Hormonal Hormonal Contraception: Special Contraception: Special Considerations for HIV-Considerations for HIV-infected Womeninfected Women

Lori E. Kamemoto, MD, MPHLori E. Kamemoto, MD, MPH

Hawaii AIDS Clinical Research ProgramHawaii AIDS Clinical Research Program

University of Hawaii School of MedicineUniversity of Hawaii School of Medicine

Miscarriage9%

Intended birth43%

Abortion23%

Miscarriage6%

Mistimed/ unwanted

birth19%

Almost half of all pregnancies Almost half of all pregnancies in the United States are in the United States are unintendedunintended

Pregnancies, 1994(6.3 million)

Unintendedpregnancies

Intendedpregnancies

Alan Guttmacher Institute

Rates higher in:Ages 15-24 y.o.Unmarried women< 200% poverty levelBlack and Hispanic women

Contraceptive hormonesContraceptive hormones

• Ethinyl estradiolEthinyl estradiol• EE dosage EE dosage

decreasing over time decreasing over time 80+ 80+ g g 50 50 g g 20-30 20-30 g g

• Estradiol cypionateEstradiol cypionate• LunelleLunelle

• ProgestinsProgestins• NorethindroneNorethindrone• NorgestimateNorgestimate• Ethynodiol diacetateEthynodiol diacetate• LevonorgestrolLevonorgestrol• DesogestrelDesogestrel• GestodeneGestodene• DrospirenoneDrospirenone• Medroxyprogesterone Medroxyprogesterone

acetateacetate• NorelgestrominNorelgestromin• EtonorgestrolEtonorgestrol

How does hormonal How does hormonal contraception work?contraception work?

• ProgestinsProgestins• prevent ovulationprevent ovulation• affect the time needed for ova to travel through the affect the time needed for ova to travel through the

fallopian tubes, interfering with precise timing needed fallopian tubes, interfering with precise timing needed for fertilization for fertilization

• increase the amount and thickness of mucus at the increase the amount and thickness of mucus at the cervix, decreasing sperm entry cervix, decreasing sperm entry

• decrease the ability of sperm to fertilize an egg decrease the ability of sperm to fertilize an egg • interfere with the implantation of a fertilized egg on the interfere with the implantation of a fertilized egg on the

wall of the uterus wall of the uterus

• EstrogensEstrogens• used mostly to prevent progestin only effect on used mostly to prevent progestin only effect on

menses/tissues, however is associated with increase in menses/tissues, however is associated with increase in contraceptive efficacy (i.e.-”mini-pill” vs. combination contraceptive efficacy (i.e.-”mini-pill” vs. combination pill)pill)

• may also prevent ovulation and affect the time needed may also prevent ovulation and affect the time needed for ova to travel through the fallopian tubes, interfering for ova to travel through the fallopian tubes, interfering with precise timing needed for fertilization with precise timing needed for fertilization

Hormonal contraceptivesHormonal contraceptives

• Oral contraceptivesOral contraceptives• Combination pills (E + P)Combination pills (E + P)• Progestin-only pills (“mini-pill”)Progestin-only pills (“mini-pill”)• Emergency contraception (E + P or P)Emergency contraception (E + P or P)

• Contraceptive patch (E + P)Contraceptive patch (E + P)• Vaginal ring (E + P)Vaginal ring (E + P)• Injectable contraceptivesInjectable contraceptives

• DepoProvera (P)DepoProvera (P)• Lunelle (E + P)-no longer available in U.S.Lunelle (E + P)-no longer available in U.S.

• Progestin IUDProgestin IUD

New hormonal contraception New hormonal contraception methods FDA approved since methods FDA approved since 19951995

• Emergency contraception: PrevenEmergency contraception: Preven®® (1998), Plan B (1998), Plan B®® (1999) (1999)• Monthly injectable: LunelleMonthly injectable: Lunelle®® (2000) (2000)• Vaginal ring: NuvaRingVaginal ring: NuvaRing®® (2001) (2001)• Patch: Ortho EvraPatch: Ortho Evra®® (2001) (2001)• Oral contraceptive with extended period-free regimen: Oral contraceptive with extended period-free regimen:

SeasonaleSeasonale®® (2003) (2003)

• Awaiting approvalAwaiting approval• Single-rod implant: ImplanonSingle-rod implant: Implanon®®

