Updates on PMTCT from Malawi, the country where Option B+ ...regist2.virology-education.com/presentations/2018/10PED/41_Kim.pdf · Research and Implementation Director, Tingathe Program,

10th annual International Workshop on HIV Pediatrics 2018

Session 3: Prevention of Mother-to-child transmission

Steigenberger Hotel Amsterdam, the Netherlands | Saturday, July 21, 2018

Maria H. Kim, MD, MSc

Assistant Professor of Pediatrics, Baylor College of Medicine

Research and Implementation Director, Tingathe Program, Baylor Children’s Foundation Malawi

Implementation Director, Technical Support to PEPFAR Programs in the Southern African Region, Baylor

Children’s Foundation Malawi

Updates on PMTCT from Malawi, the

country where Option B+ started

10th annual International Workshop on HIV Pediatrics 2018 Session 3: PMTCT | July 21, 2018 | Steigenberger Hotel Amsterdam, the Netherlands

Nothing to disclose

• Malawi’s B+ program

• How is it going?A review of Malawi’s current PMTCT data: successes and challenges

• Why has it worked?Enabling factors including task shifting

• What remainsDolutegravir dilemma, further optimizing retention and infant testing, and

closing the gaps

Objectives



• Malawi- the first country to implement Option B+: universal life-long treatment for all pregnant and lactating women

• Option B + theorized benefits: effective reduction of vertical transmission. maternal health, reduced partner transmission, effective, cost-effectiveness, simplified delivery of PMTCT care

• Initiated July 2011

• Resulted in a dramatic and immediate (7-fold) increase in PMTCT uptake

• By 2014, 20+ countries had endorsed Option B+ for their national PMTCT programs

Malawi’s Option B+ Program

Excellent PMTCT coverage

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

MALAWI PMTCT COVERAGE amongst pregnant women living with HIV, 2009 - 2018

Malawi PMTCT coverage (percentage of HIV+ pregnant women receiving any prophylaxis to prevent mother-to-child transmission), Spectrum 2016, 2009 - 2018


Very good ART coverage amongst pregnant women living

with HIV

Malawi Treatment Coverage for HIV+ Women (percentage of HIV+ pregnant women receiving ART for both PMTCT and treatment,, Spectrum 2016, 2009 - 2018


Vertical transmission has decreasedSpectrum estimates

Malawi MTCT Rate at 6 weeks, Spectrum 2016


HIV+ infants are being linked to ART

EID 2-12 mons Confirmed Infected (DNA-PCR) vs Started on ART, MoH DHA data 2015 – 2018Percentage of infants testing positive who are started on ART

90%

97%

59%

93%

83%82%

114%

118%

92%

81%91%

75%

77%69%

73%

80%94%

96%

87%

75%91%88%93%70%

84%

107%

91%

0

20

40

60

80

100

120

140

160

Jan Feb Mar Apr May Jun Jul Aug Sep Nov Dec Oct Jan Feb Mar Apr May Jun Jul Aug Sep Nov Dec Oct Jan Feb Mar

