Современное лечение ВИЧ: лечение ВИЧ у женщин.2017/Contemporary Management of HIV. Management of HIV in Women.2017

Contemporary Management of HIV:
Management of HIV in Women
This program is supported by an independent educational grant from
ViiV Healthcare.

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Program Director and Core Faculty
Program Chair
Joseph J. Eron, Jr., MD
Professor of Medicine and
Epidemiology
University of North Carolina
School of Medicine
Director, AIDS Clinical Trials
Unit
University of North Carolina
Chapel Hill, North Carolina
Kathleen E. Squires, MD
W. Paul and Ida H. Havens
Professor of Infectious
Diseases
Director, Division of
Infectious Diseases
Sidney Kimmel Medical
College of Thomas Jefferson
University
Philadelphia, Pennsylvania

Faculty Disclosure Information
Joseph J. Eron, Jr., MD, has disclosed that he has received
consulting fees from Gilead Sciences, Janssen, Merck, and
ViiV and funds for research support from AbbVie, Gilead
Sciences, Janssen, and ViiV.
Kathleen E. Squires, MD, has disclosed that she has
received consulting fees from Bristol-Myers Squibb, Gilead
Sciences, Janssen, Merck, and ViiV and funds for research
support from Gilead Sciences.

Peer Review Disclosure
Barry S. Zingman, MD
Medical Director, AIDS Center
Clinical Director, Infectious Diseases, Moses Division
Professor of Clinical Medicine, Albert Einstein College of
Medicine
Montefiore Medical Center
The University Hospital for Albert Einstein College of
Medicine
Barry S. Zingman, MD, has no real or apparent
conflicts of interest to report.

HIV in Women in the United States
 Women constitute ~ 25% of HIV-infected population[1]
– ~ 11% do not know they are infected
 2014: 19% of 44,073 new HIV diagnoses were in women[1]
– 87% attributed to heterosexual sex, 13% to IDU
 2013: among women diagnosed with HIV, 84% linked to HIV
care within 3 mos, 55% retained in care[1]
 2012: 39% of women with HIV receiving ART, 30% with viral
suppression[1]
 2014: analysis from 33 US jurisdictions demonstrated durable
viral suppression in 44% of women living with diagnosed HIV[2]
1. CDC. HIV among women. 2016.
2. Crepaz N, et al. CROI 2017. Abstract 31.

ART Safety and Efficacy
in Women

Case 1: Selecting Initial ART for an Older
Woman
 61-yr-old woman presents with
MS “flare”
– Emergency department
clinician notes leukopenia and
suggests HIV screen
 Past medical history
– MS treated with glatiramer
 Social history
– Married but no sexual relations
with husband for several yrs
– Has 2 sexual partners; states
“no need for condoms”
 Acute HIV infection:
Date HIV
Ag/Ab
Multi-
spot1/2
HIV-1
RNA,
copies/mL
CD4+,
cells/
mm3
8/3 Reactive Negative -- --
8/5 -- -- 2,843,413 220
8/13 -- -- 6,286,300 407
Other Labs Result
HIV GT WT
HLA-B*5701 Negative
Hemoglobin, g/dL 11.0
Creatinine, mg/dL 1.2
eGFR, mL/min 64

A. EVG/COBI/FTC/TAF
B. EVG/COBI/FTC/TDF
C. DTG/ABC/3TC
D. DTG + FTC/TAF
E. DTG + FTC/TDF
F. RAL + FTC/TAF
G. RAL + FTC/TDF
H. Something else
 61-yr-old woman diagnosed with acute HIV
 HIV-1 RNA 6,286,300 c/mL; CD4+ count 407 cells/mm3
 HIV WT; HLA-B*5701 negative
 CrCl 1.2 mg/dL; eGFR 64 mL/min Slide credit: clinicaloptions.com
Case 1: The pt requests an ART regimen
with as few pills as possible. Which of the
following regimens do you recommend?