Male hormonal Male hormonal contraceptioncontraception

• WHO studies on testosterone (1996)WHO studies on testosterone (1996)• testosterone IM q weektestosterone IM q week• azoospermia 65% (1 pregnancy)azoospermia 65% (1 pregnancy)• oligospermia 98% (4 pregnancies)oligospermia 98% (4 pregnancies)• male method should produce azoospermia, easily male method should produce azoospermia, easily

reversiblereversible

• Progestins plus testosteroneProgestins plus testosterone• progestins + testosterone more likely to produce progestins + testosterone more likely to produce

azoospermiaazoospermia• norethistrone, DMPA, levonorgestrol, desogestrol, norethistrone, DMPA, levonorgestrol, desogestrol,

etonorgestroletonorgestrol• investigating injectables, patch, implantinvestigating injectables, patch, implant

Contraceptive method use by Contraceptive method use by AgeAge

0%

20%

40%

60%

80%

100%

25-29 30-34 35-39 40-44

Age

Pill

Implant

Injectable

Other

IUD

M/F Steril.

None

Gallup survey, 1998-9

HIV and contraceptive HIV and contraceptive methodmethod• Approximately 70% of all HIV infected women are sexually Approximately 70% of all HIV infected women are sexually

activeactive

• Irish cohort of HIV+ womenIrish cohort of HIV+ women• Only 57% of sexually active used contraceptionOnly 57% of sexually active used contraception

• French SEROCO study HIV+ womenFrench SEROCO study HIV+ women• 20% of sexually active using no contraception20% of sexually active using no contraception• 24% became pregnant and 63% of conceptions ended in abortion24% became pregnant and 63% of conceptions ended in abortion

• African DITRAME project HIV+ womenAfrican DITRAME project HIV+ women• 39% used contraception39% used contraception• 50% of pregnancies were unplanned, and one third were 50% of pregnancies were unplanned, and one third were

terminatedterminated• Postpartum HIV+ vs. HIV –Postpartum HIV+ vs. HIV –

• Tubal ligation: OR 2.9 (1.4-5.9)Tubal ligation: OR 2.9 (1.4-5.9)• BCP: OR 0.2 (0.1-0.5)BCP: OR 0.2 (0.1-0.5)• Condom use: OR 0.7 (0.4-1.3)Condom use: OR 0.7 (0.4-1.3)

• HIV+ vs. HIV-HIV+ vs. HIV-• Consistent condom use: OR 2.31 (1.35-3.94)Consistent condom use: OR 2.31 (1.35-3.94)• BCP: OR 0.54 (0.3-0.98)BCP: OR 0.54 (0.3-0.98)

Hormonal contraceptionHormonal contraceptionBenefitsBenefits

• prevent pregnancyprevent pregnancy• including ectopic pregnancy, miscarriage, abortionincluding ectopic pregnancy, miscarriage, abortion

anemiaanemia• promote cycle regularitypromote cycle regularity ovarian cysts and ovarian cancerovarian cysts and ovarian cancer endometrial cancerendometrial cancer endometriosisendometriosis PIDPID dysmenorrheadysmenorrhea acneacne• probable probable colorectal cancer, colorectal cancer, osteopenia osteopenia

Hormonal contraception Hormonal contraception RisksRisks

thromboembolic phenomenathromboembolic phenomena• including DVT, pulmonary embolism, strokeincluding DVT, pulmonary embolism, stroke

breast cancerbreast cancer heart disease (after 35 y.o. with heart disease (after 35 y.o. with

smoking)smoking) gall bladder disease, hepatomagall bladder disease, hepatoma bone density with DepoProverabone density with DepoProvera• may be associated with hypertensionmay be associated with hypertension• irregular bleedingirregular bleeding• nausea, headaches, weight gainnausea, headaches, weight gain• Current lower dose pills associated with Current lower dose pills associated with

decreased riskdecreased risk

Hormonal contraception and Hormonal contraception and HIV Concerns for WomenHIV Concerns for Women

• Does hormonal contraception influence…Does hormonal contraception influence…• HIV acquisition?HIV acquisition?• HIV disease progression?HIV disease progression?• ARV pharmacokinetics?ARV pharmacokinetics?• HIV transmission to partner?HIV transmission to partner?

• Do ARVs influence contraceptive hormone Do ARVs influence contraceptive hormone pharmacokinetics?pharmacokinetics?

