Enhanced ARV Monitoring in Countries: Brazil

Apresentação em tema: "Enhanced ARV Monitoring in Countries: Brazil"— Transcrição da apresentação:

1 Enhanced ARV Monitoring in Countries: Brazil
Adele Schwartz Benzaken Ministry of Health of Brazil Secretariat of Health Surveillance Department of STIs, HIV/AIDS and Viral Hepatitis Paris, July 23th 2017

2 No conflicts of interest to declare

3 Outline HIV/AIDS epidemic in Brazil New Brazilian guidelines
Economic impact Pharmacovigilance (Dolutegravir-containing regimen)

4 HIV/AIDS in Brazil July: Initiation of HIV notification.
SOURCE: MOH/SVS/Department of STIs, HIV/AIDS and Viral Hepatitis NOTE: (1) AIDS cases from Sinan e Siscel/Siclom until 30/06/2016 and SIM from 2000 to 2015. (2) HIV notified cases from Sinan until 30/06/2016.

5 HIV prevalence in Brazil
Source: (1) Veras et al. High HIV Prevalence among Men who have Sex with Men in a Time-Location Sampling Survey, SãoPaulo, Brazil. AIDS Behav Sep;19(9): ; (2) Bastos FI, Bertoni N. Pesquisa Nacional sobre o uso de crack: quem são os usuários de crack e/ou similares do Brasil? quantos são nas capitais brasileiras? Rio de Janeiro; p.; (3) Damacena GN, Szwarcwald CL, de Souza Júnior PR, Dourado I. Risk factors associated with HIV prevalence among female sex workers in 10 Brazilian cities. J Acquir Immune Defic Syndr Aug;57 Suppl 3:S144–52.; (4) Bastos, F. I. Taxas de infecção de HIV e sífilis e inventário de conhecimento, atitudes e práticas de risco relacionadas às infecções sexualmente transmissíveis entre usuários de drogas em 10 municípios brasileiros. Relatório técnico entregue ao Departamento de DST, Aids e Hepatites Virais, 2009.; (5) Kerr, L. Comportamento, atitudes, práticas e prevalência de HIV e sífilis entre homens que fazem sexo com homens (HSH) em 10 cidades brasileiras. Relatório técnico entregue ao Departamento de DST, AIDS e Hepatites Virais, 2009; e (6) Ms/SVS/DDAHV; (7) GRINSZTEJN B, et al. Unveiling of HIV dynamics among transgender women: a respondent-driven sampling in Rio de Janeiro, Brazil. The Lancet HIV, 3018(17) , fev, 2017.

6 Antirretroviral Therapy- Brazil, 2017
December 2013: ‘Treatment for All´ Source: Siclom/Department of STI, HIV/AIDS and Viral Hepatitis

7 Country level evidence/considerations that resulted in the DTG phase in
Sustainability Public Policies Costs in the long term New ARV National Budget

8 Country level evidence/considerations that resulted in the DTG phase in
Motivation for adopting an integrase strand transfer inhibitors (INSTIs) in first-line ART: Following the WHO protocol for Surveillance of HIV drug resistance in adults initiating antiretroviral therapy, we conducted a study covering all Brazilian geographical region. The overall transmitted drug resistance (TDR) prevalence in Brazil was 9.5% in 2015, reaching 11.2% in the Southeastern Brazil. The TDR for NNRTI the prevalence in Brazil was 5.62% (ranged from 4.5% in the Northeast and Central-West to 7.0% in the South).

9 Negotiation The incorporation of Dolutegravir did not affect the current MoH budget for the acquisition of ARV - R$ 1.1 billion (≈ US$ 300 million); Target audience: 83,000 for naive patients (>12 years old) and 17,000 for switch RAL to DTG in third line started in January 2017; Also to be used in post partum women, Hepatitis C coinfection together with DAA, post TB treatment, and PEP Protocol (under review).