DHHS and IAS-USA Guidelines:
Recommendations for Initial ART
 Recommendations may differ based on baseline HIV-1
RNA, CD4+ count, CrCl, eGFR, HLA-B*5701 status,
HBsAg status, and osteoporosis status
 Recommendations do not differ by sex
Class
First-line ART
DHHS Recommended IAS-USA Recommended
INSTI  DTG/ABC/3TC
 DTG + FTC/TDF or FTC/TAF
 EVG/COBI/FTC/TDF
 EVG/COBI/FTC/TAF
 RAL + FTC/TDF or FTC/TAF
 DTG/ABC/3TC
 DTG + FTC/TAF
 RAL + FTC/TAF
Boosted PI  DRV + RTV + FTC/TDF or FTC/TAF
DHHS Guidelines. July 2016.
Günthard HF, et al. JAMA. 2016;316:191-210.
Bolding indicates single-tablet regimen.

Initial ART: Renal Impairment
DHHS Guidelines. July 2016. Günthard HF, et al. JAMA. 2016;316:191-
210. ABC/3TC [package insert]. September 2015. EVG/COBI/FTC/TDF
[package insert] January 2017. FTC/TAF [package insert]. April 2016.
FTC/TDF [package insert]. April 2016.
Renal Considerations for Recommended Initial Regimens
ABC/3TC  Do not use if CrCl < 50 mL/min
FTC/TDF
 EVG/COBI/FTC/TDF: do not start if CrCl < 70 mL/min; d/c if CrCl < 50 mL/min
 FTC/TDF: dose adjust if CrCl 30-49 mL/min; do not use if CrCl < 30 mL/min
FTC/TAF  No dose adjustment needed if CrCl ≥ 30 mL/min, regardless of coformulation
Class
First-line ART
DHHS Recommended IAS-USA Recommended
INSTI  DTG/ABC/3TC
 DTG + FTC/TDF or FTC/TAF
 EVG/COBI/FTC/TDF
 RAL + FTC/TDF or FTC/TAF
 DTG/ABC/3TC
 DTG + FTC/TAF
 RAL + FTC/TAF
Boosted PI  DRV + RTV + FTC/TDF or FTC/TAF

Why Studies of ART in Women Are
Important
 Interactions of ART with
steroid hormones/
contraception
 Safety of ART in
pregnancy
 Differences between
women and men in:
– Physiology
– Weight distribution
– Pharmacodynamics
– Body dysmorphia
 Women constituted only
19.2% of participants in
systematic review of ART
trials[1]
 Phase III data emerging
from studies of modern
ART regimens in women:
GRACE WAVES, ARIA
1. Curno MJ, et al. J Acquir Immune Defic Syndr. 2016;71:181-188. Slide credit: clinicaloptions.com

GRACE: DRV/RTV + Optimized
Background Regimen in Tx-Exp’d Pts
 North American, open-label phase IIIb trial evaluating sex-
based differences in efficacy and safety (N = 429)
– 67% of participants were women, 84% of participants were black
or Hispanic
 Specific measures are needed to retain HIV-positive women in
clinical trials
Wk 48 Outcome, % Women Men P Value
Virologic response
By ITT analysis
Excluding pts who withdrew*
50.9
73.0
58.5
73.5
.067
.44
Discontinuations 32.8 23.2 .042
*For reasons other than virologic failure.
Currier J, et al. Ann Intern Med. 2010;153:349-357. Slide credit: clinicaloptions.com

