Fabio Mesquita, MD, PhD Director of the Brazilian Ministry of Health’s

1. Evidence and Policy Gaps on ART at 500 CD4, TasP and PrEP: Why are we not scaling up the use of ART more aggressively? 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

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.