Ethinyl estradiol AUC ↓20%
Norethindrone AUC ↓19%
DMPA: no significant change
Use alternative or additional methods
No dosage adjustment needed
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. (2011, September 14). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Retrieved from

21. Hormonal Contraception and Ritonavir-boosted PI Table
Atazanavir/ritonavir (ATV/r)
↓ Ethinyl estradiol
↑ Norgestimate
Oral contraceptive should contain at least 35 mcg of ethinyl estradiol. OCs containing progestins other than norethindrone or norgestimate have not been studied.
Darunavir/ritonavir (DRV/r)
Ethinyl estradiol ↓44%
Norethindrone AUC ↓14%
Use alternative or additional method.
Fosamprenavir/ritonavir (FPV/r)
Lopinavir/ritonavir (LPV/r)
Ethinyl estradiol AUC ↓42%
Norethindrone AUC ↓17%
Saquinavir/ritonavir (SQV/r)
↓Ethinyl estradiol
Tipranavir/ritonavir (TPV/r)
Ethinyl estradiol AUC ↓48%
Norethindrone: no significant change
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. (2011, September 14). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Retrieved from

22. Hormonal Contraception and PIs without Ritonavir Table
Atazanavir (ATV)
Ethinyl estradiol AUC ↑48%
Norethindrone AUC ↑110%
Oral contraceptive should contain no more than 30 mcg of ethinyl estradiol or use alternative method. OCs containing less than 25 mcg of ethinyl estradiol or progestins other than norethindrone or norgestimate have not been studied.
Fosamprenavir (FPV)
With APV: ↑Ethinyl estradiol and ↑norethindrone; ↓APV 20%
Use alternative method.
Indinavir (IDV)
Ethinyl estradiol AUC ↑25%
Norethindrone AUC ↑26%
No dose adjustment.
Nelfinavir
Ethinyl estradiol AUC ↓47%
Norethindrone ↓18%
Use alternative or additional method.
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. (2011, September 14). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Retrieved from
Adapted from: Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States.

23. Hormonal Contraception and CCR5 antagonist/integrase inhibitor table
Maraviroc (MVC)
No significant effect on ethinyl estradiol of levonorgestrel
Safe to use in combination
Integrase inhibitor
Raltegravir
No significant drug effect
No dose adjustment necessary
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. (2011, September 14). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Retrieved from
Adapted from: Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States.

24. Condoms Efficacy Pregnancy prevention as commonly used
Male condom 85%
Female condom 79%
Pregnancy prevention when used correctly and consistently
Male condom 98%
Female condom 95%
Male condom is 80-95% effective at preventing HIV transmission when used correctly and consistently
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

25. Dual Contraceptive Use
Condom use should be encouraged for women
To prevent HIV/STI acquisition
Condom use should be encouraged in HIV-positive women
To prevent HIV transmission
Prevent STI acquisition
As an adjuvant to contraceptives
Condoms alone have a failure rate of 15%-21% at preventing pregnancy
American College of Obstetricians and Gynecologists (ACOG). (2010, December). Gynecologic care for women with human immunodeficiency virus. Obstetrics and Gynecology, 116(6),
World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. (2007) Family planning: A global handbook for providers. Baltimore and Geneva: CCP and WHO.

26. Spermicides: Not recommended
Spermicides are not recommended by CDC
Disrupt cervical mucosa
Potentially increase viral shedding
Increase transmission of HIV to uninfected partners
Diaphragms and cervical caps are not encouraged by the CDC due to concerns about their use with spermicides
Centers for Disease Control and Prevention. (2010, May 28). U.S. medical eligibility criteria for contraceptive use, 2010: Adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR Early Release, 59.
World Health Organization. (2009). Medical eligibility criteria for contraceptive use fourth edition, Retrieved from

27. Female and Male Sterilization
Contraceptive sterilization is the most widely used method of family planning
Clients should be advised that sterilization should be considered permanent
Male-vasectomy: Cutting/occluding both vas deferens
1st yr failure rate-0%-0.5%
Female-sterilization
Transabdominal
Transcervical
Tubal sterilization
Occlusion method

28. Hormonal Contraception and HIV Acquisition: WHO Technical Statement
Most studies found no statistically significant association between oral contraception and HIV acquisition
Evidence on injectable HC varied with some studies showing increases between 48% to 100% and other studies reporting no association
Due to inconsistent data and limitations of the studies performed WHO rated the current evidence as low
World Health Organization. (2012, February 16). Hormonal contraception and HIV: Technical statement. Retrieved from

29. HIV Transmission and Hormonal Contraception: WHO Technical Statement
Recent observational study found a 2-3 increase in HIV transmission in women using injectables over oral contraception
Findings from studies assessing HC and genital HIV shedding are not consistent
Studies assessing HC and viral load generally showed no negative effect
WHO rates the evidence for HIV transmission and injectable use as low and HIV transmission and oral contraception as very low
World Health Organization. (2012, February 16). Hormonal contraception and HIV: Technical statement. Retrieved from

30. HIV Disease Progression and Hormonal Contraception: WHO Technical Statement
None of the 10 observational studies conducted found a significant association between hormonal contraception and HIV progression
One randomized controlled trial found an increased risk of progression for HC users compared to copper IUD users
Due to flaws in this study --- high rates of method switching and loss to follow-up --- the evidence for HC and HIV progression is rated as low
World Health Organization. (2012, February 16). Hormonal contraception and HIV: Technical statement. Retrieved from

31. WHO Recommendations
No restriction on the use of any hormonal contraceptive method for HIV-positive women or women at high risk for HIV infection
Critical importance must be placed on the consistent and correct use of condoms for the prevention of HIV acquisition or transmission
Most concern is focused on the evidence of HIV acquisition and DMPA because a causal relationship is neither established nor ruled out
Voluntary use of contraception by HIV positive women who wish to prevent pregnancy continues to be an important PMTCT strategy
World Health Organization. (2012, February 16). Hormonal contraception and HIV: Technical statement. Retrieved from

32. Thank you!
Contact the FXB Center with questions or comments, or for a copy of the slide set:
Mary Jo Hoyt