2016 2017 2018

MALAWI EID TEST TO TREATMENT LINKAGE 2 - 12 mons 2016 - 2018

Confirmed Infected + PSHD Started ART


More women are already on ART when becoming pregnant

Malawi Department of HIV and AIDS, National Quarterly Reports Q3 2017

2.1

12 3.3

42

4.2

11

4.1

61

4.3

40

5.0

46

5.2

71

5.3

35

5.1

78 6.5

79

6.6

89

6.5

98

6.3

50

7.4

01

7.2

19

7.4

52

6.8

57 7.9

85

7.7

14

8.2

05

8.4

14

8.5

97

1.1

90

1.2

19

1.2

45

1.2

42

1.1

41

1.2

57

3.5

61

7.5

99

7.4

81

6.0

94 7.9

74

6.6

71

7.0

20

7.1

09

6.7

49

6.5

44

6.8

91

6.3

42 7.0

03

6.4

71

6.1

27

6.2

72

6.4

87

6.2

92

6.6

85

6.6

51 6.4

55

5.9

12

6.3

19

5.5

84

5.7

55

1.3

94

6.8

39

4.4

78

2.6

98

2.6

89

2.2

97

2.2

89

2.1

62

1.8

34

1.7

21

1.8

10

1.5

45

1.8

09

1.7

52

1.7

23

1.5

93 1.6

90

1.7

23

2.0

26

1.8

85

1.4

28

1.2

47

1.6

30

1.5

36

1.6

77

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

2010 2011 2012 2013 2014 2015 2016 2017

PREGNANT AND BREASTFEEDING WOMEN LIVING WITH HIV STARTING OR ALREADY ON ART

Women at maternity or ART when getting pregnant Pregnant women starting ART Breastfeeding women starting ART


Vertical transmission has decreased, but there are gaps

EID Transmission Rate for 2 and 12 mons, MoH DHA data from 2016 - 2018

0,8%0,8%

1,1%

0,9%

0,7%0,8%

1,1%0,9%

0,6%

1,2%

0,9%1,0%1,0%

0,7%0,7%

1,3%1,2%

0,6%

1,4%

1,1%

0,6%0,7%

0,6%0,5%

1,2%

0,7%0,7%

1,2%

2,0%2,1%

1,9%1,9%1,8%

1,9%1,8%

1,3%

1,8%

1,5%

1,9%1,8%

2,0%2,2%

2,3%

2,1%

2,3%2,2%

1,7%

2,0%

1,7%1,7%

1,9%2,0%2,1%

1,9%

0,0%

0,5%

1,0%

1,5%

2,0%

2,5%

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

2016 2017 2018

MALAWI EID TRANSMISSION RATE 2 - 12 mons 2016 - 2018

2 mons Rate 12 mons Rate


Spectrum estimates vertical transmission is 6.9% vs.

Early infant diagnosis program data yield <3%

Early infant diagnosis testing improving but could be

further optimized

EID Coverage 2-12 mons, MoH DHA data 2016 - 2018

57

%

46

%

45

%

50

%

49

%

49

%

54

%

55

%

51

% 57

%

57

%

55

%

76

%

69

%

68

% 79

%

75

%

69

% 80

% 78

%

73

% 81

%

77

%

76

% 82

% 77

%

76

%

0

200

400

600

800

1000

1200

1400

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

2016 2017 2018

Malawi’s Early Infant Diagnosis program, TOTAL CHILDREN REGISTERED vs TOTAL TESTED

2 - 12 months of age 2016 - 2018

Total children registered Total Tested


Retention not optimal

Malawi MoH DHA data Q4 2015 – Q3 2017

76

%

69

%

66

%

65

%

75

%

69

%

66

%

65

%

77

%

71

%

68

%

66

%

76

%

70

%

65

%

65

%

78

%

70

%

64

%

63

%

79

%

73

%

67

%

65

%

80

%

75

%

69

%

65

%

82

%

76

%

69

%

64

%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

6 mons 12 mons 24 mons 36 mons

Pregnant and lactating women alive and on ART 6-, 12-, 24- and 36- months post ART initiation. Q4 2015 - Q3 2017

Q4 2015 Q1 2016 Q2 2016 Q3 2016


Site level variability, 12 month retention Option B+

MoH DHA data 2018


• Political will and strong leadership from the Department of HIV and AIDS

Key factors enabling continued success


• Funding support• Involvement of broad base of key stakeholders including PLHIV and

Implementing partners • Robust data system to track progress with quarterly supervisions• Procurement and supply chain systems tightly monitored• Integration of PMTCT/ART and antenatal care• Malawi’s experience with and innovation around task-shifting

• Malawi’s history of successful task-shifting- enabling non-doctor cadres to initiate ART, helped launch Option B+ in Malawi

• Malawi’s leadership in task-shifting continues to help move Malawi beyond B+ and address ongoing gaps in PMTCT/MCH care

• In 2015, Malawi initiated the HIV Diagnostic Assistant (HDA) program, a new cadre of health worker focused primarily on HIV diagnostic testing (HTC, EID and VL)


