Clinical Updates on PrEP TasP amp Assisted Reproductive Technologies 4232018 UCSF Mission Bay Monica Hahn amp Guy Vandenberg Outline Overview of preconception health for serodifferent ID: 815779
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Slide1
Provider Update: HIV & Safer Conception:Clinical Updates on PrEP, TasP & Assisted Reproductive Technologies
4/23/2018 - UCSF Mission Bay
Monica Hahn & Guy Vandenberg
Slide2OutlineOverview of preconception health for serodifferent couples
Cases:
PrEP
(Pre-Exposure Prophylaxis)
TasP
(Treatment as Prevention)
Assisted Reproductive Options
Low Tech
High Tech (AKA Assisted Reproductive Technologies)
Bonus case (extra credit)
Resources
Q&A and Discussion
Slide3Poll: True or False?If you ARE living with HIV and are pregnant, your baby will always be born with HIV (unless your viral load is undetectable)If you are NOT living with HIV and you are pregnant, your baby can be born with HIV if your partner or sperm donor is living with HIV
Slide4Multiple Choice PollWithout ART or PrEP, what percentage of babies born to a person living with HIV would acquire HIV?
100%
65 to 99%
45 to 65%
15 to 45%
<10%
Slide5Framing: Reproductive Justice and Sex PositivityReproductive Justice: The human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities.
(
SisterSong
)
Sex positivity:
Simply the idea that all sex, as long as it is healthy and explicitly consensual, is a positive thing.
(Women and Gender Advocacy Center)
Slide6Goals of HIV-centered preconception health Optimize overall health for everyone: Healthy diet, exercise, vaccines, avoid tobaccoScreen for, reduce risk for, treat STIs
Reduce exposure to potentially harmful medications and substances
Check on
Reprotox
,
Lactmed
Take prenatal vitamin/folic acid
Prevent HIV transmission to partner and infant
ACOG Practice Bulletin No 117; December, 2010
Slide7Integrating HIV sexual & reproductive health into primary care
All
patients are
asked about reproductive desires and sexual health in sex-positive way
Goal: Planned and well-timed pregnancies, reduce unintended pregnancies
PLWH are given support for disclosure to loved ones
Partners of PLWH are linked to care, counseled about tools to reduce their risk of HIV
Shared decision-making for patients and affected family
Overall health of all HIV-affected families is optimized
Zero HIV transmissions to infants or to negative partners
Support given before, during and after pregnancy
Slide8Case: Julia & Fernando Julia, 34yo WLWH, diagnosed in El Salvador many years agoCD4 790, undetectable VL for >7 years since immigrating to the US100% adherence since starting ARTHas desired starting a family with her
fiance
, Fernando, who is not LWH.
Was told by prior providers it was impossible for her to have children safely due to her HIV status. No known fertility issues.
What are their options?
Slide9Poll: Options for serodifferent couplesSperm washing with in-clinic insemination is the first line risk reduction technique for
serodifferent
couples
Home insemination using Fernando’s sperm or sperm from a donor
He can take daily
PrEP
to lower his risk
He can take post-coital PEP to lower his risk
Plain old-fashioned
condomless
sex is a perfectly safe option
Surrogacy
Adoption
Slide10Goals for Julia & FernandoFor serodifferent/mixed status couples:
Prevent HIV transmission to negative partner
Avoid sexual transmission of HIV
–
through
TasP
,
PrEP
, PEP, condoms if appropriate
Recommend checking HIV viral load monthly during pregnancy
Recommend STI screening for all
Avoid perinatal transmission to infant
Slide11The Science Behind TasP
HIV Treatment as Prevention: HPTN052
Serodifferent
couples with CD4 = 350 - 550/
uL
(1,763 couples)
Two arms: “Early therapy” = ARVs immediately vs. “Delayed therapy” = ARVs after CD4 decline
46 linked transmissions: 43 in delayed, 3 in early (93-96% reduction)
NO linked transmissions when partner on ART x 3 months and virally suppressed
There are personal
and
public health benefits from ART use.
PARTNER study 2016 and Opposites Attract study 2017:
Serodifferent
couples with undetectable PLWH
No linked transmissions to negative partners through
condomless
sex when PLWH undetectable. Included significant numbers of MSM.