• Which contraceptive method is best for Which contraceptive method is best for HIV infected women?HIV infected women?• efficacyefficacy• least risk vs. benefitleast risk vs. benefit

Acquisition of HIV infection Acquisition of HIV infection in hormonal contraception in hormonal contraception usersusers• Mombasa cohort of female sex workers Mombasa cohort of female sex workers

attending STD clinicattending STD clinic• Depo Provera associated with Depo Provera associated with

increased incidence of HIV-1 infectionincreased incidence of HIV-1 infection• Adjusted Hazard Ratio 2.0 (1.3-3.1)Adjusted Hazard Ratio 2.0 (1.3-3.1)

• Oral contraceptives associated with a Oral contraceptives associated with a trend towards increased HIV-1 trend towards increased HIV-1 infectioninfection• Adjusted HR 2.6 (0.8-8.5)Adjusted HR 2.6 (0.8-8.5)

Martin 1998

Acquisition of HIV infection Acquisition of HIV infection in oral contraceptive usersin oral contraceptive users

• Meta-analysis of 28 studies Meta-analysis of 28 studies • Association between HIV-1 Association between HIV-1

seroprevalence and use of oral seroprevalence and use of oral contraception contraception • All 28 studies: OR 1.19 (0.99-1.42)All 28 studies: OR 1.19 (0.99-1.42)• 21 cross-sectional studies: OR 1.21 21 cross-sectional studies: OR 1.21

(1.01-1.44)(1.01-1.44)• ““8 best studies”: OR 1.60 (1.05-2.44)8 best studies”: OR 1.60 (1.05-2.44)

Wang 1999

Acquisition of HIV infectionAcquisition of HIV infectionwith hormonal with hormonal contraceptioncontraceptionPossible mechanisms that may increase Possible mechanisms that may increase

susceptibility to HIV acquisition with susceptibility to HIV acquisition with hormone usehormone use

• Thinning of vaginal wall with progestinsThinning of vaginal wall with progestins• Increased SIV acquisition with progesterone Increased SIV acquisition with progesterone

associated with vaginal wall thinningassociated with vaginal wall thinning• No evidence that vaginal wall thinning No evidence that vaginal wall thinning

occurs in humansoccurs in humans• Increased cervical ectropion with Increased cervical ectropion with

combination OCPscombination OCPs

Transmission of HIV infection Transmission of HIV infection with hormonal contraceptiveswith hormonal contraceptives

• Increased FGT HIV-1 RNA levels may lead to Increased FGT HIV-1 RNA levels may lead to increased rates of transmission to partnersincreased rates of transmission to partners

• Cervical ectopy associated with increased Cervical ectopy associated with increased HIV genital tract sheddingHIV genital tract shedding

• Oral contraceptives may be associated with Oral contraceptives may be associated with increased HIV genital tract sheddingincreased HIV genital tract shedding

• Contraceptive methods associated with Contraceptive methods associated with irregular or heavier bleeding (progestin-only irregular or heavier bleeding (progestin-only methods, IUD) may be associated with methods, IUD) may be associated with increased risk of HIV transmission to partnerincreased risk of HIV transmission to partner

HIV disease progression HIV disease progression and contraceptive hormones and contraceptive hormones

• Mombasa cohort; Lavreys, etal (2004)Mombasa cohort; Lavreys, etal (2004)• > 1500 high risk women enrolled over 10 > 1500 high risk women enrolled over 10

yearsyears• Able to estimate time of HIV-1 acquisition in Able to estimate time of HIV-1 acquisition in

161 women161 women• Depo Provera use at the time of acquisition of Depo Provera use at the time of acquisition of

HIV associated with HIV associated with HIV-1 RNA at 4 months HIV-1 RNA at 4 months• HIV-1 RNA higher setpoint (+0.33 log copies/cc)HIV-1 RNA higher setpoint (+0.33 log copies/cc)• No association found with OCP useNo association found with OCP use

• Multiple viral variants associated with Depo Multiple viral variants associated with Depo Provera and OCP use (OR 2.7, P=0.003) Provera and OCP use (OR 2.7, P=0.003) compared with no contraceptive usecompared with no contraceptive use

• Women with multiple variants, were more Women with multiple variants, were more likely to have higher viral load and lower CD4likely to have higher viral load and lower CD4

HIV disease progression HIV disease progression and contraceptive and contraceptive hormoneshormones

• Women’s Interagency Study examined Women’s Interagency Study examined plasma HIV-1 RNA and CD4 count on plasma HIV-1 RNA and CD4 count on entry and longitudinally in women on entry and longitudinally in women on hormonal contraceptiveshormonal contraceptives

• No apparent association with HIV-1 No apparent association with HIV-1 RNA levelsRNA levels

