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TEST AND ...
TO TREAT OR NOT TO TREAT?
                                           Roger TATOUD, Ph.D
International HIV Clinical Trials Research Management Office
                                       Imperial College London



                                              Vienna, 17thJuly 2010
                                              MSM Global Forum
DOES IT WORK? CAN IT WORK?
   Relevance of mathematical modelling

          Velasco-Hernandez JX, et al. Could widespread use of combination antiretroviral therapy eradicate HIV epidemics?. Lancet Infect Dis
           2002; 2: 487-493.

          Granich RM, et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission:
           a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. Epub 2008 Nov 27.

              testing all adolescents and adults at least 15 years old once a year...
              90% programme coverage by 2016 with immediate start (2010)
              The funding needed to implement the theoretical strategy for an epidemic of South African-type severity peaks in 2015 at $3·4 billion
               per year (range $2·2 billion—$5·3 billion)

   Echoing the Swiss Statement

          “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.”

        This statement is valid as long as:

          the person adheres to antiretroviral therapy, the effects of which must be evaluated regularly by the treating physician, and
          the viral load has been suppressed (< 40 copies/ml) for at least six months, and
          there are no other sexually transmitted infections.

   Prevention of Mother to child Transmission

          In 2008, 45% [37%-57%] of HIV-positive pregnant women in low- and middle-income countries received ARV, up from 35% in 2007 and
           10% in 2004.
COST EFFECTIVE?

                                                 Cost-effectiveness estimates in low-
                                                 and middle-income countries
                                                 Bongaarts J Science. 2010 Jun
                                                 11;328(5984):1359-60.




     “People are struggling to find resources                  “Virtually every day, we have to turn
     to honor the commitments we have                          away patients who need treatment,
     made.”                                                    including breast-feeding women.”

     “We’re not at a cap point yet. If it gets                 “We have to tell them ‘There is a
     worse, we’ll have another discussion.’’                   freeze.’”


    Ambassador Eric Goosby                                    Dr Peter Mugyenyi
    US global AIDS coordinator                                Joint Clinical Research Center. Kampala, Uganda

                                                                                              Boston Globe April 11, 2010
HUMAN RESOURCES AND EFFICIENCY
                                                  Healthcare Worker         Country           Number/1000

                                                                            Malawi                0.02
                                                      PHYSICIAN
                                                                            Uganda                0.12
                                                                              UK                  2.14
                                                                            Malawi                0.28
                                                       NURSE
                                                                            Uganda                1.31
                                                                              UK                   5.8
                                                                            Malawi                0.03
                                                     LABORATORY
                                                                            Uganda                0.06
                                                     PERSONNEL
                                                                              UK                  0.34
Source : AVERT


Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a
randomised non-inferiority trial.
Sanne I. et al, The Lancet Jul 03, 2010, Volume 376

HIV-positive individuals with a CD4 cell count of less than 350 cells per μL or WHO stage 3 or 4 disease were
randomly assigned to nurse-monitored or doctor-monitored ART care.

408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all
participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the
nurse group and 179 (44%) in the doctor group.
IMPLEMENTABLE ?
     Developing World                   Developed World




                                  Style over stigma:
                                  The designer sexual health clinic
                                  that could be mistaken for a
                                  boutique hotel.
                                  (Daily Mail Reporter 12/05/09)




Functionality over Style:
Providing the minimum to ensure
diagnosis, treatment and care.
STIGMA, DISCRIMINATION, OSTRACISM




 Wat Phra Baht Nam Phu, Lop Bury, Thailand   Pasargadae Palace, Iran - Cyrus the great last resting place




                                                      No Testing = No Treating



     Likoma Island, Lake Malawi
IS IT ETHICAL?
   Universal Testing or Coerced Testing?
   Treating people who do not feel unhealthy
   Evidences from Clinical Trial (START Trial – HPTN 052)
   Putting the onus on the HIV positive

“we have to be careful that "treatment as prevention"
  doesn't slide into "forced treatment as prevention."
  Indeed, both of these strategies expose the blunt self-
  interest of the HIV negative. Maybe if we cared about
  both HIV-negative and HIV-positive people equally, our
  strategies might better reflect a mutual respect?
100 M HURDLES

     Infrastructure

            Personnel

                        Test
                               Treat
                                       Follow up

                                                   Adherence

                                                         Resistance

                                                                 2nd Line
TEST AND TREAT... AND OTHER NPTs




                 Let’s not forget what worked and works.

