Projeto Praça Onze Universidade Federal do Rio de Janeiro. Long term treatment of chronic viral disease: lessons from HIV for HBV

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1 Projeto Praça Onze Universidade Federal do Rio de Janeiro Long term treatment of chronic viral disease: lessons from HIV for HBV Mauro Schechter Principal Investigator, Projeto Praça Onze Professor of Infectious Diseases Universidade Federal do Rio de Janeiro Les Cent Gardes: latest approaches to HIV infection management New Delhi - March 6, 2009

2 10 Leading Causes of Infectious Disease Deaths Worldwide (2000) WHO. Hepatitis B Maynard JE, et al. In: Viral Hepatitis and Liver Disease. New York: Alan R. Liss, Inc CDC. Epidemiology & prevention of vaccinepreventable diseases. The Pink Book. 8th ed. CDC. MMWR. 2001;50:RR-11.

3 Prevalence of HIV infection 33 million living with HIV

4 Prevalence of HBV infection million chronic carriers HBsAg Prevalence High ( 8%) Intermediate (2% to 8%) Low (< 2%) Mast EE, et al. MMWR Recomm Rep. 2006;55:1-33. Custer B, et al. J Clin Gastroenterol. 2004;38(10 suppl):s158-s168. HBsAg Positive, % Taiwan Vietnam China Africa Philippines Thailand Japan Indonesia 4.0 South Korea India Russia US

5 HBV: A Significant Cause of Worldwide Morbidity and Mortality 4 million acute cases per year 1 million deaths per year million chronic carriers 25% of carriers die from chronic hepatitis, cirrhosis, or liver cancer Nearly 75% of chronic carriers are Asian Second most important carcinogen behind tobacco Causes 60% to 80% of all primary liver cancers HBV is 100 times more contagious than HIV (but a highly efficacious vaccine is available)

6 Treatment of HIV infection HIV infection is not curable at present, but is controllable Viral replication, as measured by plasma viral load, is associated with prognosis Long term control of viral replication is the ultimate goal of treatment

7 Chronic HBV: Goals of Therapy HBV is probably never cured but rather controlled by limiting viral replication Viral replication, as measured by plasma viral load, is associated with prognosis Sustained suppression of HBV replication is the ultimate goal of therapy

8 Milestones in the history of HBV 1965 Australian antigen (Aa) discovered (later called HBsAg) 1983 Subunit hep B vaccine derived from serum is approved 2004 Antiviral treatment reduces disease progression HCC mortality associated with HBsAg-positivity 1983 IFN-α approved 1998 LVD approved 2006 Definitive evidence linking viral load to disease progression

9 Milestones in the history of HIV First AIDS cases reported ELISA test licensed by FDA HAART era begins First generic drug USA Estimated number of people living with HIV globally (millions) First isolation of HIV by Barré-Sinousssi AZT is licensed Leading cause of death worldwide (15 59 years)

10 Therapy for Chronic Hepatitis B: IFN alfa LAM ADV ETV LdT PegIFN alfa-2a TDF

11 Antiretroviral drugs 2008 Retrovir Truvada Combivir Epzicom Aptivus Hivid Epivir Rescriptor Ziagen Lexiva Viramune Fuzeon Videx Zerit Sustiva Trizivir Atripla Viracept Kaletra Reyataz NRTI PI Invirase Fortovase Viread Prezista NNRTI Integrase Inhibitor Fusion Inhibitor CCR5 inhibitor Norvir Crixivan Agenerase Emtriva Celsentri Isentress Intelence

12 Lessons from HIV for HBV What are the main unresolved issues and unmet needs in HBV treatment What are the main achievements in HIV therapy

13 The main achievements in HIV therapy Licensure of over two dozen drugs with 5 different mechanisms of action Transformation of an universally fatal disease into a chronic, manageable condition

14 A Brief History of Antiretroviral Therapy

15 A Brief History of Antiretroviral Therapy Proportion surviving Months after diagnosis Survival after diagnosis of OI, USA

16 A Brief History of Antiretroviral Therapy Mortality and protease inhibitor use in patients with CD4 <100, US (Palella, NEJM 1998)

17 A Brief History of Antiretroviral Therapy First trial with Indinavir + AZT + Lamivudine Gulick et al. NEJM 1997; 37:725-33

18 A Brief History of Antiretroviral Therapy HAART and viral load <500 Copies/uL, Johns Hopkins Cohort, year

19 Efficacy of HAART Unboosted PI NNRTI NRTI Boosted PI % with viral load < 50 on week 48 Bartlett JA, Abstract 586.

20 Response to treatment in the first year of HAART 5 cohorts in Europe and Canada N=4,143 Treatment naïve, started HAART % with VL > % com CV > 500 c/ml Aumento median de CD Median CD4 gain Lampe S, et al. 12 th CROI, 2005, Abstract 593

21 Efectiveness of HAART Eurosida: Combined rates of AIDS and death (Lancet 2003).

22 Efectiveness of HAART Year Intervention Survival after AIDS (months) # New AIDS cases Total gain (years) PCP ,370 40, PCP+MAC , , PCP+MAC + pré-haart , , PCP+MAC + HAART , , PCP+MAC + HAART , , PCP+MAC + HAART , ,189 TOTAL 2,813,892 Walensky, JID 2006

