Advances in HIV science and treatment. Report on the global AIDS epidemic,

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1 HIV biomolecular advances and treatment updates David A Cooper National Centre in HIV Epidemiology and Clinical Research The University of New South Wales Sydney, Australia

2 UNAIDS: global l HIV infections 2007 Report on the global AIDS epidemic,

3 UNAIDS: epidemiology i Global Sub-Saharan Africa Report on the global AIDS epidemic,

4 UNAIDS: number of people receiving i ART in LMIC millions Report on the global AIDS epidemic,

5 basic science treatment prevention

6 Basic science HIV advances and updates- basic science

7 Basic science HIV advances and updates- basic science Host proteins required for HIV infection large scale screen using small interfering RNA (sirna) to identify host factors required for successful HIV replication identified >250 HIV-dependency factors (HDF) large number of potential therapy targets identified Brass et al, Science 2008

8 Basic science HIV advances and updates- basic science Brass et al, Science 2008

9 basic science treatment prevention

10 Treatment HIV advances and updates- treatment t t

11 Treatment ART-CC: HAART treated t patients t do not have a normal life span, particularly if HAART is started late (n=43 43,000, all treatment naïve) CD4 nadir < >200 potential years of life lost before age of (per 1000 person-yrs) life expectancy, years (at age 20) depending on when HAART is started, life expectancy during modern HAART era is 10 to 30 years less than that in uninfected patients Hogg et al; Lancet 2008 (see also Lohse AIM 2007 and Bhaskaran JAMA 2008)

12 Treatment ART-CC: health indicators for overall population mortality rates (per 1000 person-years) overall 16 3 ( ) 12 4 ( ) 10 0 ( ) 12 0 ( ) years ( ) 14 7) 10 3 ( ) (68 ( ) 83) ( ) (91 10 potential years of life lost before age 65 years (per 1000 person-years) years life expectancy (years; adjusted) at exact age 20 years at exact age 35 years 36 1 (SE 0 60) 41 2 (SE 0 52) 49 4 (SE 0 54) 43 1 (SE 0 33) 25 0 (SE 0 42) 30 1 (SE 0 31) 37 3 (SE 0 37) 31 7 (SE 0 21) % surviving from 75 5% 79 5% 85 7% 81 1% 20 to 44 years Mortality rates are deaths per 1000 person-years (95% CI)

13 Treatment ART-CC: crude and standardised di d mortality rates Hogg et al, Lancet 2008

14 Treatment Targets for anti-hiv drugs Fauci Nature Medicine 2003

15 Treatment STARTMRK: efficacy percent of patients with HIV RNA <50 copies/ml RAL EFV 86% 82% non-inferiority p-value<0.001 RAL 400 mg bd EFV 600 mg qd weeks number of contributing patients *in combination with TDF/FTC

16 Treatment Ti Triple-class l failure: improved patient t outcomes study drug regimen HIV-1 RNA <50 copies/ml,% TORO ENF + OBR OBR alone RESIST TPV/r + OBR 22.8 PI/r + OBR 10.2 POWER DRV + OBR 45.0 PI/r + OBR DUET MOTIVATE BENCHMRK ETV + DRV/r containing OBR placebo + DRV/r containing OBR MVC qd+ OBR MVC bid+ OBR placebo + OBR RAL + OBR placebo + OBR

17 Treatment

18 Treatment CHER: results probability of death 377 HIV-positive infants aged 6-12 weeks with >25% CD4+ cells randomised to either: early- immediate initiation iti of ART or deferred- initiation when <20% CD4 cells or clinical criteria met probability of death or CDC event Violari et al, NEJM 2008

19 Treatment CIPRA HT 001: design and demography Randomised clinical endpoint study of when to start therapy treatment-naive no hx AIDS-defining illness CD (n=816) early treatment (immediate ZDV/3TC + EFV) standard treatment (delay until CD4+ <200 or AIDS) primary endpoint: survival baseline characteristics early (n=408) standard (n=408) median age (years) male (%) 41% 44% median CD4+ (cells/µl) Body Mass Index (kg/m 2 ) May 2009: DSMB review stopped study due to excess deaths in standard treatment arm Fitzgerald et al, IAS 2009