10 Country level evidence/considerations that resulted in the DTG phase in
Expenditures according to ART regimen 2016 Current (2017) Initial ART USD 50,945,212.00 USD 117,659,475.14 ART after first regimen failure (NNRTI) USD 177,679,528.00 USD 162,086,543.00 ART after second regimen failure (PI/r) USD 80,781,964.86 USD 33,003,578.00 Other ART (TDF/3TC, Injectable AZT) USD 1,125,416.00 USD 1,125,416,00 Total USD ,86 USD 313,875,012.29

11 Changes in the ART regimen in Brazil
Scheme for starting treatment (Naïve): Preferential (highly active, high genetic barrier, less toxicity) Except TB+HIV and in pregnancy Alternatives Tenofovir + Lamivudina + Efavirenz (intolerance or contraindication to DTG) (contraindication to TDF in PLWH with negative test to HLA-B* 5701) Tenofovir + Lamivudine + Dolutegravir Abacavir + Lamivudine + Dolutegravir

12 Changes in the ART regimen in Brazil
From Raltegravir to Dolutegravir All patients on RAL need to switch to DTG (preferential INSTIs ) Lower cost, higher genetic barrier; non- inferiority, posology (1tab OD) PLWH will switch from Raltegravir to Dolutegravir in 2017 Exceptions for RAL maintenance Rescue regimen containing ETV, without PI/r Anticonvulsant use (phenytoin, phenobarbital, oxicarbamazepine and carbamazepine), with no possibility for changes Dofetilide use

13 Changes in the ART regimen in Brazil – Protease Inhibitors
Failure first regimen Guide by genotyping test Preferential: Atazanavir/Ritonavir Alternative: Darunavir/Ritonavir Atazanavir : To be the preferential IP Darunavir For those in 3rd line or ATV intolerance Lopinavir: -July 2017: started switched to ATV (or DRV): 78,000 PLWH (except special cases in TB and Hepatitis C treatment) Source: Information Note nº 007/2017-DIAHV/SVS/MoH; Information Note nº059/2017-DIAHV/SVS/MoH .

14 Pharmacovigilance (Dolutegravir-containing regimen)
From the second DTG dispensation, a questionnaire is offered to the doctors and pharmacists, so they can report possible adverse events related with DTG use; Pilot study: From April to June 2017; 10 ‘ARV Dispensations Units’ with the largest number of new patients enrolled in treatment in the last 12 months in the 5 Brazilian geographical region; Monthly monitoring.

15 PHARMACOVIGILANCE QUESTIONNAIRE (Medicines Logistics Control System - SICLOM)

16 Pharmacovigilance - DTG
DTG users- from January to June 2017 By 30th June, 2017: a total of 3,086 questionnaires filled A total of 39,990 patients on DTG 22,683 patients started ART with DTG 17,307 patients switched from RAL to DTG

17 Pharmacovigilance – DTG Main preliminary results (30th June, 2017)
N. PLWHIV (N)

18 Final remarks The Brazilian Ministry of Health choose for a nationwide implementation of Dolutegravir in first-line ART instead of a staggered one, respecting the principles of universality, integrality and equity of the Public Brazilian Unified Health System. Differentiated treatment regimen allows a more personalized care for PLWH and it was received in a very positive way by medical professionals. No important issues regarding adherence registered. The pharmacovigilance study for DTG, since 5th July, was implemented in partnership with Brazilian Health Regulatory Agency (ANVISA) for all 840 ‘ARV Dispensations Units’ in the country.

19 http://www. worldhepatitissummit
#HepSummit2017 We hope to see yours countries represented there!