Malawi’s innovation: the HIV diagnostic assistant (HDA)

Impact of HIV Diagnostic Assistants (HDAs)

• We reviewed data from 457 HDA sites pre-HDA deployment (October 2013 to June 2015) and post- HDA deployment (July 2015 to December 2017

• We compared several measures including HIV testing, syphilis testing at ANC and early infant diagnosis testing

* Flick RJ, Simon K, Nyirenda R, Namachapa K, Hosseinipour MH, Schooley A, Kavuta E, Theu J, Kazembe PN, Ahmed S, Kim MH. The HIV diagnostic assistant—early findings from a novel HIV testing cadre in Malawi. Publication in progress


• We evaluated changes in the slope and level of these HIV testing measures through single-group interrupted time-series analysis

Number of persons tested for HIV increased post deployment

HIV testing before and after HDA

deployment

Dashed vertical line indicates HDA deployment at July 2015. Solid

lines reflect regression of values before and after deployment. Dashed

horizontal line represents pre-deployment trend projected

(counterfactual outcome).



Trend

before

deployment

Trend

after

deployment

Trend

difference p

Level

difference p

1508 4950 3442 0.001 35588 0.031

PMTCT related outcomes: improved early infant diagnosis testing

and syphilis testing


Trend

before

deployment

Trend

after

deployment

Trend

difference p

Level

difference p

Pregnant women

tested for syphilis -120 1229 1349 <0.0001 6640 0.001

Number of infants

receiving early infants

diagnosis testing by 2

months of age 1 67 65 <0.0001 -266 0.05


proportion of positive syphilis test results is now

very close to the syphilis prevalence estimated

from the 2010 ANC sentinel surveillance round

• Further optimization of maternal retention and EID testing coverage (plan to scale up POC EID testing)

• Support for large numbers of treatment experienced women

• Closing the other gaps (women who don’t receive prophylaxis, new infections amongst women during pregnancy and postpartum)

• Addressing other maternal health concerns (mental health)

What next?


The challenge with dolutegravir

• Malawi’s plan was to transition to Dolutegravir (DTG)- based ART regimens because of evidence that they are more potent, durable, convenient, better tolerated and have fewer drug interactions.

• Concern regarding safety of DTG-based ART regimens for use in early pregnancy.

What are we doing about dolutegravir (DTG)?


Malawi’s Plan

• Tenofovir/lamivudine/efavirenz will remain the standard 1st line for women who may get pregnant while on ART from 30kg+

• DTG-based ART regimens will be introduced for eligible patient groups from the beginning of 2019. ➢ Eligible groups: males from 30kg+ and women aged 45 years+ or with permanent

contraception

• Malawi created and successfully scaled up B+, a highly effective

PMTCT program

• Malawi has sustained B+ successes with excellent PMTCT and maternal

ART coverage, efforts to retain women and infants, and decreasing vertical

transmission moving close to elimination

• Malawi has also moved beyond B+, innovating and addressing other gaps

in PMTCT such as syphilis and EID testing coverage with interventions such

as its HDA program.

Conclusions


• Malawi seeks to continue to improve and grow, and much work remains

• Malawi Department of HIV & AIDS (DHA)• BIPAI network and leadership• Baylor Children’s Foundation Malawi• Technical Support to PEPFAR Programs in the

Southern African Region • Tingathe outreach program• USAID• PEPFAR• Spectrum Help Desk• Presentation technical guidance and support:

Elaine Abrams, Rose Nyirenda, Peter N. Kazembe, Stephen Chu, Katie Simon, ShaffiqEssajee, Saeed Ahmed

Acknowledgements10th annual International Workshop on HIV Pediatrics 2018 Session 3: PMTCT | July 21, 2018 | Steigenberger Hotel Amsterdam, the Netherlands

Documents

Updates on PMTCT from Malawi, the country where Option B+ ...regist2.virology-education.com/presentations/2018/10PED/41_Kim.pdf · Research and Implementation Director, Tingathe Program,