WAVES: EVG/COBI/FTC/TDF vs ATV +
RTV + FTC/TDF in Tx-Naive Women
 International, randomized, controlled, double-blind phase III trial
 Fewer discontinuations for AEs with EVG/COBI (n = 5 vs n = 19)
 Among pts with VF and resistance data, 3 developed resistance
mutations to study drugs in ATV arm vs 0 in EVG arm
EVG/COBI/FTC/TDF QD +
Placebos for ATV, RTV, and FTC/TDF QD
(n = 289)
ATV + RTV + FTC/TDF QD +
Placebo for EVG/COBI/FTC/TDF QD
(n = 286)
Women
with HIV-1 RNA
≥ 500 copies/mL;
no previous ART;
eGFR ≥ 70 mL/min
(N = 575)
Wk 48
Squires K, et al. Lancet HIV. 2016;3:e410-e420.
Stratified by
HIV-1 RNA
and race
Primary Endpoint:
Wk 48 HIV-1 RNA
< 50 c/mL
87%
81%
Δ: 6.5%
(95% CI:
0.4-12.6)

WAVES: Safety Outcomes
AE, % EVG/COBI/FTC/TDF
(n = 289)
ATV + RTV + FTC/TDF
(n = 247)
Discontinuations due to AE 2.4 7.0
Serious AE 8 10
Drug-related serious AE 1 2
Any drug-related AE 28 49
Drug-related AE occurring
in ≥ 5% of pts in either arm
 Icterus < 1 12
 Nausea 11 10
 Vomiting 5 3
 Cholestasis or jaundice 0 10
 Rash 2 5
 Headache 5 2
Squires K, et al. Lancet HIV. 2016;3:e410-e420. Slide credit: clinicaloptions.com

ARIA: DTG/ABC/3TC vs ATV + RTV +
FTC/TDF in Tx-Naive Women
 International, randomized, open-label phase IIIb trial
 Fewer discontinuations for AEs with DTG (n = 4 vs n = 7 with ATV)
 Among pts with VF and resistance data, 1 developed resistance
mutation to study drugs in ATV arm vs 0 in DTG arm
DTG/ABC/3TC QD
(n = 248)
ATV + RTV + FTC/TDF QD
(n = 247)
Women
with HIV-1 RNA
≥ 500 copies/mL;
no previous ART;
HLA-B*5701 negative;
CrCl ≥ 50 mL/min
(N = 495)
Wk 48
Johnson M, et al. HIV Glasgow 2016. Abstract P035.
Hagins D, et al. IDWeek 2016. Abstract 949.
Stratified by
HIV-1 RNA
and CD4+ count
Primary Endpoint:
Wk 48 HIV-1 RNA
< 50 c/mL
82%
71%
Δ: 10.5%
(95% CI:
3.1-17.8)

ARIA: Safety Outcomes
Orrell C, et al. AIDS 2016. Abstract THAB0205LB.
AE, %
DTG/ABC/3TC
(n = 248)
ATV + RTV + FTC/TDF
(n = 247)
Discontinuations due to AE 4 7
Serious AE 5 8
Fatal AE < 1* 0
Drug-related serious AE 0 1
Any AE 79 80
Grade 2-4 AE 46 55
Drug-related AE occurring
in ≥ 5% of pts in either arm
33 49
 Nausea 13 14
 Diarrhea 5 7
 Dyspepsia 2 6
 Ocular icterus 0 7
 Headache 2 6
 Jaundice 0 5
*1 death deemed unrelated to study drugs.

Study 104/111: EVG/COBI/FTC/TAF vs
EVG/COBI/FTC/TDF in Tx-Naive Women
 Wk 48 results of phase III studies
 In women, at Wk 48 EVG/COBI/FTC/TAF associated with
numerically less spine and hip BMD loss, significantly less
decline in eGFR, numerically greater decline in proteinuria
Orkin C, et al. EACS 2015. Abstract 798.
EVG/COBI/FTC/TAF EVG/COBI/FTC/TDF
Wk48HIV-1RNA<50c/mL(%)
100
80
60
40
20
0
95
87
92 91
n = 126 111 674 673
Women Men
0 4 8 12 16
0.2
7.9
15.6
Favors TAFFavors TDF
Treatment Difference in Women (95% CI)
-16 -12 -8 -4

