1. Fabio Mesquita, MD, PhD Director of the Brazilian Ministry of Health’s HIV/AIDS and Viral Hepatitis Department www.aids.gov.br July 20th, 2014 Evidence and Policy Gaps on ART at 500 CD4, TasP and PrEP: Why are we not scaling up the use of ART more aggressively?

2. Clinical Protocol and Therapeutic Guidelines for Management of the HIV Infection in Adults Launched on World AIDS Day and published by Ordinance No. 27, on November 29, 2013 30 days’ public consultation Published online as well as in PDF format, allowing for simpler and faster review of recommendations.

3. Establishing lines of treatment First-line: Preferred regimen – TDF + 3TC + EFV Alternative NRTIs: Zidovudine, abacavir, didanosine Alternative NNRTIs: Nevirapine Second-line: Preferred PIs: LPV/r Alternative PIs: Atazanavir, fosamprenavir (with ritonavir booster) Third-line: Darunavir/r, Tipranavir/r, Raltegravir, Etravirine, Maraviroc, Enfuvirtide Dispensing of alternative ARV drugs to new patients - rather than preferred regimen - only when justified by doctor.

4. Brazil incorporates TasP in its national recommendations  Treat every HIV positive regardless CD4  Reduced transmissibility: reduction in HIV transmission in HAART early treatment  Clinical benefits by decreasing inflammatory action and aging effects related to the HIV infection  We don’t need any more scientific data: we must prevent viral replication from occurring by intervening

5. A continuous increase in people in ART

6. In 2014, the CD4 counts of 40% of the patients who began treatment was greater than 500 Distribution of individuals who began ART according to CD4 counts carried out 6 months earlier at most, by year of beginning in Brazil, 2009-2014* (*) Up to June 2014.

7. Our goal for 2014: at least 100 thousand more people in treatment New PLWHA on ART in the first semester of each year. Brazil, 2012-14 2014: a 30% increase, approximately, when compared to the same period in 2013

8. PrEP  We need more information to implement this as a public policy – to assess the possible impacts of its use in real life, outside of the controlled environment of a clinical trial – adhesion, use of other prevention methods, disinhibition etc. In Brazil:  Studies for its implementation in health services are in progress

9. Sustainability of the universal access policy in Brazil  Price negotiation;  National production: 13 of the 37 types of antiretroviral drugs available in the Brazilian public health system are nationally produced;  Rational use of ARVs: only 5% of the patients in third-line ART – third-line drugs alone are responsible for 35% of the total cost of ARVs.  Presently: 350 thousand people in ART – 75% present undetectable VLs

10. Challenges to expanding treatment  Treatment simplification: use of combined fixed doses and regimens with greater dosing convenience;  Rational use of antiretroviral drugs: sequential use of ARVs to sustain treatment success for as long as possible;  Priority to begin treatment given to patients according to clinical and immunological criteria X early treatment for everyone, without distinction;  A new model of attention to HIV – increased access to and quality of treatment resulting from the involvement of primary care in ARV management;  Global challenges for funding the HIV response in next few years, taking into account that communicable diseases are now less of a priority in the international agenda;  ARV costs in a scenario in which there is a continuous increase of new patients in treatment.