Generics – what can be done Dr Andrew Hill Department of Pharmacology and Therapeutics University of Liverpool United Kingdom IAS Paris, Wednesday 26th Julu 2017

ART Coverage by country, 2016 19 ART Coverage by country, 2016 19.5 million on ART, but funding cuts on the way

Global ART treatment demand will rise by 800,000 per year, unless HIV infection rates fall 1.8 million new HIV infections* /year Need for ART (90-90-90): 30 million in 2017 32.4 million in 2020 36.4 million in 2025 1 million HIV-related deaths*/year *REF: http://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf

Hepatitis C: net cure rates in 2016, by country 1 Hepatitis C: net cure rates in 2016, by country 1.5 million people cured, 1.6 million new infections < 1% 1% - 7% > 7% Hill et al. J Vir Erad, July 2017, 3: 117-123

$90 $90 $90: Prices and costs of treating HIV, HBV, HCV and TB DRUG USA PRICE GLOBAL LOWEST PRICE TARGET PATENT EXPIRY (US) HIV: TDF/3TC/EFV $28,204 $100 $78 Generic HBV: TDF/FTC $17,258 $67 $54 2017-2032 HCV: SOF+DCV $142,710 $108 $47 2028-2031 TB: RHZE $945 $27 $38 HIV and HBV: price per year. HCV: price per 12-week course, TB: per 6 month course, Patent expiries from US FDA Orange Book, for solid oral dosage forms only.

$200 billion in HIV drug sales 2002-2016

Gilead sales and profits Cumulative sales of Sovaldi & Harvoni until 1Q 2017: $49 billion Profits in 2015: $18 billion Reference: Gilead quarterly product sales summaries

Generics can be cheap worldwide

in any country. High quality, WHO approved Generic TDF/3TC/EFV should also be available for prices close to $90/year, in any country. High quality, WHO approved Cipla – Tenvir-EM Mylan – Revcovir-EM

“Throwing the kitchen sink” at HIV Same day testing and treatment Treating all patients, at any CD4 count “No questions asked” approach to chemsex Regular follow up with text reminders PEP PrEP

Reductions in new HIV+ diagnosis per month, 56 Dean Street London, 2015-2017 72 15

Conclusions - HIV The patents on tenofovir, 3TC and efavirenz have expired. The TDF/3TC/EFV tablet should be available in any country for $90 per year, or a similar price We should then be measuring the value of new drugs like TAF or DTG versus this $90 price. This new economics could lead to a cascade of price reductions worldwide, and the chance to treat far more people on limited budgets. The money saved could then be spent on PEP, PrEP and more HIV testing. This could drive down HIV incidence significantly.

Conclusions – Hepatitis C Worldwide, for every person cured of Hepatitis C in 2016, another person was newly infected. We will not reach elimination of HCV at the current price levels A $90 unit price per cure can be achieved. However, we need more donor funding and commitments from national health authorities.