Switch to EVG/COBI/FTC/TAF in
Virologically Suppressed Women
 WAVES: international, randomized, double-blind phase III trial
comparing EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF in 575
treatment-naive women[1]
 Women completing 48 wks of ATV/RTV + FTC/TDF in WAVES
rerandomized in current trial[2]
 No treatment-emergent resistance in either treatment arm
 At Wk 48, pts receiving TAF had higher mean % increase in lumbar spine
and total hip BMD, improved renal safety markers, and greater lipid
increases vs TDF regimen, but no difference in TC:HDL ratio
Switch to EVG/COBI/FTC/TAF
(n = 159)
Continue ATV/RTV + FTC/TDF
(n = 53)
Virologically suppressed
women who completed
48 wks of ATV/RTV +
FTC/TDF in WAVES trial
(N = 212)
Wk 48 Virologic
Efficacy*
Difference: 7.5%
(95% CI: -1.2 to
19.4)
94%
87%
1. Squires K, et al. Lancet HIV. 2016;3:e410-e420.
2. Hodder S, et al. CROI 2017. Abstract 443.

Virologic Outcomes Generally Similar in
Men vs Women in FDA Meta-analysis
 Analysis included 20,328
pts from 40 RCTs
(2000-2008)
 Virologic efficacy:
proportion with HIV-1 RNA
< 50 c/mL at 48 wks
Soon GG, et al. AIDS Patient Care STDS. 2012;26:444-453.
Treatment Naive: Wk 48 Efficacy
Difference (95% CI)
StudyTreatmentArms
Pt Population Overall Sex-Based
Efficacy Difference, %
(95% CI)
Treatment naive -1.34 (-4.54 to 1.87)
Treatment
experienced
-2.13 (-5.56 to 1.30)
-100% -50% 0% 50% 100%
Overall
Favors Males
(n = 5)
Favors Females
(n = 3)

Key Initial ART Considerations for
Older HIV-Infected Women
 Recommended initial ART regimens apply for both women and
men
 Key considerations relevant to older women reflect
comorbidities commonly associated with aging
– Cardiovascular disease risk:
– Data are conflicting on association between ABC and CVD event risk
– Many experts avoid ABC in pts with elevated CVD risk to err on the
side of caution
– Recent findings from D:A:D cohort suggest DRV/RTV may be
associated with increased CVD event risk[1]
– Bone health: reduced bone loss with TAF vs TDF
– Renal health: more favorable renal safety with TAF vs TDF
Ryom L, et al. CROI 2017. Abstract 128LB. Slide credit: clinicaloptions.com

Reproductive and Gynecologic
Health Management in
Women With HIV

Case 2: Managing ART and Contraception
 25-yr-old woman with 3-yr history of HIV infection
– Current ART regimen: DRV + RTV + FTC/TDF
– Cervical dysplasia
– Vaginal candidiasis
 Social history
– She has a new boyfriend who is also HIV positive but is
virally suppressed on ART
– They are currently monogamous and using condoms, but
her boyfriend would like to consider other contraceptive
options

A. Continue DRV + RTV + FTC/TDF
B. Switch to EVG/COBI/FTC/TAF
C. Switch to EVG/COBI/FTC/TDF
D. Switch to DTG/ABC/3TC
E. Switch to DTG + FTC/(TAF or TDF)
F. Switch to RPV/FTC/(TAF or TDF)
G. Something else
 25-yr-old woman receiving suppressive DRV + RTV
+ FTC/TDF
 Initiates low-dose estrogen for oral contraception
The pt chooses to start oral contraception
with low-dose estrogen. Which of the
following strategies do you recommend
regarding her ART regimen?