• Small increase in CD4 count among Small increase in CD4 count among hormone users of doubtful clinical hormone users of doubtful clinical significancesignificance• Mean increase 27.6 cells/Mean increase 27.6 cells/ll

Cejtin 2003

HIV-associated lipodystrophy HIV-associated lipodystrophy and estrogen receptorsand estrogen receptors

• Increased risk of HIV-associated Increased risk of HIV-associated lipodystrophy in womenlipodystrophy in women

• Estrogen receptor Estrogen receptor (ER (ER) is decreased ) is decreased in subcutaneous adipose tissue with in subcutaneous adipose tissue with HIV+ lipodystrophy HIV+ lipodystrophy

• PIs appear to down-regulate ERPIs appear to down-regulate ER receptors and PI withdrawal led to receptors and PI withdrawal led to increase in ERincrease in ER mRNA mRNA

• ?role of selective estrogen ?role of selective estrogen modulators?modulators?

Barzon 2005

How contraceptive hormones How contraceptive hormones may affect HIV-1 diseasemay affect HIV-1 disease

• Physiologic effects on the vaginal epitheliumPhysiologic effects on the vaginal epithelium• Progesterone implants increased risk of SIV acquisition due to Progesterone implants increased risk of SIV acquisition due to

thinning of vaginal epitheliumthinning of vaginal epithelium• Subsequent human studies have not confirmed thinning of the Subsequent human studies have not confirmed thinning of the

vaginal epithelium with Depo Proveravaginal epithelium with Depo Provera• Hormonal effects on cell-surface CCR5 levelsHormonal effects on cell-surface CCR5 levels

• CCR5 is the main coreceptor in FGTCCR5 is the main coreceptor in FGT• CCR5 increased in biopsies from “progesterone dominant” CCR5 increased in biopsies from “progesterone dominant”

womenwomen• In vitro studies with progesterone showed increased CCR5 and In vitro studies with progesterone showed increased CCR5 and

CXCR4 expressionCXCR4 expression• Direct hormonal effect on virus expressionDirect hormonal effect on virus expression

• Female hormones may govern uterine immune cell synthesis Female hormones may govern uterine immune cell synthesis of cytokines, thus imfluencing the density and action of of cytokines, thus imfluencing the density and action of macrophagesmacrophages

• More studies needed to investigate the role of hormonal More studies needed to investigate the role of hormonal contraception on HIV-1 acquisition, viral setpoint, and viral contraception on HIV-1 acquisition, viral setpoint, and viral diversity in chronic HIV-1 infectiondiversity in chronic HIV-1 infection

Marx 1996, Patterson 1998, Hunt 1998

Drug interactionsDrug interactionsARVs and contraceptive ARVs and contraceptive hormoneshormones• Ethinyl estradiol (EE) and progestins (P) are Ethinyl estradiol (EE) and progestins (P) are

substrates of cytochrome P450 CYP 3A4 substrates of cytochrome P450 CYP 3A4 system of enzymessystem of enzymes• Liver, small intestineLiver, small intestine

• ARVS may:ARVS may:• induce cytochromes, which increase the hepatic induce cytochromes, which increase the hepatic

metabolism of contraceptive hormonesmetabolism of contraceptive hormones• inhibit cytochromes, causing decreased clearance inhibit cytochromes, causing decreased clearance

and increased levels of contraceptive hormonesand increased levels of contraceptive hormones• when both interacting drugs are substrates, the when both interacting drugs are substrates, the

interaction is less predictableinteraction is less predictable• some ARVs exhibit several of these propertiessome ARVs exhibit several of these properties

Drug interactionsDrug interactionsARVs and contraceptive ARVs and contraceptive hormoneshormones

• Most of data from pharmaceutical Most of data from pharmaceutical contraceptive industry research contraceptive industry research involving contraceptive hormone involving contraceptive hormone levels after single dose ARVlevels after single dose ARV• ““use with caution” with certain ARVsuse with caution” with certain ARVs

• No information on longer term No information on longer term contraceptive hormone and ARV usecontraceptive hormone and ARV use• recent completion of ACTG 5093recent completion of ACTG 5093

• No data on hormonal contraceptive No data on hormonal contraceptive efficacy with ARVsefficacy with ARVs

Oral contraceptive failure in Oral contraceptive failure in HIV infected womenHIV infected women

