1. Advances in Preventing HIV
Transmission Using Antiretroviral
Therapy: The Role of OB/GYNs
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Originally posted 5/9/2012 at clinicaloptions.com/ss/advances

2. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
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3. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Faculty Disclosures
Jean R. Anderson, MD
Professor
Division of Gynecologic Specialties
Johns Hopkins University
School of Medicine
Baltimore, Maryland
Jean R. Anderson, MD, has no significant financial
relationships to disclose.

4. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Presentation Objectives
 Review current status and continuing challenges for
prevention of mother-to-child transmission (PMTCT) of
HIV in the United States
 Discuss new concepts in HIV prevention using
antiretroviral medications
– Treatment of HIV-infected persons for prevention of
transmission
– Pre-exposure prophylaxis (PrEP)
From treatment vs prevention to treatment meets prevention

5. PMTCT: Proof of concept that
HIV can be prevented using
antiretroviral therapy

6. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
AIDS Diagnoses Among Perinatally
Infected Persons in US: 1985-2009
1000
900 Aged younger than 13 yrs
800 Aged 13 yrs or older
700
Diagnoses (n)
600
500
400
300
200
100
0
85
88
89
90
93
94
01
02
04
07
08
86
87
91
92
95
96
97
98
99
00
03
05
06
09
19
19
19
20
20
20
19
19
19
19
19
19
19
19
19
19
19
19
20
20
20
20
20
20
20
Yr of Diagnosis
CDC 2010.

7. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
OB/GYNs’ Knowledge and Practice of HIV
Screening in Pregnant/Nonpregnant Pts
Percentage of OB/GYNs Reporting That They Would Strongly Suggest HIV
Testing to a Patient who is Pregnant or a Nonpregnant Patient
Characteristic/Risk Factor, % Pregnant Nonpregnant
Current injection drug user 99.3 97.9
Past injection drug user 98.7 92.8
Reports unprotected sex with multiple partners 96.4 85.9
History of blood transfusion between 1978 and 1985 91.9 77.6
Currently being treated for STI 85.4 72.5
Any history of blood transfusion 76.4 47.4
Negative HIV test within past 6 mos 45.8 15.1
No specific risk other than pregnancy identified 56.2 --
Planning a pregnancy -- 35.0
Sexually active with no previous HIV testing -- 34.2
Gray AD, et al. Obstet Gynecol. 2007;110:1019-1026.

8. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Recommendations on HIV Testing of
Pregnant and Nonpregnant Patients
 ACOG,[1] AAP,[2] CDC,[3] and the Institute of Medicine[4]
recommend that all pregnant women be screened for HIV as a
part of routine prenatal care using an opt-out approach
 In addition, CDC has recommended routine opt-out HIV
screening for all patients in all healthcare settings since 2006[3]
and ACOG endorsed these recommendations in 2008[1]
– Patient notified that testing will be performed unless they decline
– Signed consent should not be required
– Prevention counseling not required
– Persons at high risk for HIV should be screened at least annually
1. ACOG. Obstet Gynecol. 2008;112:739-742. 2. AAP HIV Screening Guidelines; 2005. 3. Branson BM,
et al. MMWR Recomm Rep. 2006;55:1-17. 4. Institute of Medicine Perinatal Transmission Guidelines.

9. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Basic Principles of Use of Antiretrovirals
in Pregnancy
 ARVs should be initiated in all HIV-infected pregnant
women regardless of CD4+ cell count or HIV-1 RNA level
 Regimens used should be effective in treatment of
nonpregnant adults and should be safe and well tolerated
– Regimen should consist of 2 NRTIs and either an NNRTI or
a PI, most often with ritonavir boosting
– Include ≥ 1 NRTI with good placental passage
 Earlier initiation more effective in PMTCT
 Women entering pregnancy on ART should continue on
regimen, if effective and tolerated
DHHS HIV Perinatal Guidelines. September 14, 2011.

10. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Current USPHS Classification of
Antiretroviral Drugs in Pregnancy
 Considerations: efficacy, durability, toxicity, convenience, pregnancy PK data,
adverse outcomes for mother/fetus/infant
Drug Class Preferred Alternative Agents Use in Special Insufficient Data
Agents Circumstances
Abacavir, Stavudine,
Zidovudine,
NRTIs Didanosine, n/a n/a
Lamivudine
Emtricitabine, Tenofovir
NNRTIs Nevirapine n/a Efavirenz Etravirine, Rilpivirine
Indinavir/ Darunavir/ritonavir,
Lopinavir/ritona Atazanavir/ritonavir,
PIs ritonavir, Fosamprenavir/ritonav
vir Saquinavir/ritonavir
Nelfinavir ir, Tipranavir/ritonavir
Entry
n/a n/a n/a Enfuvirtide, Maraviroc
inhibitors
Integrase
n/a n/a n/a Raltegravir
inhibitors
DHHS HIV Perinatal Guidelines. September 14, 2011.

11. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Efavirenz in Pregnancy
 Preclinical primate data and retrospective reports in humans raise
concerns about increased risk of neural tube defects[1]
 However, a recent meta-analysis of 1437 women in 19 studies with
first trimester EFV exposure found NO increased risk of birth defects
and only 1 neural tube defect (incidence: 0.07%)[2]
 Treatment change in pregnancy associated with increased risk of
incomplete viral suppression at end of pregnancy[3]
 Draft 2012 BHIVA guidelines recommend that effective EFV-based
antiretroviral therapy be continued in a woman presenting in the first
trimester[4]
– Other guidelines expected to follow suit
1. DHHS HIV Perinatal Guidelines. September 14, 2011. 2. Ford N, et al. AIDS. 2011;25:2301-2304.
3. Floridia M, et al. HIV Clin Trials. 2010;11:303-311. 4. British HIV Association. Guidelines for the
management of HIV infection in pregnant women 2012. Draft guidelines for consultation. January 17,
2012.

12. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Reasons for Residual MTCT
 Woman not offered HIV testing or declines
 Late presentation in pregnancy
 Lack of early and sustained control of HIV-1 RNA,[1-3] due to
– Lack of access to most effective regimens (placental passage, pharmacokinetic
considerations)
– Treatment interruptions in pregnancy[4]
 Maternal genital tract infection[5]
 Acute HIV infection in pregnancy[6,7]
– Pregnancy a period of increased risk for HIV acquisition[8-10]
 Breastfeeding
 Lack of neonatal ARV prophylaxis
1.Tubiana R, et al. Clin Infect Dis. 2010;50:585-596. 2. Joao EC, et al. Int J STD AIDS. 2012;23:44-47. 3. Read PJ, et al.
AIDS. 2012;[Epub ahead of print]. 4. Galli L. et al. Clin Infect Dis. 2009;48:1310-1317. 5. Taha TE, et al. Ann N Y Acad Sci.
2000;918:84-98. 6. Birkhead GS, et al. Obstet Gynecol. 2010;115:1247-1255. 7. Patterson KB, et al. AIDS.
2007;21:2303-2308. 8. Gray RH, et al. Lancet. 2005;366;1182-1188. 9. Bernasconi D, et al. J Clin Virol. 2010;48:180-183. 10.
Moodley D, et al. AIDS. 2009;23:1255-1259.

13. Advances in Preventing HIV Transmission Using Antiretroviral Therapy
clinicaloptions.com/hiv
Unanswered Questions
 When to start lifelong ART?  Should pregnant women stop
ARV drugs after delivery?
– Evidence that earlier treatment
prevents harmful impact of – What is the impact of
ongoing HIV replication[1-3] postpartum discontinuation of
combination regimens used
– New DHHS guidelines solely for PMTCT on short- and
recommend starting at all CD4+ long-term maternal health?
cell counts, but strength of
recommendation varies[4] – With multiple pregnancies?
– < 350 cells/mm3 (AI) – Treatment interruption in
nonpregnant adults assoc. with
– 350-500 cells/mm3 (AII) increased morbidity/mortality[5-7]
– > 500 cells/mm3 (BIII) – PROMISE study[8]
1. Sterne JA, et al. Lancet. 2009;373:1352-1363. 2. Severe P, et al. N Engl J Med. 2010;363:257-265.
3. Kitahata MM, et al. N Engl J Med. 2009;360:1815-1826. 4. DHHS Adult and Adolescent Guidelines. March 27, 2012. 5.
Phillips AN, et al. Antivir Ther. 2008;13:177-187. 6. Lundgren JD, et al. J Infect Dis. 2008;197:1145-1155. 7. Silverberg MJ, et
al. AIDS. 2007;21:1957-1963. 8. ClinicalTrials.gov. NCT01253538.

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Quick-reference PDF Worksheets on Preventing HIV Transmission Using Antiretroviral
Therapy: The Role of OB/GYNs:
 Guidance on HIV Testing in Women
 Guidance on the Use of Antiretroviral
Therapy to Prevent Mother-to-Child
HIV Transmission
 Guidance on Prevention of HIV
Transmission in Serodiscordant Couples
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