HIV and Viral Hepatitis Local Situation in Puerto Rico

Epidemiology and Treatment

Jorge L Santana MD;FIDSA

Professor Medicine &Infectious Diseases

University Puerto Rico

School of Medicine

Disclosures

Disclosure of speaker’s interests

Relations that could be relevant to the

meetingCompany names

• Investigator initiated study grants,

speaker fees and honoraria

Gilead Sciences

ViiV Healthcare

AbbVie

Janssen

Merck Sharp & Dhome

Outline

• HIV Burden

• Hepatits B (limited data)

• Hepatitis C Stats, incidence , prevalence

Pilot Project mono and co infected treatment experience

• Polaris Observatory 2015-2030 Estimates

• Conclusions

HIV IN PUERTO RICO, 1980 – 2018*

0

2500

5000

7500

10000

12500

15000

17500

20000

0

500

1000

1500

2000

2500

3000

3500

Pre

va

len

ce o

f H

IV n

ot

AID

S, A

IDS

Ne

w H

IV d

iag

no

ses,

De

ath

s

Year

AIDS prevalence HIV not AIDS prevalence HIV not AIDS diagnoses49,424

Reported cases of HIV infection

(including AIDS)

1980-2018

29,176Number of deaths reported among PLWH by December

2018

677Number of children (0 - 12)

diagnosed with HIV infection1981 - 2018

18,360Number of people residing in

Puerto Rico by December 2018

Source: HIV/AIDS Surveillance System, Epidemiology Division, Puerto Rico Department of HealthNota: Data include persons diagnosed with HIV infection reported in Puerto Rico by December 2018.

Rates of Adults and Adolescents Living with Diagnosed HIV Infection, by Area of Residence, Year-end 2016—United States and 6 Dependent Areas

N = 1,006,691 Total Rate: 367.6

Rates of Diagnoses of HIV Infection among Adults and Adolescents, by Area of Residence, 2017 — United States and 6 Dependent Areas

N = 38,640 Total Rate: 14.0

Stage 3 (AIDS) Classifications among Adults and Adolescents with HIV Infection, by Area of Residence, Cumulative through 2017—United States and 6 Dependent

AreasN = 1,281,787

12th placeHIV diagnoses rates among adults and adolescents ≥13 years

in 2017 (15.4 per 100,000 population)

6th placeadults and adolescents living with diagnosed HIV infection in

2016 (572.6 per 100,000 population)

10th placehighest number of cumulative AIDS cases in 2017

According to the latest CDC report, Puerto Rico is one of the top ten states/territories with the highest

number of cumulative AIDS cases, and HIV prevalence.

HIV DIAGNOSES, PREVALENCE, AND CUMULATIVE AIDS CASES, BY AREA OF

RESIDENCE -UNITED STATES AND 6 DEPENDENT AREAS

Fuente: Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published November 2018. Accessed [11-15-2018].

ENDING THE HIV EPIDEMIC: A PLAN FOR AMERICA

Geography

New HIV diagnoses

2016-2017

Los Angeles County, CA 3,470Miami-Dade County, FL 2,427Harris County, TX 2,358

Cook County, IL 1,996

Dallas County, TX 1,659

Broward County, FL 1,416

Kings County, NY 1,220

Fulton County, GA 1,174

Maricopa County, AZ 1,048

Bronx County, NY 1,013

Puerto Rico 979Philadelphia County, PA 965Orange County, FL 934San Diego County, CA 907

Clark County, NV 902

Queens County, NY 898

New York County, NY 846

Bexar County, TX 723

Dekalb County, GA 689

Wayne County, MI 659

District of Columbia, DC 659

Orange County, CA 652

Hillsborough County, FL 622

Palm Beach County, FL 603Essex County, NJ 596Tarrant County, TX 592Duval County, FL 584

Riverside County, CA 574

Prince George's County, MD 563

Mecklenburg County, NC 534

San Francisco County, CA 513

Shelby County, TN 504

Alameda County, CA 475

Travis County, TX 465

Baltimore City, MD 464

Franklin County, OH 440

Orleans Parish, LA 435

King County, WA 434

San Bernardino County, CA 430

Marion County, IN 426

Montgomery County, MD 368

Cuyahoga County, OH 353

East Baton Rouge Parish, LA 352

Pinellas County, FL 335

Hamilton County, OH 330

Cobb County, GA 324

Hudson County, NJ 322

Sacramento County, CA 321

Suffolk County, MA 320

Gwinnett County, GA 312

Nearly a thousand cases of HIV infection were diagnosed during the 2016-2017 period in Puerto Rico.