20 Treatment CIPRA HT 001: clinical i l endpoints early standard death 6 23 incident tuberculosis infectious causes of death early: 1 (gastroenteritis) standard: 17 (7 gastroenteritis, 5 TB, 4 pneumonia, 1 cholangitis/sepsis) i more toxicity from ART and intensive need for lab f/u for those who deferred hazards ratio (p value) 4.0 (.0011 ) 2.0 (.0125 ) investigators currently working with Ministry of Health to change start ART guidelines to 350 cells/µl Fitzgerald et al, IAS 2009

21 Treatment

22 Treatment Bone-marrow transplantation: t ti HIV clearance 40 year old male diagnosed with HIV for >10 years HAART for 4 years (TDF/FTC, EFV) acute myeloid leukemia received stem cell transplants from a donor screened for homozygous for the CCR5 32 allele no HIV DNA detected in rectal biopsy at 5 months undetectable viral load 20 months after transplantation Hutter et al, NEJM 2009

23 Treatment Bone-marrow transplantation: t ti HIV clearance HIV-RNA (copies/ml) CD4+ T cells (per mm 3 ) Hutter et al, NEJM 2009

24 Treatment activation of latently infected cells with factors such as prostratin HDAC inhibitors IL-7 HMBA in combination with HAART to protect uninfected cells from infection Potential ti eradication of HIV Richman et al, Science 2009

25 basic science treatment prevention

26 Prevention Swiss statement t t An HIV-infected person on antiretroviral therapy with completely suppressed viraemia ( effective ART ) is not sexually infectious, i.e. cannot transmit HIV through sexual contact. Vernazza et al, Bulletin des Medicins Suisses 2008

27 Prevention

28 Prevention Mathematical model: viral load and infectiousness insertive penile-vaginal transmission cumulative probability of transmission Expected number of HIV seroconversions receptive penile-vaginal transmission penile-anal transmission Wilson et al, Lancet 2008

29 Prevention Meta-analysis: analysis: viral load and infectiousness suggests low transmission when on ART with a VL <400 copies Attia et al, AIDS 2009

30 Prevention Viral load and infectiousness accurate determination of transmission rates at low VL and with ART suffers from lack of data quantifying transmission at low viral loads in the presence of ART evidence lacking in relation to condom use other STIs mode of transmission Wilson DP, AIDS 2009

31 Prevention

32 Prevention STEP: adenovirus 5 vector-based HIV-1 gag/pol pol/nef vaccine 3000 HIV-1 negative participants from 34 sites randomised to vaccine or placebo stratified by sex, Ad5 antibody titre at baseline and study site ceased due to lack of protective efficacy at interim analysis Buchbinder et al, Lancet, 2008

33 Prevention STEP: lack of efficacy Buchbinder et al, Lancet, 2008

34 Prevention STEP: cofactors Buchbinder et al, Lancet, 2008

35 Prevention Mma Bana: PMTCT in Botswana compared prevention of mother to child transmission in women on AZT/3TC/ABC versus AZT/3TC/LPV/r 560 HIV-positive pregnant women with >200 CD4 T cells/ l, commencing ART at weeks gestation 170 women included in the observational group due to <200 CD4 cells/ l, commenced AZT/3TC/NVP at weeks gestation Shapiro et al, IAS 2009, abstract WELBB101

36 Prevention Mma Bana: PMTCT Botswana ABC LPV/r observational arm p-value ABC vs LPV/r stillbirths, % NS prematurity, % suppression at birth suppression during breastfeeding MTCT, n 5 (2%) 1 (<1%) 1(<1%) 0.53 maternal AE, % NS infant mortality NS Shapiro et al, IAS 2009, abstract WELBB101

37 Prevention Pre-exposure exposure prophylaxis (PrEP) in macaques Garcia-Lerma et al, PLoS Med 2008

38 Prevention PrEP PEPi in macaques % uninfected macaques Garcia-Lerma et al, PLoS Med 2008

39 Prevention Conclusions abandon two standards of care for high and low to middle income countries implement testing and treatment for all HIVinfected infants implement HAART for all HIV-positive pregnant women to prevent MTCT improve uptake of ART by HIV-infected pregnant woman and children increase research into biomedical prevention especially vaccines, microbicides and PrEP

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