SEROCLEARANCE OF HBSAG IN CHRONIC HEPATITIS B VIRUS PATIENTS ON LAMIVUDINE, TENOFOVIR OR ENTECAVIR THERAPY: A 10 YEARS EXPERIENCE.

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1 HEP DART 2017 ABSTRACT NUMBER: 13 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; December 6 th 2017

2 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 2017 AASLD, EASL, APASL HBV Guidelines 2017

3 AIMS This study aimed to investigate the efficacy on HBsAg clearance of Lamivudine, Entecavir and Tenofovir in a cohort of chronic hepatitis B patients.

4 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 das Clínicas, São Paulo, Brazil) between January 1 st 2005 and December 31 th 2015.

5 CASUISTIC AND METHODS Demographic, epidemiological and clinical data were obtained from institutional electronic medical records (SIGH-PRODESP, HCMED and ProntMed); Data collection and management REDCap (V6.16.4); Statistical analysis R software (V3.3.0).

6 Patients selection algorithm and eligibility criteria:

7 Sub-groups division: 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)

8 RESULTS Baseline characteristics of patients

9 RESULTS Baseline characteristics of patients

10 Prevalence of HCV and HIV infections in patients infected with HBV 5 (3.20%) 3 (1.92%) 1 (0.64%) HBV+HCV HBV+HIV HBV+HCV+HIV

11 Patient s country of birth 151 (96.79%) 2 (1.28%) 1 (0.64%) 1 (0.64%) 1 (0.64%) Brazil China Poland Cameroon Not declared

12 Population schooling level 54 (34.61%) 33 (21.15%) 31 (19.87%) 13 (8.33%) 8 (5.13%) 5 (3.20%) 5 (3.20%) 7 (4.49%) Primary education completed Incomplete primary education High school completed Undergraduate completed Incomplete high school Illiterate Incomplete undergraduate Not declared

13 HBsAg and HBeAg loss rates according to treatment LAM or LAM combo 7/70 (10%) HBsAg loss (n.s.) LAM resistance 40/70 (57%) Therapeutic scheme: Lamivudine + Tenofovir

14 Comparison between the final parameters of patients with HBV treated with Lamivudine, Tenofovir or Entecavir loss loss loss loss LAM or LAM combo 7/70 (10%) HBsAg loss (n.s.)

15 HBsAg seroconversion 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 IU/ML LAM MALE 50 NEG Yes R 706 IU/ML LAM MALE 70 NEG Yes R IU/ML LAM +TDF FEMALE 66 POS No R >1000 IU/ML LAM +TDF MALE 50 POS Yes R IU/ML TDF FEMALE 59 POS No NR < 2 IU/ML TDF MALE 62 POS Yes NR < 2 IU/ML

16 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

17 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

18 Thank you! Felipe Pereira de Souza Luiz Cláudio A Mendes Rodrigo Martins Abreu Julia Pires NAYARA LOPES LUCENA Daniel Nakagawa Vera Kim Ramon Bispo Cassiana Alves Mariana Nabeshima Denise Rodrigues Victor Van Vaisberg Residents Gastroenterologia Clínica Residents Assistência Farmacêutica Maria Cleusa Martins Goes Denise Paranagua-Vezozzo Flair José Carrilho