Cohen et al. NEJM 2011, Cohen et al. IAS 2015, Cohen et al. NEJM 2016; Rodgers et al. JAMA 2016;
Bavinton
et al, IAS 2017
Slide12#UequalsU
“HIV stigma is a public health crisis, and yet many people in positions of power are still sitting on their hands, overstating risk and not sharing this life changing information! We need people to move away from controlling people with HIV and toward trusting people with HIV.”
(Bruce Richman, Prevention Access Campaign 2017)
”People who take ART daily as prescribed and achieve and maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner.”
CDC (September, 2017)
Slide13HIV & PregnancyTaking ART, maintaining an undetectable viral load before conception and throughout pregnancy, avoiding breastfeeding, and giving the infant medicine as prescribed, virtually eliminates the risk of HIV transmission.
(Mandelbrot 2015)
Slide14Case: Janet & JamesJanet: 23yo F with no significant PMHx and no primary care homeHopes to start a family with James, her male partner LWH, taking ARVs and has undetectable viral load in the past year, with some past difficulty with adherence in setting of alcohol and substance use disorder, now in recovery
She has been told by providers that she would be irresponsible to consider having a child with this partner due to HIV risk to herself and her potential child, and should never have sex without condoms.
Slide15Poll: What do you recommend for this couple?Sperm washing with in-clinic insemination Just have plain old-fashioned condom-less sex
–
no need for anything else!
She should always use condoms, and use PEP if the condom breaks
D. She can add taking
PrEP
to lower her risk
E. I’m not sure. I need more information
Slide16What is PrEP?
Truvada
: (
tenofovir
300 mg /
emtricitabine
200 mg)
Prevents HIV replication, reduces risk of HIV by more than 90% (sexually), and by more than 70% (for PWID)
Orally once a day
–
efficacy decreases with less frequent dosing
How long do you need to be on
PrEP
before it is effective?
7 days for rectal exposure
~20 days for
cervicovaginal
exposure
~20 days for blood exposure
Side effects
10-20% with initial side effects (“start-up syndrome”: headache, abdominal pain, nausea, diarrhea, weight loss) that usually resolve spontaneously
Slide17Safety of PrEP in preconception/pregnancyThought to be safe in preconception, pregnancy and breast/
chestfeeding
Antiretroviral Pregnancy Registry: No evidence of adverse effects or birth defects among fetuses exposed to
PrEP
Studies of women who took
PrEP
around preconception period: No adverse events and no HIV transmissions to negative partners
Possible association with decreased infant head circumference
–
unlikely to be clinically significant
US Perinatal Guidelines and British HIV Association statements defend safety of
tenofovir
in pregnancy
daCosta
, Machado et al. 2011, Watts, Huang et al. 2011, Knapp,
Brogly
et al. 2012;
Floridia
,
Mastroiacovo
et al. 2013
;
Siberry
, 2012;
Mugo
, 2012;
Vernazza
et al, 2011;
Seidman
et al, 2016;
Siberry
et al, 2012; Fowler et al 2016.
Slide18Patient education materials
Slide19Back to Janet and James…Counseling: Suppressed VL in James throughout pregnancy and breastfeeding ensures HIV not transmitted to Janet, which eliminates risk of perinatal transmission to infant
If acute HIV transmission during pregnancy or breastfeeding for Janet, risk of perinatal HIV transmission to infant increases
Monthly VL in James during pregnancy and breastfeeding (coordinate with his PCP, sign ROI)
HIV
Ab
/Ag screening test at least one per trimester, more if known
viremic
exposure (and consider PEP)
Slide20Heffron 2016
PrEP
provides
little added benefit
when:
The partner living with HIV is on ART and consistently undetectable
There are no other outside partners contributing risk for HIV
Is there any added benefit to
PrEP
if already using
TasP
?
Slide21Janet chooses to take PrEPJanet’s reasons for choosing
PrEP
Reduce pressure on James, uncertainty of his level of adherence
Shared responsibility/teamwork approach, reduced anxiety
Sense of control and agency for Janet in complex power dynamics of relationship
Each couple’s situation is different
–
our job is help them choose the tools that are right for them
Slide22Switching Gears
Slide23What is Conception?
