TasP Workshop. Prac-cal Aspects of Drug Selec-on and Supply Panel Discussion 2 May 2014

Transcription

1 TasP Workshop Prac-cal Aspects of Drug Selec-on and Supply Panel Discussion 2 May 2014

2 CHOICE OF ARV REGIMEN

3 Adults, including pregnant women and people with TB and HBV co- infec-on ADULTS WHO Interna9onal Guidelines Preferred 1st line Alternate regimen Preferred 2nd line Alternate 2nd Salvage GOALS OF ART: Durable suppression of HIV viral load Restora-on of immune func-on Improvement in quality of life Preven-on of drug resistance Preven-on of HIV transmission TDF+FTC (or 3TC)+EFV as FDC TDF+3TC (or FTC) +NVP AZT+3TC+EFV (or NVP) AZT+3TC+LPV/r AZT+3TC+ATV/r TDF+3TC+ATV/r TDF+3TC+LPV/3 Ral+DRV+ Etravirine TDF+FTC+EFV TDF+FTC+ATV/r or DRV/r TDF+FTC+Ral ABC+3TC+EFV (or Rilpivirine) ABC+3TC+ATV/r (or DRV/r or LPV/r) ABC+3TC+Ral Source: DHHS Dec 2007 TDF+FTC+Elvitegravir/Cobicistat new regimen based on resistance tes-ng

4 Choosing ARVs Desired proper-es Potency Simplicity low pill burden (FDCs), no diet restric-on, heat- stable Tolerability/Safety metabolic disease, pregnancy Durability high gene-c barrier no drug interac-ons (Tb, malaria, metabolic disease) Affordability

5 Looking in the pipeline Tenofovir alafenamide (TAF) Precursor drug to tenofovir Extremely effec-ve with fewer side effects?lower price as less ac-ve pharmaceu-cal ingredient needed Once- daily regimens Rilpivirine/DRV/r (CROI 2014 #507 and 508) Elvitegravir/cobicistat/FCT/TAF LA nano formula-on to improve bioavailability: GSK 744 (related to dolutegravir, INI) oral or IM Lipid nano par-cles bound to LPV/RTV/TNF

6 The treatment -me bomb PREDICTING DEMAND

7 Predic-ng demand Expansion of access Earlier treatment ini-a-on Treatment to reduce transmission Forecas-ng volume of HIV- infected persons to be treated: up to 2016: 15 Million Up to 2030: 55 Million

8 Actual and projected numbers of people receiving an9retroviral therapy in low- and middle- income countries, and by WHO Region, Source: 2013 Global AIDS Response Progress Repor-ng (WHO/UNICEF/UNAIDS). 21 Mill Target met for only 10% of children 7.5 Mill 12 Mill

9 Adults and children eligible for and receiving an9retroviral therapy, in low- and middle- income countries, Source: 2013 Global AIDS Response Repor-ng (WHO/UNICEF/UNAIDS) and 2012 UNAIDS/WHO es-mates.

10 Friend or foe? ROLE OF GENERICS

11 ARV Price Reduc-on In a decade ( ) the price for ARVs decreased by 99% Produc-on of generics for a frac-on of the price demanded by pharmaceu-cal industry Advocacy role of NGOs e.g. Medecins Sans Fron-eres (MSF) and Clinton Health Access Ini-a-ve (CHAI) Generic ARVs are now the main drugs used in the scale up of ART in resource limited segngs Surveillance to monitor quality and produc-on of generic medica-on Bulk purchase agreements (UNITAID) Pharmaceu-cal company access approach Voluntary licences Tiered pricing system Renewed advocacy to assure affordable prices and availability for new drugs in the development pipeline

12 Price comparison of 1 st, 2 nd and 3 rd line regimens source: MSF 2016

13 INSURING RELIABLE SUPPLY

14 Insuring reliable supply Sustained delivery of ART to increasing number of people requires robust supply chains and efficient monitoring Early Warning Indicators of HIV Drug Resistance provide informa-on on program/clinic performance EWI on Pharmacy Stock outs number of months in the designated year in which there were no stock- out days of any ARV drug rou-nely used at the site

15 50- Country Summary Report on EWIs Source: Bennek CID 2012 Pharmacy stock- out Reported by only 6 countries Dispensing Prac-ce 100% LTF <20% Reten-on On 1 st line >70% One- -me pill pick- up >90% ARV supply con-nuity 100% Viral Suppression >70%

16 DRUG RESISTANCE

17 ARV Drug Resistance Drug resistance is a major obstacle to achieve and maintain successful ART programs. 24% of pa-ents receiving first- line ART in sub- Saharan Africa have virological failure within 12 months of ini-a-on of first- line ART; >70% with DRM (systema-c review of 89 studies comprising of > pa-ents (Barth, Lancet Infec-ous Diseases, 2010) Significant increase in prevalence of primary drug resistance over -me of ART roll out Driven by NNRTI resistance in studies from East and Southern Africa

18 Prevalence of TDR by -me since ART rollout source: Gupta Lancet 2012 East Africa Annual rate of increase: 29% (15-45; p=0.0001) Southern Africa Annual rate of increase: 14% (0-29; p=0.054) West and Central Africa Annual rate of increase: 3% (9-16; p=0.618) La-n America and Caribbean

19 Drug resistance Factors contribu-ng to emergence of drug resistance Pa-ent characteris-cs Poor pa-ent educa-on and trust Weak social support Incomplete adherence ARV regimen Substandard regimens Drug interac-ons e.g. rifampicin Provider/program characterisitcs Weak ART program func-oning Lack of viral load monitoring Drug stock outs

20 Discussion Effec-ve, affordable and simple ARV regimens are indispensible for the successful and sustainability of ART programs Uninterrupted supply, correct prescrip-on, dispensing, and pa-ent adherence are mandatory to sustain the HIV care con-nuum Iden-fying and addressing gaps and deficiencies in health care systems by monitoring performance and improving efficiency on individual clinic level is cri-cal

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