What ARVs Are Compatible With
Contraception?
 Several PIs, EFV, and EVG/COBI-based regimens have
drug interactions with combined oral contraceptives
– Decrease or increase in blood levels of ethinyl estradiol,
norethindrone, or norgestimate could potentially:
– Decrease contraceptive efficacy
– Increase estrogen-related or progestin-related AEs (eg,
thromboembolism)
 Women receiving ARVs with significant interactions with
hormonal contraceptives should use an additional or
alternative contraceptive, consider ARV switch
DHHS Guidelines. October 2016. Slide credit: clinicaloptions.com

Drug Interactions Between Hormonal
Contraceptives and ARVs
WHO Guidelines. June 2016.
Hormonal
Contraceptive
NRTI PI NNRTI INSTI
Any* ATV LPV DRV RTV EFV NVP ETR RPV DTG RAL
EVG/
COBI
Combined oral
contraceptives
Etonogestrel or
levonorgestrel
implant
Transdermal
ethinyl estradiol
Norethisterone
(norethindrone)
DMPA
injectable
No clinically significant interaction or interaction unlikely
Potential interaction that may require monitoring or regimen alteration
*Includes 3TC, ABC, d4T, ddI, FTC, TAF, TDF, ZDV.

Cervical Cancer Screening Guidance for
HIV-Infected Women
 DHHS guidelines vary by age group
*For normal/negative test results.
DHHS. Adult and adolescent opportunistic infection.
Test
When to
Start
Repeat
Screening*
Women < 30 Yrs of Age
Pap test only
Younger than 21 yrs
Within 1 yr of sexual
activity onset; no later
than 21 yrs
Age 21-29 yrs
At time of initial HIV
diagnosis
Every 12 mos; after
3 consecutive normal
tests, switch to every
3 yrs
Women ≥ 30 Yrs of Age
Pap test only Pap and HPV cotest
At time of initial HIV
diagnosis
At time of initial HIV
diagnosis or 30 yrs of
age
 Every 12 mos;
after 3 consecutive
normal tests,
switch to every
3 yrs
 Continue lifelong
 Every 3 yrs if tests
negative
 Continue lifelong

Guidance on Cervical Cancer Screening
Follow-up for HIV-Infected Women
HIV-Infected Women < 30 Yrs or ≥ 30 Yrs but Screened by Pap Only
Test Result Recommendation
Normal Pap
 Continue routine screening every 12 mos
 If 3 consecutive normal results, extend screening
interval to 3 yrs
Abnormal ASCUS Pap
 Reflexive HPV test if available and refer for
colposcopy if positive
 If HPV test not available, repeat cytology in 6-12
mos and refer for colposcopy if abnormal
Abnormal ≥ LSIL Pap  Refer for colposcopy

Guidance on Cervical Cancer Screening
Follow-up for HIV-Infected Women
HIV-Infected Women ≥ 30 Yrs Screened by Pap/HPV Cotesting
Test Result Recommendation
Normal Pap; HPV-  Continue routine screening every 3 yrs
Normal Pap; HPV+
 Repeat cotesting in 12 mos
 If either follow-up test is abnormal, refer for
colposcopy
Normal Pap; HPV 16+ or
16/18+
 Refer for colposcopy
Abnormal Pap; HPV+  Refer for colposcopy

STI Screening Recommendations for HIV-
Infected Women
 At baseline and annually:
– Syphilis serology
– Urogenital NAAT for gonorrhea and chlamydia
– Depending on sexual practices, consider pharyngeal and
anal screening
– Vaginal trichomoniasis test
 If bacterial vaginosis suspected, look for clue cells on
wet mount under microscope
CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. Slide credit: clinicaloptions.com

Current Recommendations for HPV
Vaccination in HIV
 HPV vaccination indicated for all HIV-infected individuals
aged 9-26 yrs
HPV Vaccination Recommendations for HIV-Infected Women
 Use either bivalent, quadrivalent, or 9-valent HPV recombinant
vaccine
− 9 valent: types 6, 11, 16, 18, 31, 33, 45, 52, 58
− Quadrivalent: types 6, 11, 16, 18
− Bivalent: types 16, 18
 Each is administered at 0, 1-2, and 6 mos
DHHS. Adult and adolescent opportunistic infection. Slide credit: clinicaloptions.com