23 Survival with HAART and with commonly used interventions Walensky R, et al. JID 2006;194:11-19.

24 The main achievements in HIV therapy Licensure of over two dozen drugs with 5 different mechanisms of action Transformation of an universally fatal disease into a chronic, manageable condition ACTIVISM FROM AFFECTED COMMUNITIES IN DEVELOPED COUNTRIES FORCED GOVERNMENTS AND INDUSTRY TO ACT

25 The main achievements in HIV therapy Licensure of over two dozen drugs with 5 different mechanisms of action Transformation of an universally fatal disease into a chronic, manageable condition Massive scale up of treatment in developing countries is underway

26 Durban 2000 Activism from the South Global March for access to HIV treatment Treatment Access Campaign (and others) EVERYONE HAS THE RIGHT TO HEALTH! All people with HIV/AIDS have a right to access treatments in addition to health care, employment, education, clean water, adequate nutrition, and housing. Denying people with HIV/AIDS access to affordable medicines in order to protect profits or intellectual property rights, is tantamount to genocide.

27 2001 Global Commitment Kofi Annan, UN Secretary General: Call for 7 10 billion war chest against AIDS and the creation of the Global Fund (launched Jan 2002) we must put care and treatment within everyone's reach. UNGASS AIDS, June 2001, Declaration of Commitment: make every effort to provide the highest attainable standard of treatment for HIV/AIDS, including the effective use of qualitycontrolled anti-retroviral therapy

28 The launch of 3 by 5 I will ensure that WHO provides leadership toward the bold "3 by 5" target: three million people in developing countries on antiretroviral treatment by 2005." Dr Lee Jong-wook, Director General WHO Inaugural speech, Geneva, May 2003 With the support of technical partners, Round 4 of Global Fund proposals launched in January became the HIV treatment round

29 The Presidential Emergency Plan for AIDS Relief AIDS can be prevented. Anti-retroviral drugs can extend life for many years. And the cost of those drugs has dropped from $12,000 a year to under $300 a year which places a tremendous possibility within our grasp. Ladies and gentlemen, seldom has history offered a greater opportunity to do so much for so many. George W. Bush, January 2003 Target: 2 million PLWHA on treatment by 2007

30 Initial Response to Therapy ART-CC* ART-LINC* Brazil** 6 months response VL<500 copies 14,825 (77.0%) 1,527 (76.0%) 327 (72.0%) CD4 increase 103 (32 192) 106 (43 180) 117 (60 197) Baseline characteristics Male sex 16,731 (75.0%) 2,349 (49.0%) 296 (65.2%) Age 36 (31 43) 36 (30 42) 36 (31 43) CD4 count 234 (98 380) 108 (37 210) 156 (47 253) Baseline regimen NNRTI based 5,125 (23.0%) 3,391 (70.0%) 179 (39.5%) PI based 13,783 (62.0%) 900 (19.0%) 266 (58.6%) *Braitstein et al; Lancet 2006; 367: **Tuboi et al; JAIDS 2005; 40:

31 ART-LINC vs. ART-CC: Cumulative mortality after 12 months on HAART 6.4% ( ) 1.8% ( ) Braitstein et al; Lancet 2006; 367:

32 Mortality by baseline CD4 cell count Cumulative mortality (%) Sub-Saharan Africa Europe & North America < 25 cells/µl cells/µl cells/µl cells/µl > 200 cells/µl Months after starting ART CROI 2007 mortality - 32

33 Mortality in the first year of HAART: ARTC-LINC vs. ART-CC 16 8 Hazard ratio (95% CI) Months from starting HAART HR undajusted HR adjusted *cohort, age, sex, baselines CD4, HAART regimen, stage of disease Braitstein et al; Lancet 2006; 367:

34 Most common OIs in first 3 months TB (pulmonary / extrap.) Herpes simplex disease Cryptococcal meningits Pneumocystis pneumonia Oesophagial candidiasis Kaposi s sarcoma Toxoplasmosis of the brain Bacterial pneumonia, recurrent TB (pulmonary / extrap.) Kaposi s sarcoma CMV disease Pneumocystis pneumonia Other mycobacterial disease Oesophagial candidiasis Wasting Encephalopathy Sub-Saharan Africa Europe & North America Arch Intern Med. 2005;165: Incidence rate (cases / 1000 pyrs) CROI 2007 OIs 28

35 Mortality in the Rio HIV cohort, A B Non-AIDS AIDS Rates/100 person-years Rates/100 person-years Period Deaths Period AIDS and Non-AIDS-related causes of death Pacheco, submitted

36 Causes of Mortality in HIV infected Individuals According to Death Certificates, Brazil % N= 5,856,056 HIV = 67,249 Annual rate: 6.4/100, Non HIV associated TB Pacheco 2008

37 Odds Ratio for Cardiovascular Disease or Diabetes Mellitus on Death Certificates (reference year = 1999) A B HIV Not HIV HIV Not HIV ORs with 95% CIs ORs with 95% CIs N= 5,856,056 HIV = 67, Years Years Pacheco 2008

38 The main achievements in HIV therapy Licensure of over two dozen drugs with 5 different mechanisms of action Transformation of an universally fatal disease into a chronic, manageable condition Growing impact of co-morbidities Data from developed countries not completely transposable to developing countries

39 Lessons from HIV for HBV Activism drives investment and the research agenda Research agenda drives treatment policy Clinical research has to be conducted both in developed and in developing countries Provides academic education and training Allow early access to treatment

40 Obrigado!!! Thank You!!! Merci!!!

41

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