20 242 Acknowledges DEPARTMENT OF STI/HIV/AIDS AND VIRAL HEPATITIS
BRAZILIAN MINISTRY OF HEALTH ALINE CRISTINA VIEIRA, CÍNTIA CLARA GUIMARÃES DA SILVA, INOCÊNCIA MARIA NEGRÃO, IVO BRITO, JULIANA UESONO, LEONARDO DE ALMEIDA, MANOEL CARLOS BRAGA, MARIA ALICE TIRONI, MAURITÂNIA PEREIRA, SANDRA REGINA MIGUEL, SARA ALVES NEVES, THAISA GOIS LIMA, ALEXSANA SPOSITO, ANA FRANCISCA KOLLING, ESDRAS DANIEL PEREIRA, FERNANDA FONSECA, FERNANDA RICK, FILIPE PERINI, FRANCISCA LIDIANE FREITAS, GÉSSICA NAIARA RIBEIRO, GLAUCIO MOSIMANN, ITANA DOS SANTOS, JOÃO GERALDO NETTO, LEONARDO GALENO, MARIHÁ DE MOURA, REGINA BRIZOLARA, ROBÉRIO CARNEIRO JÚNIOR, TATIANNA DE ALENCAR, ADEMILDO COELHO MENDES, AEDÊ CADAXA , ALEXANDRE MAGNO, ANGELA GASPERIN MARTINAZZO , EDISON BARBOSA DOS SANTOS , ELAINE DA CUNHA RAMOS , FERNANDA DIAS ALMEIDA MIZAEL , LETICIA ALVES BORGES , LOURIVALDO ALVES PONTEDURA , LUANA DA SILVA CARVALHO , LUCIANO DEMETRIUS LEITE , MARCOS CLEUTON DE OLIVEIRA , MARIA ÉRICA BRITO DOS SANTOS , MARY GRACE FIGHIERA PERPÉTUO , MILENA BENDICHO , NAGILA RODRIGUES PAIVA , RENATO DE OLIVEIRA FERNANDES , SALETE SAIONARA BARBOSA , CLARISSA HABCKOST DUTRA DE BARROS , FABIO DA SILVA SARTORI , JOSI ANNE PAZ E PAZ , JULIANA MACHADO GIVISIEZ , FÁVERO CLEMENTE , SILVIA GIUGLIANI , TAINAH DOURADO LOBO, LILIAN VIVIANE MELO DA SILVA RAMOS , MAURO TEIXEIRA DE FIGUEIREDO , MICHELE DANTAS, NEIDINA PEREIRA DA SILVA , CLAUDIA MARIA MEDEIROS , IÊDA MARIA OLIVEIRA FORNAZIER , RENATO GIRADE CORREA , CRISTINA ALVES CANDIDO , LEONARDO MITSURU TANABE , LUCIO DA COSTA SOUSA , MARCIA DE OLIVEIRA UCHOA , MARIELLE RODRIGUES DA CUNHA CASTRO PROBST , PATRICIA LAIS SOARES , SCHEILLA OLIVEIRA, MIGUEL , JOSE ANTONIO GONÇALVES , MAURICIO BARROSO JÚNIOR , MONISE ALMEIDA SILVA , WALQUIRIA TORRES MALHEIROS , FABIO OBRIEN DE CARVALHO , JOSIANY SOUSA DE CARVALHO RICARDO LUIZ DE FREITAS , ALEXANDRA PRISCILLA DE PAULA SOARES , ALICE REGINA DUARTE , AUGUSTO BERNARDES SOUSA , CLEBER ELIAS DE SOUZA , GLAUCIO ANTONIO DOS SANTOS , EDILSON SIMPLICIO DE SOUSA , JANE SOUZA MARQUES , REJANE DOS SANTOS LEVY , CLAUDIA CARDOSO LIMA , FLAVIA CRISTINA BARROS , LILIAN GOMES GONÇALVES FERNANDES , MARTA REGINA DA SILVA LIMA , NATALIA GOMES PINHEIRO , PEDRO NAHUEL MENDEZ , ANDRÉA SALOMÃO , ANDREIA PAULA ZARAT TAVARES , CAROLINE SIQUEIRA , DILMA SOUSA , ELISABETE LIMA DE JESUS , ISABELLA CRISTINE DA SILVA , KRYGIDO HENRIQUE PASSETTO , LIGIA BRAUN , MARCOS DE FREITAS GUIMARÃES , MARIA CHRISTINA PEIXOTO PACHECO , MARIA DE JESUS SOARES DE SOUSA , VANESSA FAUSTINO , CAMILA MARCIA MENDES, ANA JULIA FERNANDES DE SIQUEIRA , FERNANDA MOURA FERREIRA , RAISA DIB FARIA NEVES , GETULIO DE CASTRO SOBRINHO , IZA KELEN OLIVEIRA FORNAZIER , MARCOS JOSÉ DA SILVA , MARIA KAROLYNA ALVES DA SILVA , ANA CRISTINA E SILVA