Source: Centers for Disease Control and Prevention. Ending the HIV epidemic: A Plan For America http://www.hiv.gov. Published February 2019. Accessed [04/24/2019].

HEPATITIS BSituation in PR

Hepatitis B

• Very little data was available from the Dept. of Health in terms of Stats, incidence or prevalence

• Mandatory vaccination since the early 90`s make it very rare disease (85% compliance but in the last decade it has dropped to 77%)

• In 2015 29 cases of (acute) hepatitis B , 2016 – 17 cases, 2017 - 12 cases and in 2018 – 6 cases.

• All case were within 30-70 age group, no infants or adolescents

• Ref: WHO Health Guidance Report in the Americas 2016-17

• Dept of Health last minute data ; search may include suspecte or “no case”

HEPATITIS C Situation in PR

Epidemiology of Hepatitis C Puerto Rico

10

1. Kershenobich D, et al. Liver Int 2011;31 Suppl 2:18-29; 2. Perez CM, et al. BMC Infect Dis 2010;10:76;

3. Rodriguez-Perez F, et al. P R Health Sci J 2004;23:49–56; 4. Reyes JC, et al. J Urban Health

2006;83:1105-13.

Prevalence somewhat controversial; Reports : Puerto Rico 2.3%; San Juan 6.3% (dating back 8-14 years)

• Genotype Distribution: G1 (75-80%), G2 (12.1%), G3 (3.8%) y G4 (2%)

• Prevalence significantly higher in male (4.0%) female (1.0%)

• Prevalence of the infection PWID: 60-85%

• Isolated report in a sample in 2004: approximately 89,500 individuals with positive Ab for Hep. C

Estimated Viremia in the AMERICAS

Hepatitis B and C in the Spotlight. A public health response in the Americas, 2016. Washington, D.C. : PAHO; 2016

Surveillance System Reporting of Hepatitis C

in Puerto Rico: 2010 - 2015

Prevalence cases reported Hepatitis C to SurveillanceSystem per age group Puerto Rico, 2010-2015

Grupo de edad

Casos reportados

(sospechosos y

confirmados)

Prevalencia

(%)**

0-9 136 0.03

10-19 123 0.02

20-29 901 0.18

30-39 1,961 0.42

40-49 2,594 0.54

50-59 3,055 0.66

60+ 2,564 0.32

Total 11,334 0.31

**Se utilizó la población estimada para el año 2012 (población a mitad del periodo).

Nota: Incluye casos sospechosos y confirmados

Number of cases for Hepatitis C reported to theSurveillance System per year in males and females

Puerto Rico, 2010-2015

1451 1504

827

1588

2031

828

522 602

332

585735

329

0

500

1000

1500

2000

2500

2010 2011 2012 2013 2014 2015**

Cas

os

rep

ort

ado

s

Año de reporte

Hombres Mujeres

Notas: Incluye casos sospechosos y confirmados Tasa hombre a mujer proporción 3:1

**Aún faltan casos por ser registrados en éste periodo

Number of cases for Hepatitis C reported to the SurveillanceSystem per year of report and age group Puerto Rico, 2010-

2015

0

200

400

600

800

1000

2010 2011 2012 2013 2014 2015**

Cas

os

rep

ort

ado

s

Año de reporte

0-9 10-19 20-29 30-39 40-49 50-59 60+

Notas: Incluye casos sospechosos y confirmados.