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ARV Treatment for the Prevention of HIV Transmission

  • 1. TEST AND ... TO TREAT OR NOT TO TREAT? Roger TATOUD, Ph.D International HIV Clinical Trials Research Management Office Imperial College London Vienna, 17thJuly 2010 MSM Global Forum
  • 2.
  • 3. DOES IT WORK? CAN IT WORK?  Relevance of mathematical modelling  Velasco-Hernandez JX, et al. Could widespread use of combination antiretroviral therapy eradicate HIV epidemics?. Lancet Infect Dis 2002; 2: 487-493.  Granich RM, et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. Epub 2008 Nov 27.  testing all adolescents and adults at least 15 years old once a year...  90% programme coverage by 2016 with immediate start (2010)  The funding needed to implement the theoretical strategy for an epidemic of South African-type severity peaks in 2015 at $3·4 billion per year (range $2·2 billion—$5·3 billion)  Echoing the Swiss Statement  “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.” This statement is valid as long as:  the person adheres to antiretroviral therapy, the effects of which must be evaluated regularly by the treating physician, and  the viral load has been suppressed (< 40 copies/ml) for at least six months, and  there are no other sexually transmitted infections.  Prevention of Mother to child Transmission  In 2008, 45% [37%-57%] of HIV-positive pregnant women in low- and middle-income countries received ARV, up from 35% in 2007 and 10% in 2004.
  • 4. COST EFFECTIVE? Cost-effectiveness estimates in low- and middle-income countries Bongaarts J Science. 2010 Jun 11;328(5984):1359-60. “People are struggling to find resources “Virtually every day, we have to turn to honor the commitments we have away patients who need treatment, made.” including breast-feeding women.” “We’re not at a cap point yet. If it gets “We have to tell them ‘There is a worse, we’ll have another discussion.’’ freeze.’” Ambassador Eric Goosby Dr Peter Mugyenyi US global AIDS coordinator Joint Clinical Research Center. Kampala, Uganda Boston Globe April 11, 2010
  • 5. HUMAN RESOURCES AND EFFICIENCY Healthcare Worker Country Number/1000 Malawi 0.02 PHYSICIAN Uganda 0.12 UK 2.14 Malawi 0.28 NURSE Uganda 1.31 UK 5.8 Malawi 0.03 LABORATORY Uganda 0.06 PERSONNEL UK 0.34 Source : AVERT Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Sanne I. et al, The Lancet Jul 03, 2010, Volume 376 HIV-positive individuals with a CD4 cell count of less than 350 cells per μL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. 408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group.
  • 6. IMPLEMENTABLE ?  Developing World  Developed World Style over stigma: The designer sexual health clinic that could be mistaken for a boutique hotel. (Daily Mail Reporter 12/05/09) Functionality over Style: Providing the minimum to ensure diagnosis, treatment and care.
  • 7. STIGMA, DISCRIMINATION, OSTRACISM Wat Phra Baht Nam Phu, Lop Bury, Thailand Pasargadae Palace, Iran - Cyrus the great last resting place No Testing = No Treating Likoma Island, Lake Malawi
  • 8. IS IT ETHICAL?  Universal Testing or Coerced Testing?  Treating people who do not feel unhealthy  Evidences from Clinical Trial (START Trial – HPTN 052)  Putting the onus on the HIV positive “we have to be careful that "treatment as prevention" doesn't slide into "forced treatment as prevention." Indeed, both of these strategies expose the blunt self- interest of the HIV negative. Maybe if we cared about both HIV-negative and HIV-positive people equally, our strategies might better reflect a mutual respect?
  • 9. 100 M HURDLES Infrastructure Personnel Test Treat Follow up Adherence Resistance 2nd Line
  • 10. TEST AND TREAT... AND OTHER NPTs Let’s not forget what worked and works.