Case 3: HIV Diagnosis Late in Pregnancy
 30-yr-old Kenyan woman
presents with UTI in her
third trimester of
pregnancy (33 wks’
gestation)
– Received single-dose
NVP during her first
pregnancy > 5 yrs ago
– Has received no prenatal
care during this
pregnancy
Labs Result
HIV-1 RNA, copies/mL 560,000
CD4+ cell count,
cell/mm3
230
WBC, cell/mm3
4400
Hemoglobin, g/dL 11.0
Creatinine, mg/dL 0.6
HBV Negative
HLA-B*5701 Negative

A. DRV/RTV + TDF/FTC
B. RAL + TDF/FTC
C. DRV/RTV + TDF/FTC + DTG
D. DRV/RTV + TDF/FTC + RAL
E. DTG/ABC/3TC
F. Something else
 30-yr-old woman presents late in third pregnancy (33 wks)
with untreated HIV
 Received single-dose NVP during first pregnancy > 5 yrs
ago; no prenatal care during this pregnancy
 HIV-1 RNA 560,000 c/mL; CD4+ cell count 230 cell/mm3
 CrCl 0.6 mg/dL Slide credit: clinicaloptions.com
DHHS Perinatal Guidelines recommend
immediate ART initiation. Which of the following
ART regimens do you recommend for this pt?

DHHS Recommendations: Initial ART in
Pregnant Women
DHHS Perinatal Guidelines. October 2016.
Guideline Status NRTIs PIs INSTIs NNRTIs
Preferred
3TC/ABC
FTC/TDF
3TC + TDF
ATV/RTV*
DRV/RTV*† RAL*§
Alternative 3TC/ZDV LPV/RTV*† EFV*
RPV*‡
Insufficient data
to recommend
FTC/TAF FPV
DTG
EVG/COBI
EVG/COBI
*In addition to 2-NRTI backbone.
†
Must be used BID in pregnancy.
‡
Only if pretreatment HIV-1 RNA ≤ 100,000 copies/mL and CD4+ cell count ≥ 200 cells/mm3
.
§
If adherence concerns or potential for ART discontinuation postpartum, a PI is preferred
over INSTI to reduce resistance risk.

PROMISE: Continuing vs Stopping ART in
Postpartum, Non-Breastfeeding Women
 Randomized trial in Argentina, Botswana, Brazil, China, Haiti,
Peru, Thailand, and United States of women receiving ART
(74% LPV/RTV, 19% ATV/RTV) or stopping ART following
pregnancy
Currier J, et al. AIDS 2016. Abstract THAB0103LB.
Continue ART
(n = 827)
Stop ART*
(n = 825)
HIV-infected, ART-naive (except PMTCT)
postpartum women without guideline-
specified indication for ART, CD4+ cell
count ≥ 400 cells/mm3
, not breastfeeding
(N = 1652)
Randomized within
42 days of delivery
*Restarted ART if CD4+ cell count fell below 350 cells/mm3
or was clearly indicated.
Current analysis reflects median follow-up of 2.31 yrs for Continue ART arm and 2.35 yrs for Stop ART arm.
Pts seen 4 wks post enrollment,
then every 12 wks through 84 wks
after last enrollment

PROMISE: Efficacy and Safety at Median
Follow-up of Approximately 2 Yrs
 Secondary endpoints:
continued ART associated with
lower HIV event rate
Currier J, et al. AIDS 2016. Abstract THAB0103LB.
Outcome, n
(Rate per
100 PY)
Continue
ART
(n = 827)
Stop ART
(n = 825)
HR
(95% CI)
Composite
of HIV/
AIDS-
related or
WHO stage
2/3 events
57 (3.09) 99 (5.49)
0.56
(0.41-0.78)
WHO stage
2/3 events
38 (2.02) 80 (4.36)
0.47
(0.32-0.68)
Primary Efficacy Endpt: AIDS-Defining or
Serious Non-AIDS Event or Any-Cause Death
P = .54
EstimatedProbability
1.00
0.95
0.90
0 48 96 144 192 240
Continue ART
Stop ART
0.6
1.0
0
0.2
0.4
0.8
Wks
Primary Safety Endpt: Gr 3/4 Sign/
Symptom or Gr 2-4 Chem/Hematol. Result
P = .08
EstimatedProbability
0 48 96 144 192 240
Continue ART
Stop ART