AGUIAR , ANA LUIZA NUNES , ANDERSON SANTANA ROSA , ANDRÉ MACEDO SANTOS , ANTONIO RAMOS DE CARVALHO , ATHUS CORRÊA FERNANDES , CLEBER RICARDO PINHEIRO COTRIM , CRISTINA AVELLAR ALMEIDA , FELIPY TAVARES AMORIM , FERNANDO JUNIOR CUSTÓDIO , GUILHERME HEIDMANN , ITAMAR AGUIAR , DENISE AGUIAR DE MORAES , EDUARDO CARDOSO DE AMORIM , EMANUEL DE MELO FILHO , JEAN CLAUDIO SANTOS , JOSÉ EDGARD JÚNIOR , LARISSA OLIVEIRA DE SÁ , LAUDEMIRO BEZERRA, LUIS EDUARDO DA SILVA , LUIZ HENRIQUE MORAIS , MARCO AURELIO IVAN DE OLIVEIRA , MUHAMMAD ZAKARIA DANDASH , PAULO RODRIGO DE OLIVEIRA , PRISCILA TEODORA NASCIMENTO , REGINALDO FREIRE GOMES , RENATTO FERREIRA CARRIJO , ROBERTO FARIAS LIMA , ROBERTO FRAZINO , ODRIGO FERNANDES , WANDERSON GONTIJO , BARBARA GRANER BARBOSA , ELISA ARGIA CATTAPAN , ELTON CARLOS DE ALMEIDA , JOSÉ NILTON NERIS GOMES , MARIA CASSIA JACINTHO MENDES CORREA , MELINA ÉRICA SANTOS , NEIDE FERNANDES DE SOUZA , SIMONE MONZANI VIVALDINI , VALQUÍRIA SOUZA CHRISOSTOMO , ALESSANDRO RICARDO CARUSO DA CUNHA , CLAUDIA SOUSA , DAIANA MARIAN DRESCH , FLÁVIA KELLI ALVARENGA PINTO , FLÁVIA MORENO ALVES DE SOUZA , GERSON FERNANDO MENDES PEREIRA , LUCIANA FETTER BERTOLUCCI TANIGUCHI , RACHEL RIBEIRO , ARIA CRISTINA PIMENTA DE OLIVEIRA , SILVANA PEREIRA GIOZZA , THAÍS SILVA ALMEIDA DE OLIVEIRA , ANDRESA NOLASCO GOMES PEIXOTO ,ARAKEN ALPINO RODRIGUES , GRAZIELA DE QUEIROZ MACEDO , LAÍS SILVA GARCIA , ANA FLAVIA PIRES, CRISTIANE VIEIRA FERREIRA , DANIELA CRISTINA SOARES , DANIELE VAN-LUME SIMÕES ,IGOR KOHIYAMA , JOSÉ BOULLOSA NETO , MARIANA VILLARES MARTINS , NAZLE MENDONÇA COLLAÇO VÉRAS , PÂMELA CRISTINA GASPAR , REGINA APARECIDA COMPARINI , ROBERTA BARBOSA FRANCISCO , ROSANA ELISA GONÇALVES MELO , ALEX COSTA ALMEIDA , ANTONI FLAVIO FURTADO SCARTEZINI , CYNTHIA JULIA BRAGA BATISTA , EDUARDO MALHEIROS, JESSIKA ARRUDA DA SILVA , KARIM MIDORI SAKITA , LARISSA MEIRA PASSAMANI , MIRIAM DE ARAUJO , NIVEA OREM DE OLIVEIRA GUEDES , PATRICIA CRISTINA LOPES CORRÊA , PAULO ROBERTO JOBIM DUTRA ROGÉRIO DOS SANTOS LIMA , ROGGER DIQUIQUE , RONALDO JORGE FEITOZA , THAIS CARDOSO RODRIGUES MORAIS , VICTORIA RAFAELA MUNIZ DOS SANTOS , ANA ROBERTA PATI PASCOM , DENISE DE CARVALHO , FERNANDA BORGES MAGALHÃES , MAÍRA TAQUES DOS SANTOS CHRIST , MARIANA JORGE DE QUEIROZ , MARIANA VELOSO MEIRELES , RAFAELA MENDES MEDEIROS , ALÍCIA KÜGER , ANA MÔNICA DE MELLO , CARINA BERNARDES SOUSA , DAMIANA DE OLIVEIRA, DIEGO AGOSTINHO CALIXTO , ELISIANE NELCINA PASINI , GILVANE CASIMIRO DA SILVA , IRENE SMIDT VALDERRAMA , PAULA ADAMY , IVANETE RIBEIRO DE CARVALHO , LILIANA PITTALUGA MARCIA REJANE COLOMBO , MARIA VITORIA RAMOS GONÇALVES , RODRIGO FÁVERO CLEMENTE , SILVIA GIUGLIANI , TAINAH DOURADO DE MIRANDA LOBO .

21 Thank you www.aids.gov.br adele.benzaken@aids.gov.br