SEROCLEARANCE OFHBSAG IN CHRONIC HEPATITIS …regist2.virology-education.com/presentations/2017/HEPDART/63_Ono.pdf · seroclearance ofhbsag in chronic hepatitis b virus patients onlamivudine,

SEROCLEARANCE OF HBSAG IN CHRONIC HEPATITIS B VIRUS

PATIENTS ON LAMIVUDINE, TENOFOVIR OR ENTECAVIR THERAPY:

A 10 YEARS EXPERIENCE.

Felipe Pereira de Souza, Mariana Akemi Nabeshima, Luís Cláudio Alfaia Mendes, Denise Cerqueira Paranaguá-

Vezozzo, Rodrigo Martins Abreu, Flair José Carrilho, Suzane Kioko Ono

Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology

University of São Paulo School of Medicine, São Paulo, Brazil;

HEP DART 2017ABSTRACT NUMBER: 13

December 6th 2017

BACKGROUND

In Brazil, HBV antivirals are given by government (SUS – Unique/Universal

Health System). Universal access to every citizen who needs treatment

HBsAg loss, with or without anti-HBs seroconversion, is an optimal endpoint,

as it indicates profound suppression of HBV replication and viral protein

expression

Long term HBsAg seroclearence frequency with nucleos(t)ide analogs (NUC)

treatment is still not well established in Brazil

Ministerio da Saude – PCDT HBV 2017AASLD, EASL, APASL HBV Guidelines 2017

AIMS

□ This study aimed to investigate the efficacy on HBsAg clearance of

Lamivudine, Entecavir and Tenofovir in a cohort of chronic hepatitis B

patients.

CASUISTIC AND METHODS

□ Retrospective descriptive study;

□ 156 new patients treated with Lamivudine (150mg/day), Entecavir(0.5 mg/day), Tenofovir (300 mg/day) or combinations;

□ Patients followed up in the A2MG404 ambulatory (Hospital dasClínicas, São Paulo, Brazil) between January 1st 2005 and December31th 2015.

CASUISTIC AND METHODS

□ Demographic, epidemiological and clinical data were obtained frominstitutional electronic medical records (SIGH-PRODESP, HCMED andProntMed);

□ Data collection and management – REDCap (V6.16.4);

□ Statistical analysis – R software (V3.3.0).

□ Patients selection algorithm andeligibility criteria:

STUDY POPULATION (N=156)

LAMIVUDINE 150 mg(n=30)

TENOFOVIR 300 mg(n= 47)

ENTECAVIR 0.5 mg (n= 29)

COMBINED THERAPY

(n= 50)LAM +TDF (n= 35)LAM + ADF (n= 5)ENT + TDF (n=8)ENT + ADF (n=2)

□ Sub-groups division:

RESULTS

‘

Baseline characteristics of patients

‘

‘

RESULTS

Baseline characteristics of patients

‘

Prevalence of HCV and HIV infections in patients infected with HBV

HBV+HCV HBV+HIV HBV+HCV+HIV

5(3.20%)

3(1.92%)

1(0.64%)

‘

Patient’s country of birth

‘Brazil China Poland Cameroon Not declared

151(96.79%)

2(1.28%)

1(0.64%)

1(0.64%)

1(0.64%)

Population schooling level

Primary educationcompleted

Incompleteprimary education

High schoolcompleted

Undergraduatecompleted

Incomplete highschool

Illiterate Incompleteundergraduate

Not declared

54(34.61%)

33(21.15%) 31

(19.87%)

13(8.33%)

8(5.13%) 5

(3.20%)5

(3.20%)

7(4.49%)

‘

HBsAg and HBeAg loss rates according to treatment

‘

‘

Therapeutic scheme: Lamivudine + Tenofovir

LAM or LAM combo 7/70 (10%) HBsAg loss (n.s.)

LAM resistance 40/70 (57%)

Comparison between the final parameters of patients with HBV treated with Lamivudine, Tenofovir or Entecavir

‘

‘

lossloss

lossloss

LAM or LAM combo 7/70 (10%) HBsAg loss (n.s.)

Treatment SEX AGE AgHBe Cirrhosis ANTIHBS

LAM FEMALE 73 NEG Yes NR < 2 IU/ML

LAM MALE 55 POS No NR < 2 IU/ML

LAM MALE 59 NEG Yes R 28.81 IU/ML

LAM MALE 50 NEG Yes R 706 IU/ML

LAM MALE 70 NEG Yes R 469.6 IU/ML

LAM +TDF FEMALE 66 POS No R >1000 IU/ML

LAM +TDF MALE 50 POS Yes R 41.13 IU/ML

TDF FEMALE 59 POS No NR < 2 IU/ML

TDF MALE 62 POS Yes NR < 2 IU/ML

HBsAg seroconversion

CONCLUSIONS

□ Long term viral suppression with nucleoside analogues leads to HBsAg loss

and cure may be well within reach with oral antivirals.

□ When resistance to lamivudine is not present HBsAg loss is possible

□ It is of note that the dose of lamivudine (150 mg) used in this study is higher

than the dose used outside Brazil.

Time to hit HIV (HBV) early and hard

David Ho, NEJM 1995

Thank you!

Felipe Pereira de Souza Luiz Cláudio A Mendes Rodrigo Martins Abreu Julia PiresNAYARA LOPES LUCENA Daniel Nakagawa Vera Kim Ramon Bispo

Cassiana Alves Mariana Nabeshima Denise RodriguesVictor Van Vaisberg

Residents Gastroenterologia Clínica Maria Cleusa Martins GoesResidents Assistência Farmacêutica Denise Paranagua-Vezozzo

Flair José Carrilho