Hepatitis C Generic Drugs - Stuart Flanagan
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Stuart Flanagan Presentation, Uniting Voices for HCV Elimination Meeting 4/07/16
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Hepatitis C Generic Drugs - Stuart Flanagan
- 1. Hepatitis C Generic Drugs Stuart Flanagan Clinical Research Fellow, QMUL
- 2. Declarations • I have received travel bursaries, conference bursaries and honoraria from AbbVie/Bristol-Myers-Squibbs/Gilead/Janssen
- 3. 1. Josep Lago/AFP/Getty Images 2. Mark Wilson/Getty Images
- 4. What are Generic Medicines • Contain the same active medicinal substance as an originator pharmaceutical product. • Usually launched when originator product’s patent has expired (“off-patent”) • Prior to patent expiry Pharma companies can set price • Poorest countries are not subject to intellectual property laws that lead to higher prices • Copies of current therapies can be mass produced
- 5. Costs Hill et al CID 2014
- 6. Factors considered in pricing of HCV drugs Gilead Internal from Senate Report 2015
- 7. How Accessible are Generics?
- 8. How Safe are Generics? Patients may ask you about your thoughts on Generics… • Are they safe? • Will they work? • Will you monitor me? Conversations with patients who are • <F3 • Genotype3
- 9. • Under laws of Australia, UK and many other countries, individuals have the right to import a 3 month supply of medication for personal use • Generic Sofosbuvir, Ledipasvir & Daclatasvir studied
- 11. Results of Twitter Poll
- 12. Generic Therapy • Intellectual Property Laws vary across the globe • Egypt, India : Mass-produced copies of current HCV therapies • Use active ingredient of drugs • Buyers’ Clubs • However monitoring may be difficult to arrange in the UK if not prescribed here
- 13. Generics Approach for 2016 • Be honest with patients about potential risks and benefits • Ask your Trust about monitoring bloods policy • Argue for better accessibility for all
Notas del editor
- PegIFN, peginterferon; RBV, ribavirin; TVR, telaprevir. The lessons learned from the phase II telaprevir studies are shown on this slide. First, the optimal duration of telaprevir therapy was found to be 12 weeks, and it appeared that the optimal duration of the peginterferon and ribavirin backbone was 48 weeks. Second, ribavirin was found to be critically important to decrease breakthrough and relapse rates. Finally, activity was demonstrated in null responders, breakthrough patients, and relapsers.
- PegIFN, peginterferon; RBV, ribavirin; TVR, telaprevir. The lessons learned from the phase II telaprevir studies are shown on this slide. First, the optimal duration of telaprevir therapy was found to be 12 weeks, and it appeared that the optimal duration of the peginterferon and ribavirin backbone was 48 weeks. Second, ribavirin was found to be critically important to decrease breakthrough and relapse rates. Finally, activity was demonstrated in null responders, breakthrough patients, and relapsers.
- Generic versions of SOF/LED/DCV
- SVR 4 rates in generics c/w SVR12 rates in branded meds. Confidence intervals are narrow. Likely SVR4 will achieve SVR12