• 2035 HIV+ women in New Orleans2035 HIV+ women in New Orleans• Retrosepctive review of 86 of these Retrosepctive review of 86 of these

women who were on OCPswomen who were on OCPs• 11 women appeared to have become 11 women appeared to have become

pregnant while on Depo Provera or pregnant while on Depo Provera or OCPsOCPs

• ““OCP failure”OCP failure”• PIs: 25%PIs: 25%• NNRTIs: 10%NNRTIs: 10%• No PI or NNRTI: 0%No PI or NNRTI: 0%

Clarke 2004

Drug interactionsDrug interactionsARVs and contraceptive ARVs and contraceptive hormoneshormones• Associated with increase in oral Associated with increase in oral

contraceptive EE levelscontraceptive EE levels• EFV (EE AUC EFV (EE AUC 37%) 37%)• ATZ (EE AUC ATZ (EE AUC 48%, NET AUC 48%, NET AUC 110%) 110%)• IDV (EE AUC IDV (EE AUC 24%, NET AUC 24%, NET AUC 26%) 26%)

• Associated with decrease in oral Associated with decrease in oral contraceptive EE levelscontraceptive EE levels• NVP (EE AUC NVP (EE AUC 29%, NET 29%, NET 18%) 18%)• APV (NET APV (NET 18%) 18%)• RTV (EE AUC RTV (EE AUC 41%) 41%)• NFV (EE AUC NFV (EE AUC 47%, NET AUC 47%, NET AUC 18%) 18%)• LPV/r (EE AUC LPV/r (EE AUC 42%, NET AUC 42%, NET AUC 16%) 16%)

Drug interactionsDrug interactionsARVs and contraceptive ARVs and contraceptive hormoneshormones• NRTIs and oral contraceptivesNRTIs and oral contraceptives

• Majority of NRTIs undergo renal excretion of 50-Majority of NRTIs undergo renal excretion of 50-85%85%

• ABC metabolized via unique pathway and ABC metabolized via unique pathway and excreted renallyexcreted renally

• ZDV undergoes glucoronidation to metabolite ZDV undergoes glucoronidation to metabolite that is excreted renallythat is excreted renally

• ACTG 317 demonstrated no significant difference in ACTG 317 demonstrated no significant difference in glucoronidation of ZDV with OCPsglucoronidation of ZDV with OCPs

• Oral contraceptive effect on ARVsOral contraceptive effect on ARVs• Minimal data existsMinimal data exists• Amprenavir AUC Amprenavir AUC 22% (do not use with OCPs) 22% (do not use with OCPs)• Likely minimal effect on ARVs, but little data Likely minimal effect on ARVs, but little data

existsexists

ACTG 5093, An Open-label, Non-randomized ACTG 5093, An Open-label, Non-randomized Study of the Effect of Depo-Study of the Effect of Depo-Medroxyprogesterone Acetate (DMPA) on the Medroxyprogesterone Acetate (DMPA) on the PK of Selected PI and NNRTI Therapies PK of Selected PI and NNRTI Therapies Among HIV-infected WomenAmong HIV-infected WomenPrimary Objective:Primary Objective:• Determine the effect of DMPA on the PK of selected Determine the effect of DMPA on the PK of selected

ARV therapies among HIV-infected women comparing ARV therapies among HIV-infected women comparing the AUC’s for these drugs prior to DMPA and 4 weeks the AUC’s for these drugs prior to DMPA and 4 weeks laterlater

Secondary Objectives:Secondary Objectives:• Determine whether PK interactions between selected Determine whether PK interactions between selected

ARV’s and DMPA affect the suppression of ovulation.ARV’s and DMPA affect the suppression of ovulation.  

• Evaluate other PK parameters including CEvaluate other PK parameters including Cmaxmax and T and Tmaxmax of selected ARVs before and after DMPA.of selected ARVs before and after DMPA.

• Evaluate the toxicity and safety of any PK interactions Evaluate the toxicity and safety of any PK interactions between ARVs and DMPA.between ARVs and DMPA.

