1. Review experiences of global ARV shortages Clarisse Morris, MA February 2006

2. Slide 2 Issues in global ARV shortages 1.Increase in the number of patients on treatment. 2.Change in the recommended treatment guidelines. 3.Increase in the number of patients on 2nd line regimens.

3. Slide 3 1.Increase in the number of patients on treatment GFATM aims to finance treatment for 1.8 million people by 2008. PEPFAR aims to have 2 million people on treatment by 2009. This scale up puts pressure on the production capacity of: –ARV manufacturers; –ARV raw material manufacturers.

4. Slide 4 Recent ARV shortages Zerit (Stavudine-d4T) by Bristol Myers Squibb; All GlaxoSmithKline ARVs containing Zidovudine (ZDV); Epivir (Lamivudine-3TC) by GSK; Stockrin (Efavirenz-EFV) by Merck.

5. Slide 5 Recent ARV shortages (cont’d) Generics (temporarily) removed from WHO prequalification list

6. Slide 6 2.Change in recommended treatment guidelines Last WHO ARV treatment guidelines date from 2003. Revision is scheduled for 2006. Possibly 3 drugs will be added to the 1st line regimen. An increased demand for these drugs could fuel shortages.

7. Slide 7 3.Increase in the number of patients on 2nd line regimens Needed for 500.000 people worldwide within the next 2 years. Costs are more than 10x the 1st line treatment price. Clinton HIV/AIDS Initiative’s 2006 aim: lowering prices of 2nd line drugs. Lower prices mean more people can be treated. Increased demand could cause shortages.

8. Slide 8 References Demand for two AIDS treatments could soon exceed supply by Paul Davies, Wall Street Journal, 2005. http://www.essentialdrugs.org/edrug/archive/200503/msg00034.php Medicine procurement of ARVs and other essentiel medicines in the U.S. Global AIDS programs by Sharonann Lynch, Health Gap, November 2005. http://www.healthgap.org/press_releases/05/1105_PWATCH_HGAP_BP_PROC.pdf Clinton HIV/AIDS Foundation Press Release: New agreements to lower prices of HIV/AIDS rapid tests and 2nd line drugs, January 2006. http://www.clintonfoundation.org/011206-nr-cf-hs-ai-isr-ind-chn-zaf-bra-pr-new- agreements-to-lower-prices-of-hiv-aids-rapid-tests-and-second-line-drugs.htm Update on China and India and Access to Medicines by Cheri Grace, DFID, November 2005. http://www.dfidhealthrc.org/what_new/Final%20India%20China%20Report.pdf