The Future of HIV Treatment Greg Perry Melbourne – International AIDS Conference July 2014

1. The Future of HIV Treatment Greg Perry Melbourne – International AIDS Conference July 2014

2. The Future of HIV Treatment? All people on treatment have access to the best possible regimens Treatment side effects are minimal or non-existent People can stay on the same treatment without developing resistance Cost is no longer a barrier in determining which treatment to take The most effective regimens are available as once-daily single tablet regimens or in long-acting formulations Children have access to the best possible treatment that is suitable for their age

3. Recent progress in HIV treatment • According to UNAIDS 12.9 million PLHIV were accessing treatment in end 2013 • Drugs with higher toxicity (e.g. d4T) are being replaced with better drugs • Price of TDF-based first-line treatment has come down significantly in most countries • Lower cost second line treatments increasingly available in many developing countries

4. New Medicines Being Developed • 4 new ARVs approved since 2011 • 2 new single tablet regimens since 2011 and more in development • There are new drugs with lower side effects and potential for being cheaper than current drugs • Long-acting formulations under study that could enhance treatment options

5. Some Challenges • Accelerating availability of new ARVs in developing countries • Ensuring new ARVs become available in the most suitable formulations • Promoting robust market competition to bring down prices of new treatments 9.7 million have access to treatment

6. Medicines Patent Pool Partnering for Innovation and Access PATENT HOLDERS MANUFACTURERS PEOPLE LIVING WITH HIV Sub- Licences Licences Medicines ROYALTIES Established in 2010 with the support of

7. 1. AcceleratingAvailability of New ARVs in Developing Countries 7

8. Long Lag from Originator Market Approval to Generic Availability • Time from FDA approval of new ARV molecules to availability of quality assured generics for developing countries has generally been between 5 to 10 years Timeline From Originator Approval to Generic Availability: FDA/EMA Approval Generic Approvals Years Could the future look like this? FDA/EMA Approval Generic Approvals Years

9. Patents on new ARVs could delay the timeline even further * Secondary patents on some of these products may extend patent protection beyond the date shown.

10. Accelerating availability of new medicines in developing countries through voluntary licensing Availability of quality generics can be accelerated by licensing medicines during final phase of development or shortly after approval and managing licences to accelerate developmentand registration * As part of the QUAD

11. 2. Ensuring ARVs Become Available In The Most Suitable Formulations 11

12. Licensing to Facilitate Fixed Dose Combinations • Fixed-dose combinations improve treatment adherence for adults and children alike • But face particular patent challenges: • Patents on one component can impact access to entire regimen • Patents on the combinations No patent  Patented Patented No patent • Within the MPP, patents are “pooled” in one place, easing the development of new FDCs Patented, but licensed to MPP Patented, but licensed to MPP

13. ARV Formulations For Children Current pediatric formulations of HIV medicines are often inappropriate (e.g. alcohol based, bitter liquids, require refrigeration, not available as FDCs). • Simpler treatment options • Suitable for different age groups • Fixed-dose combinations Key missing formulations identified by WHO Paed AIDS Working Group • AZT or ABC/3TC/LPV/r • ABC/3TC/EFV • DRV/r • TDF/3TC(or FTC)/EFV) • ATV/r • RAL • DTG based combinations • COBI as an alternative booster to RTV

14. The Paediatric HIV Treatment Initiative Launched in May 2014. A UNITAID-MPP-DNDi-CHAI initiative • Goal: • To ensure that appropriate and affordable medicines are available to the World’s 3.3 million children living with HIV. • Key focus: partner with all stakeholders to: • Share IP and data on formulations and access • Accelerate development of urgently needed paediatric ARV formulations • Effectively shape the paediatric HIV market

15. New ARV formulations for adults Most recently approved single tablet regimens: • TDF/FTC/EVG/COBI • TDF/FTC/RPV Fixed-dose combinations under development: • ABC/3TC/DTG • TAF/FTC/EVG/COBI • TAF/FTC/DRV/COBI Other combinations recommended by the CADO 2 Conference for study that could be equally or more potent, durable and affordable than currently recommended treatments: • TAF/3TC(or FTC)/EFV • TAF/3TC(or FTC)/DTG • DTG+DRV/r Green: Licensed to the MPP or in negotiations Black: Compound patent expired or licensed bilaterally Orange: Not currently licensed Note: licences cover countries accounting for 87% to 93.4% of PLHIV in developing countries, depending on the licence

16. 3. Promoting Robust Market Competition For New Patented ARVs 16

17. Role of market competition in price reduction: case of tenofovir 1

18. Medicines Patent Pool Out-Licensing • Promoting robust generic competition through non-exclusive licensing to qualified manufacturers • MPP has licensed 7 ARVs to 10 generic partners: • TenofovirDisproxilFumarate • Emtricitabine • Elvitegravir • Cobicistat • Abacavirpaediatric • Atazanavir • Dolutegravir • Currently managing 35 sub-licences

19. Proportion of people living with HIV by country income category, 2000 - 2020 Key Challenge: inclusion of certain middle-income countries in licences Source: UNAIDS, IMF 2012

20. One possible approach to address challenge in some MICs • Market Segmentation (public/private) • In many countries, national treatment programs cater for vast majority of people on treatment • Generics able to supply national treatment programs • Originators continue to cater for small private market • Introducing royalties that are differentiated according to countries’ socio-economic circumstances • Enables countries to benefit from robust generic competition which results in lower prices • Royalty could take into account different variables: GDP per capita, inequality, disease burden, others