Slide24Where could HIV be present?Semen (sperm’s “medium”)
Seminal Fluid (60 to 75%)
Other Fluids (26 to 35%)
Blood (not usually present)
Spermatozoa (2 to 5%)
Repro tract
(ova’s “house”)
Vaginal fluids
Uterine secretions
Blood (possibly present)
Ova (oocytes / egg cells)
All of the above,
except
d)
Slide25How to Increase Your Chances of ConceptionTimed coitus: Coitus during windows of peak fertility (around ovulation)Ovulation predictor kit
Apps for menses tracking
Definition of infertility:
1 year trying with frequent coitus/timed coitus if under age 35, or 6 months trying if over age 35.
Slide26Preparing for ConceptionWomen:Hormone level tests (3rd day of cycle)And/or hysterosalpingogram
Men:
Semen analysis
Slide27Assisted Reproductive TechnologyLow Tech
Ovulation Induction (
Clomid
)
85% ovulate
43% conceive in 3 cycles
(
big drop-off after 3 months!)
“Traditional” Surrogacy
without medical assistance
Same as with intercourse
Vaginal Insemination
without medical assistance
Same as with intercourse
Success Rates
Slide28Low Tech Case: Miriam & Rashid
F & M couple, trying to conceive x 3 years
Miriam is on ART, undetectable VL
Tried herbals and
Clomid
w/o success
(Sub-standard) semen analysis is unhelpful
After considering other options, Miriam and Rashid decide to ask Rashid’s (twin-) brother Musa to donate sperm. He agrees
One year later: Miriam gives birth - to twins!
Slide29Note: The people in this picture are not Miriam & Rashid
Slide30Assisted Reproductive TechnologyHigh Tech:Sperm-Washing
IUI with medical- assistance
Donor-sperm from sperm-bank
Donor-egg
Egg-freezing & storage
In-Vitro Fertilization (IVF)
($150 to $250/ejaculate)
($300 - $800)
($775 - $855/vial)
(donor-fee: ~$7,000, IVF: $15 – $20K/cycle)
($12,500 - $20,000 for 5 years)
Cost-range: $15,000 - $20,000/cycle
Success rate: ~40%
Slide31Fertility Clinic Case: Zula & AliF&M couple desiring pregnancyBoth are living with HIV (on ART, VL<40)Zula is >42
y.o
: ineligible for SFGH-REI
Referral/agreement with local Fertility Clinic:
All lab-work etc. done at SFGH and sent to clinic
Consults done for free (!!)
IVF done at low cost & paid for by
pt’s community
First cycle to start within next 4 weeks
!
Slide32Assisted Reproductive Options for PLHA in the San Francisco Bay AreaSFGH: REIReferral criteria:
Women <42 years old
Referral questions:
Reproductive & other PMH
Periods (regular/irregular)
Length of time trying
Labs
(preferred, not required)Semen analysis, HSP, TSH, 3-day FSH and estradiol
Private Clinics
(partial list)
Kaiser Permanente (Fremont)
Laurel Fertility Care
NOVA IVF (Mountain View)
Pacific Fertility Center
Spring Fertility
Stanford (Sunnyvale)
UCSF
Note: costs, coverage, and services offered vary by clinic
Slide33Bonus Case: Steve & Guy
1992: asked to donate semen
1993: considering adoption
1994-1996: “hiatus”
1997: reconsidering adoption
1998: orientation, adoption classes, home inspections, foster parent classification
Plusses:
interracial couple, open to adopt “special needs” kids, health care and foster care experience
Not a factor:
HIV diagnosis
Slide34Slide352016: settled into “
unclehood
”
Slide36Slide37Thank you!Please contact us with any questions!Monica Hahn: monica.hahn@ucsf.eduGuy Vandenberg: guy.vandenberg@ucsf.edu
Slide38HIVEonline.orgResources for providers
Integrated resources on sexual & reproductive health
Videos of how to counsel patients
Sample order sheets
Resources for patients
Information sheets on prevention options in and around pregnancy (Spanish & English)
Videos of patient experiences
Slide39Reproductive Health Clinic
at SFGH Ward
86.
Call:
415-206-2482
or email:
guy.vandenberg@ucsf.edu