DHHS Recommendations: Women on
Suppressive ART Who Become Pregnant
 “In general, HIV-infected pregnant women receiving ART who present
for care during the first trimester should continue treatment during
pregnancy, assuming the regimen is tolerated and effective in
suppressing viral replication”
 How to manage ART when women become pregnant while receiving
newer antiretroviral drugs (with limited PK and safety data in
pregnancy) as part of effective and well-tolerated regimens?
– DHHS emphasizes that maintaining viral suppression is paramount for
both maternal health and prevention of perinatal transmission
– If uncertain about pregnancy safety of drugs within ART regimen,
consultation with HIV perinatal specialist is recommended before
considering a change
– Report all ART exposures in pregnant women to Antiretroviral Pregnancy
Registry
DHHS Perinatal Guidelines. October 2016. Slide credit: clinicaloptions.com

HIV Prevention:
Key Considerations for Women

HPTN 052: ART for Prevention of HIV
Transmission in Serodiscordant Couples
 ART offered to all index pts
in delayed ART arm from
May 2011 after interim
results
– 84% of pts in delayed ART
arm had initiated ART at
Yr 1 and 98% prior to study
closure
 No linked HIV transmissions observed when index participant
stably suppressed on ART
Cohen MS, et al. IAS 2015. Abstract MOAC0101LB.
Safren SA, et al. J Acquir Immune Defic Syndr. 2015;69:234-240.
Partner
Infections, n
(Rate per 100 PY)
Overall
(April 2005 - May 2015)
Early
(4314 PY F/U)
Delayed
(4180 PY F/U)
All 19 (0.44) 59 (1.41)
Linked 3 (0.07) 43 (1.03)
Risk Reduction
With Early ART,
%
All infections 69 --
Linked infections 93 --

Expanded WHO Guidance on PrEP and
HIV Risk in Women
 New WHO guidance recommends considering PrEP for
anyone at substantial risk of HIV infection (ie, HIV
incidence > 3/100 PYs without PrEP)[1]
– Based on individual assessment and local evidence rather
than limiting to specific populations or risk groups
 Women are also at risk of HIV infection[2]
– In 2014 in the US, women made up 19% of estimated
44,073 new HIV diagnoses
 Growing IDU epidemic in the US contributes to HIV risk,
including in women[2]
– 87% (7242) of HIV diagnoses in women in 2014 attributed to
heterosexual sex and 13% (1045) attributed to IDU
1. WHO Guidelines. June 2016. 2. CDC. HIV among women. Slide credit: clinicaloptions.com

CDC PrEP Guidelines for Heterosexually
Active Adults at Ongoing, Very High Risk
 Substantial risk categories
– HIV-positive sexual partner
– Recent bacterial STI
– High number of sex partners
– History of no/inconsistent use of condoms
– Commercial sex worker
– In high prevalence network or area
CDC. Preexposure prophylaxis for the prevention of HIV infection in the
United States—2014: a clinical practice guideline. Slide credit: clinicaloptions.com

PrEP Is Effective Among Women:
Adherence Is Key
 In meta-analysis of 18 studies, adherence was a significant
moderator of PrEP effectiveness[1]
– Age and sex did not moderate PrEP effectiveness
 In FEM-PrEP, FTC/TDF not effective in heterosexual women[2]
;
assessment of drug levels showed very low adherence[3]
 Studies establishing PrEP effectiveness included substantial
numbers of women
– In TDF2, 45.7% of participants were women[4]
– In a VOICE subgroup analysis, women with detectable plasma
tenofovir had a 47% risk reduction for HIV infection[5]
– In Partners PrEP subgroup analysis of women younger than 30 yrs
of age, TDF was 77% and FTC/TDF 72% protective[6]
References in slidenotes Slide credit: clinicaloptions.com