**Aún faltan casos por ser registrados en éste periodo.

Fiscal Planning Board (Economic Disaster)

Irma– MARIA (Natural Disaster)

Governor Forced Resignation (Political Disaster)

But then…The Disastrous 2016-2017,2019

Nightmare Began

Preliminary Report Dept. Health Hep. C PR 2017Suspicious, confirmed Ab

Personas reportadas con Hepatitis C en Puerto Rico, 2017

Sexo Número de casos Porciento

Hombres 911 72.50

Mujeres 333 26.50

Desconocido 12 1.00

Total 1,256 100.0

Grupo de edad Número de casos Porciento

0 - 14 12 0.96

15 - 19 7 0.56

20 - 24 22 1.75

25 - 29 29 2.31

30 - 34 51 4.06

35 - 39 113 9.00

40 - 44 117 9.32

45 - 49 136 10.83

50 - 54 200 15.92

55 - 59 181 14.41

60 - 64 151 12.02

>=65 222 17.68

Desconocido 15 1.19

Total 1,256 100.00

Región de salud Número de casos Porciento

Aguadilla 45 3.58

Arecibo 72 5.73

Bayamón 216 17.20

Caguas 195 15.53

Fajardo 63 5.02

Mayagüez 59 4.70

Metropolitana 295 23.49

Ponce 175 13.93

Desconocido 136 10.83

Total 1,256 100.00

Preliminary Report Dept. Health Hep. C 2017

Sexo Número de casos Porciento

Hombres 911 72.50

Mujeres 333 26.50

Desconocido 12 1.00

Total 1,256 100.0

Grupo de edad Número de casos Porciento

0 - 14 12 0.96

15 - 19 7 0.56

20 - 24 22 1.75

25 - 29 29 2.31

30 - 34 51 4.06

35 - 39 113 9.00

40 - 44 117 9.32

45 - 49 136 10.83

50 - 54 200 15.92

55 - 59 181 14.41

60 - 64 151 12.02

>=65 222 17.68

Desconocido 15 1.19

Total 1,256 100.00

Health Regions Number of cases %

Aguadilla 45 3.58

Arecibo 72 5.73

Bayamón 216 17.20

Caguas 195 15.53

Fajardo 63 5.02

Mayagüez 59 4.70

Metropolitana 295 23.49

Ponce 175 13.93

Desconocido 136 10.83

Total 1,256 100.00

Personas reportadas con Hepatitis C en Puerto Rico, 2017

Efforts 2 do something 2014-2015

• Expert panel appointed by Secretary of Health

• Establishment of national guidelines on management and treatment

• AASLD /IDSA guidance template utilized

• Pilot project started with 3 centers within the Immunology clinics both for mono as well as co infected individuals (San Juan, Ponce, Mayaguez)

• Bi-annual meetings to revise criteria, functions and performance requirements within the Pilot program

• In 2016 treatment criteria are expanded to include F1-F2 stages and the number of sites is increased to 5

Pilot Protocol Hepatitis C Mono-Infected Patients

CPTETS

Fiscal Situation 2015-16

PERFIL DE LOS CASOS MONO-INFECTADOS HC EN TRATAMIENTO Y QUE TERMINARON TRATAMIENTO AL 3 DE NOVIEMRE DE 2017

(n=40), PROYECTO PILOTO DE MANEJO Y TRATAMIENTO DE HEPATITIS C

SEXO

MUJERES (%) 1 (26%)

HOMBRE (%) 28 (74%)

EDAD (ANOS)

RANGO 38 - 73

PROMEDIO 54

REGIONES Y/O CENTROS CLINICOS ATORIZADOS (CCA) DONDE RECIBEN O RECIBIERON TRATAMIENTO

CPTET PONCE 12 (53%)

CPTET MAYAGEZ 11 (29%)

CPTET SAN JUAN 7 (18%)

GENOTIPOS TRATADOS

GENOTIPO 1 33 (81%)

GENOTIPO 2 01 (3%)

GENOTIPO 3 05 (13%)

GENOTIPO 4 01 (3%)

PORCENTAJE DE FALLOS VIROLOGICOS DOCUMENTADOS AL MOMENTO 00 (0%)