ACTG 5093, An Open-label, Non-randomized ACTG 5093, An Open-label, Non-randomized Study of the Effect of Depo-Study of the Effect of Depo-Medroxyprogesterone Acetate (DMPA) on the Medroxyprogesterone Acetate (DMPA) on the PK of Selected PI and NNRTI Therapies PK of Selected PI and NNRTI Therapies Among HIV-infected WomenAmong HIV-infected Women

ARV PK done before and 4 weeks after DMPA

Enrollment andSubjects Eligible for Analysis

16

16

NRTIs onlyor No Meds(control arm)

20

22

NFVplus NRTIs

15

18

EFVplus NRTIs

1*

IDVplus NRTIs

14

16

NVPplus NRTIs

ACTG 5093, An Open-label, Non-randomized ACTG 5093, An Open-label, Non-randomized Study of the Effect of Depo-Study of the Effect of Depo-Medroxyprogesterone Acetate (DMPA) on the Medroxyprogesterone Acetate (DMPA) on the PK of Selected PI and NNRTI Therapies PK of Selected PI and NNRTI Therapies Among HIV-infected WomenAmong HIV-infected Women• Efficacy of DMPA does not appear to be altered in Efficacy of DMPA does not appear to be altered in

the presence of NFV, EFV, and NVP-based the presence of NFV, EFV, and NVP-based regimens.regimens.

• DMPA was well-tolerated and side effects were DMPA was well-tolerated and side effects were similar to those reported in HIV-negative women similar to those reported in HIV-negative women on DMPA Progesterone levels remained low on DMPA Progesterone levels remained low (<1.5ng/mL) following DMPA administration, with (<1.5ng/mL) following DMPA administration, with no presumptive evidence of ovulation through no presumptive evidence of ovulation through week 12week 12

• Although NVP AUC levels were higher with DMPA, Although NVP AUC levels were higher with DMPA, the increased levels do not appear to be clinically the increased levels do not appear to be clinically relevantrelevant

• DMPA appears to be safe and effective for HIV-DMPA appears to be safe and effective for HIV-infected women taking NFV, EFV, and NVP-based infected women taking NFV, EFV, and NVP-based regimensregimens

• Studies with other HIV protease inhibitors, NNRTIs Studies with other HIV protease inhibitors, NNRTIs and NRTIs (tenofovir) deserve considerationand NRTIs (tenofovir) deserve consideration

ACTG 5188, A Phase II Pharmacokinetic Study ACTG 5188, A Phase II Pharmacokinetic Study of the Transdermal Contraceptive System of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected and Oral Contraceptive in HIV-1 Infected Women on Lopinavir/RitonavirWomen on Lopinavir/Ritonavir

Protease inhibitors associated with a Protease inhibitors associated with a significant decrease in oral significant decrease in oral contraceptive (OC) estradiolcontraceptive (OC) estradiol LPV associated with 42% LPV associated with 42% OC OC

estradiol levelsestradiol levels

Primary Objective: To evaluate the Primary Objective: To evaluate the effect of LPV/r on the PK of EE by effect of LPV/r on the PK of EE by comparing the EE AUC during comparing the EE AUC during ORTHO EVRA® transdermal ORTHO EVRA® transdermal contraceptive patch week 3 in contraceptive patch week 3 in women on LPV/r with the EE AUC women on LPV/r with the EE AUC measured in women who are not measured in women who are not receiving PIs, NNRTIs, or any ARVreceiving PIs, NNRTIs, or any ARV therapy.therapy.

Hypothesis: Transdermal Hypothesis: Transdermal contraceptive patch system (TCS) contraceptive patch system (TCS) estradiol levels will not be estradiol levels will not be significantly affected by PIssignificantly affected by PIs

HIV-1 infected women of HIV-1 infected women of reproductive agereproductive age

Arm A: LPV/r containing Arm A: LPV/r containing regimenregimen

Arm B: NRTI-only Arm B: NRTI-only regimen regimen oror No ARVs No ARVs

6 week PK study (OC & 6 week PK study (OC & TCS)TCS) EEEE NorelgestrominNorelgestromin LPVLPV

54 subjects54 subjects Open to enrollmentOpen to enrollment

Hormonal contraception and Hormonal contraception and HIV Concerns for WomenHIV Concerns for Women

• Does hormonal contraception influence…Does hormonal contraception influence…• HIV acquisition? HIV acquisition? MAYBEMAYBE• HIV disease progression? HIV disease progression? MAYBEMAYBE• ARV pharmacokinetics? ARV pharmacokinetics? PROBABLY NOT for PROBABLY NOT for

most ARVs, altho’ minimal data availablemost ARVs, altho’ minimal data available• HIV transmission to partner? HIV transmission to partner? MAYBEMAYBE

• Do ARVs influence contraceptive hormone Do ARVs influence contraceptive hormone pharmacokinetics? pharmacokinetics? YESYES

• Which contraceptive method is best for Which contraceptive method is best for HIV infected women? HIV infected women? • efficacyefficacy• least risk vs. benefitleast risk vs. benefit

*Association of Reproductive Health Professionals