Partners PrEP: Oral PrEP in
Serodiscordant Heterosexual Couples
 HIV-discordant couples from Kenya and Uganda with HIV+
partner not receiving ART (N = 4747 couples)
HIV Incidence[1]
HIVIncidence(per100PY)
1.99
0.65
67%
reduction
(P < .001)
0.50
75%
reduction
(P < .001)
Placebo TDF FTC/TDF
2
1.5
1
0.5
0
1. Baeten JM, et al. N Engl J Med. 2012;367:399-410.
2. Murnane PM, et al. AIDS. 2013;27:2155-2160.
PrEP Efficacy
Subgroups
(Women)[1] Group n
%
(95% CI)
P
Value
All women
PBO 619
TDF 595
71 (37-
87)
.002
FTC/TDF 566
66 (28-
84)
.005
Partner
plasma
HIV-1 RNA
> 50,000 c/mL
PBO 154
TDF 144
84 (29-
96)
.02
FTC/TDF 146
72 (13-
91)
.03
Younger than
30 yrs of age
PBO 194
TDF 202
77 (29-
92)
.01Slide credit: clinicaloptions.com

Emerging PrEP Strategies: How They May
Affect Women
Strategy Details
Long-acting
injectable
ARVs
 Cabotegravir LA IM injection every 12 wks well tolerated in
men at low risk of HIV infection in double-blind, placebo-
controlled randomized phase IIa study (ÉCLAIR)[1]
 This strategy now being evaluated in both men and women[2]
Vaginal ring
containing
ARVs
 MTN-020/ASPIRE[3,4]
and IPM-027[5]
double-blind,
randomized phase III trials demonstrated efficacy and safety
of dapivirine vaginal ring (ring replaced every 4 wks) for
preventing HIV infection in women:
• HIV protection efficacy vs placebo in overall study populations
27% (P = .046) in ASPIRE[3,4]
and 31% (P = .040) in IPM-027[5]
• Higher prevention efficacy among women older than 21 yrs
1. Markowitz M, et al. CROI 2016. Abstract 106. 2. ClinicalTrials.gov.
NCT02178800. 3. Baeten JM, et al. CROI 2016. Abstract 109LB.
4. Baeten JM, et al. N Engl J Med. 2016;[Epub ahead of print].
5. Nel A, et al. CROI 2016. Abstract 110LB. Slide credit: clinicaloptions.com

Key Take-home Points
 Women living with HIV have been underrepresented
in ART clinical trials
– Post-registrational studies for the most recently
approved ARV drugs have provided efficacy and safety
data indicating these drugs are safe and effective in
women
– Data informing the use of newer agents during
pregnancy are still lacking (EVG/COBI, DTG, TAF)

Key Take-home Points
 Comprehensive management of women living with HIV
should incorporate gynecologic care including:
– Cervical HPV infection/cervical dysplasia screening
– Routine STI screening
 For women of reproductive age, care should also include:
– Discussion of appropriate contraceptive methods to reduce
unintended pregnancy
– Assessment of potential DDIs between ART and hormonal
contraception, if used
 Management of HIV-infected pregnant women is complex
and requires a multidisciplinary approach

Go Online for More CCO
Coverage of HIV!
Additional slidesets on contemporary management of HIV with expert
faculty commentary
Postconference clinical updates available following CROI, the
International AIDS Conference, and IDWeek
clinicaloptions.com/hiv

Современное лечение ВИЧ: лечение ВИЧ у женщин.2017/Contemporary Management of HIV. Management of HIV in Women.2017

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Современное лечение ВИЧ: лечение ВИЧ у женщин.2017/Contemporary Management of HIV. Management of HIV in Women.2017

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