DAA AVAILABLE AT PUERTO RICO DRUG FORMULARY INCLUDING ADAP

SOFOSBUVIR

LEDIPASVIR/SOFOSBUVIR

ELBASVIR/GRAZOPAVIR

DACLATASVIR

DASABUVIR/OMBITASVIR/

PARITAPREVIR/RITONAVIR

SOFOSBUVIR/VELPATASVIR

GLECAPREVIR/PIBRENTASVIRSOFOSBUVIR/VELPATASVIR/

VOXILAPREVIR

PROTOCOLO PACIENTES HEPATITIS C MONO-INFECTADOS EN LAS CPTETS AÑO FISCAL 2015-16

CPTET

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Iniciales/Ultimos

4 del Seguro

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Ponce M MCA-5331 1 1 1 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M MRM-4223 1 1 1 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M RTC-7578 1 1 1 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce F RCL-2472 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M OGR-2944 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce F SRL-5738 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M MAN-6068 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M MVJ-2962 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M LLE-8164 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M LOF-4168 1 1 1 COMPLETARON TRATAMIENTO 12

Ponce M ADC-3642 12

Ponce M VLR-7950 12

PROTOCOLO PACIENTES HEPATITIS C MONO-INFECTADOS EN LAS CPTETS AÑO FISCAL 2015-16

CPTET

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Mayaguez M DGG-4645 1 2 1 2 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M SRD-7437 1 2 1 2 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M CSN-1696 1 2 1 2 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M MMF-8807 1 2 1 2 1 2 COMPLETARON TRATAMIENTO 12

Mayaguez M RME-8556 1 2 1 2 1 2 COMPLETARON TRATAMIENTO 12

Mayaguez F NQN-2991 1 2 1 2 1 2 COMPLETARON TRATAMIENTO 12

Mayaguez F UPG-1605 1 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M MAI-9577 1 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M HMM-2095 1 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M OSE-8503 1 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez F DD-0858 1 1 1 COMPLETARON TRATAMIENTO 12

Mayaguez M VMC-6777 16

Mayaguez M VRS-1510 12

Mayaguez M RCE-9689 12

PROTOCOLO PACIENTES HEPATITIS C MONO-INFECTADOS EN LAS CPTETS AÑO FISCAL 2015-16

CPTET

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CLET F GOI-1658 1 2 1 2 1 1 COMPLETARON TRATAMIENTO 12

CLET M DGD-8928 1 1 1 COMPLETARON TRATAMIENTO 12

CLET F RMC-0466 1 1 1 COMPLETARON TRATAMIENTO 12

CLET M VOM-0089 1 1 1 COMPLETARON TRATAMIENTO 12

CLET F MFP-8152 1 1 1 COMPLETARON TRATAMIENTO 12

CLET M DFN-2456 1 1 1 COMPLETARON TRATAMIENTO 12

CLET M RRC-4635 1 2 1 2 1 2 COMPLETARON TRATAMIENTO 12

CLET F MDL-3821 1 1 12

CLET M CMR-7682 1 2 1 2 1 2 COMPLETARON TRATAMIENTO 12

CLET M PNC-0611 1 2 12

CLET M PNJ-8462 1 12

CLET M CRJ-0236 1 12

CLET M GVV-2294 1 2 12

TOTAL 22 3 5 22 2 5 20 3 5 18 2 3 20 3 5 14 1 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

65,78

34,21

Monoinfected HCV Patients Refered to Clinical Centers Pilot Project

OCASET from September 1st 2015 until March 30th 2017 *

Terminaron TX 65.78%(n=25)

En Tratamiento 34.21% (n=13)

• Actualización a Marzo 2017

• Iniciaron tratamiento con medicamentos un total de 40 pacientes mono-infectados

Evaluados por los médicos tratantes de hepatitis C.

De estos 40 pts. un total los 40 pacientes completaron el tratamiento.

De los 40 pts que iniciaron tratamiento, 10 son féminas y 30 varones.

28 pacientes Genotipo 1a.

5 paciente genotipo 1b.

5 pacientes Genotipo 3.

1 paciente genotipo 2.

1 paciente genotipo 4.

13 pacts. F4 con Cirrosis.16 pacts. F4 sin Cirrosis.10 pacts. F3.1 pct. Sin estadio de Fibrosis porque es Post-trasplantado.

