13th International workshop on co-infection

HIV & Hepatitis

23 June 2017

Lisbon - Portugal

Authors: Sarmento – Castro R., Marques M., Tavares A., Gonçalves C, Furtado I.,

R. de Valdoleiros S., Vasconcelos O., Seabra J., Méndez J.

New direct antiviral agents (DAAs) are safe and effective in the treatment of

patients with hepatitis C infection.

Few clinical trials included a significant number of cirrhotic co-infected

patients.

In this study, we evaluate the efficacy and safety of DAAs in the treatment of

cirrhotic HCV/HIV co-infected patients in a real life setting.

Prospective study of cirrhotic (TE ≥ 12.5 kPa) HCV/HIV

co-infected patients under HAART

113 patients initiated treatment with DAAs for

12 or 24 weeks

We compared the baseline and SVR12 characteristics

Possible factors associated with SVR12 were

analysed

93,8%

3,5% 2,7% Risk factor

IDU

Sexual

Unknown

Characteristics Value

Mean age 47 years old

Male sex 98 (86.7%)

HIV infection Mean

CD4+/mm3

count

577

Viral load

< 20 cp/ml

107

(95%)

Characteristics Value

Treatment experienced

38 (33.6%)

Transient elastrography (TE)

12.5 -25 kPa

≥ 25 kPa

70 (61,9%)

43 (38.1%)

Endoscopic signs of portal hipertension 22 (19.5%)

MELD mean score 8,7

Child pugh score A 112 (99.1%)

Platelets/µL

< 75 x 103

≥ 75 x 103

19 (16.8%)

94 (83.2%)

Albumin (g/dl)

< 3.5

≥3.5

10 (8.9%)

103 (91.1%)

77%

0,90%

12,40%

9,70%

G1 G2 G3 G4

Mean HCV RNA –

3.835.653 UI/ml

SOF/LDV

SOF/LDV + RBV

SOF + RBV

PEG IFN + RBV+ SOF

SOF/DCV + RBV

3 D´S

SOF+ DCV

50,4%

34,0%

5,3%

3,5%

2,7%

2,7%

1,8%

Without statistically significant differences

[VALOR]%

[VALOR]%

[VALOR]%

[VALOR]%

G1 G2 G3 G4

[VALOR]%

[VALOR]%

Naive Treatmentexperienced

[VALO

R]%

Global

106

113 71

75

35

38

83

87

1

1 12

14

10

11

Albumin

(g/dl)

SVR 12 (% and N)

No Yes

< 3,5 3,6% (4) 5,4% (6)

≥ 3,5 2,7% (3) 88,5% (100)

Total 7 106

Albumin < 3,5 g/dl was

associated with poor SVR12

(p=0.007)

4,32 4,33

4,41

4,45

4,5

Baseline W4 EOT PT4W SVR12

Statiscally significant improvement (p < 0.05)

129.000

145.000

153.214

143950 142405

Baseline W4 EOT PT4W SVR12

Albumin Platelets MELD score

baseline: 8,7

PTW12: 6,2

25,8

21,8 19,1

Baseline EOT SVR12

Statiscally

significant decrease

(p < 0.05)

Five patients decompensated

- Two with encephalopaty

- Two developed hepatocellular carcinoma

- One had variceal bleeding

Patient Genotype IL 28B

Baseline Previous

HCV

treatment

DAAs

combination Outcome

Albumin

(mg/dl)

Child-

Pugh

Score

MELD

score

HCV RNA

(UI/mL)

TE

(KPa)

Platelets

(x103/ ul)

1 1 Unkno

wn 5,14 A

8 4.970.000 26,6

155 Yes

SOF/LDV //

24w Relapse

2 1 Unkno

wn 4,5 A

7

2.400.000 17,6

162

No SOF/LDV //

24w

Lost to

follow up

3 4 Unkno

wn 2,34 A

12

7.190.000 51,4

141

Yes SOF/LDV+RBV

// 24w

Lost to

follow up

Patient Genotype IL

28B

Baseline

Previous

HCV

treatment

DAAs

combination Outcome

Albumin

(mg/dl)

Child-

Pugh

Score

MELD

score HCV RNA

(UI/mL)

TE

(KPa)

Platelets

(x103/ ul)

4 1 CC 3,6 B

11 22500 49,7

119 Yes

SOF/LDV+RBV

// 24w

Died

(encephal

opathy)

5 1 CT 3,5 A 7

6.100.000 15,3 227 No SOF/LDV+RBV

// 12w

Died

(AMI)

6 3 CC 3,30 A 10

1.370.000 36 102 No SOF/LDV + RBV

// 24w

Died

(HCC)

7 3 CT 3,37 A

11 153.000 47,2 61 No SOF/DCV // 24w

Died

(Acute GI

bleeding)

SVR was achived in 93.8% of HCV/HIV cirrhotic patients.

Liver function had a significant improvement during the

treatment with DAAs (MELD score, liver fibrosis, platelets

and albumin).

Lower level of albumin was significantly associated with

poor SVR 12.

Rui Sarmento e Castro

Josefina Méndez

Ana Horta

Ana Paula Tavares

João Seabra

Olga Vasconcelos

Miguel Araújo

Maria João Gonçalves

Celina Gonçalves

Isabel Furtado

Cristina Soeiro

Maria José Santos

13th International workshop on co-infection

HIV & Hepatitis

23 June 2017

Lisbon - Portugal