Pilot Protocol Hepatitis CCo infected Patients CPTETS

Fiscal Year 2015-18

PROFILE OF HIV/HCV CASES REFERRED TO PILOT PROJECT SEPTEMBER 2015 TO MARCH 2018 (n = 323)

MEAN AGE

52 Y/O

TREATMENT-NAÏVE

233(72%)

TREATMENT-EXPERIENCED

90 (28%)

FEMALE

77 (24%)

MALE

24 (7%)

PREFERRED REGION OF TREATMENT

BAYAMON: 14 (4%)

CAGUAS: 41 (13%)

PONCE: 53 (16%)

MAYAGUEZ: 25 (8%)

SAN JUAN: 190 (59%)

MEAN

APRI

1.41

62%

F3 TO F4 STAGE

MEAN HCV RNA VIRAL LOAD

8,509,092

FIBROSIS STAGE HIV/HCV CASES

8% 6%

24%

15%

47%

0

10

20

30

40

50

F0 F1 F2 F3 F4

DISTRIBUTION OF GENOTYPE IN HIV/HCV CO-INFECTED CASES (n = 323)

254 (79%)190/254 (75%)

ARE SUBTYPE 1A

27 (8%)

30 (9%)

8 (2%) 4 (1%)

GENOTYPE 1

GENOTYPE 2

GENOTYPE 3

GENOTYPE 4

GENOTYPE 5

GENOTYPE 6

NO AVAILABLE

OVERALL RESULTS BY MARCH 2018

68%

(183/270)

•COMPLETE DAA

REGIMEN

72%

(132/183)

•SOFOSBUVIR BASED DAA REGIMEN UTILIZATION

97%

(180/183)

• SUCCESFUL RATE (SVR)

Puerto Rico Hepatitis C Estimates 2014-2035

Overall Projections

Polaris Observatory

The Road to Elimination by 2030

WHO Global Hepatitis Report, 2017. Accessible at: http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1 (accessed May, 2017).

Global Health Sector Strategy on viral hepatitis: 2015 baseline towards the 2030 targets

Observations

• The Base scenario describes the disease burden at the time of country meetings.

• The Base 2015 scenario describes the disease burden using the 2015 treatment paradigm.

• Actual treated patients in the 2015 were the number of treated patients between Jan-June of 2015. This value was multiplied by two to get an estimate for a full year.

• The WHO Target scenario describes the integrated healthcare strategy proposed by World Health Organization which includes:

a) 90% reduce in new infections,

b) 90% increase in diagnosis rate,

c) 80% treatment eligibility, and

d) 65% reduction in HCV mortality in 2030, compared to base in 2030.

Polaris Observatory, 2017WHO. Global Health Sector Strategies for Viral Hepatitis, 2016-2021, 22 April 2016

Puerto Rico Hepatitis C Estimates 2014-2035

Puerto Rico Hepatitis C Estimates 2014-2035

Puerto Rico Hepatitis C Estimates 2014-2035

Puerto Rico Hepatitis C Estimates 2014-2035

Puerto Rico Hepatitis C Estimates 2014-2035

Puerto Rico Hepatitis C Estimates 2014-2035

Conclusions: (Politically correct)

• Engagement from country, civil society, sponsor donors and policymakers is needed to generate political will and commitment, mobilize resources and reduce diagnostic and medicine costs.

• Countries should estimate resources required to implement HCV prevention, screening and treatment strategies and their expected health, societal, and financial benefits to reach domestic and international funding.

• Development of HCV prevention, screening, treatment and strategic matrix into well established HIV/AIDS programs for financial and infrastructure work-force efficiencies is a must.

• New and short duration regimens of DAA have the potential to facilitate treatment and improve outcomes

Conclusions: (Politically incorrect)

• We have the knowledge

• We have the tools, strategies and modelling planning

• There is an established infrastructure of care for HIV that can be utilized in many places

• Prices have gone down and or generics are becoming available

• We need to stop BUREACRACY within states and countries.

• There is and will never be Universal Pricing for drugs

• Governments will need to develop and implement sensible programs

• We need social, political, patient advocacy, cultural mingle and a “Will” to execute…

“The moment is now, stop the excuses”

Acknowledgements

• Dra. Celeste Rodriguez Ryan White ADAP

• Dra. Norma Delgado Ryan White ADAP

• Dr. Geronimo Torres OCASET Dept. Salud

• Sra. Sandra Miranda MPH; Dept. Salud

• Dr. Hermes Garcia CLETS/OCASET

• Dr. Greduvel Duran OCASET Dept Salud

• Srta. Nilsa Martinez UDH Salud

GRACIAS