Access to current products and innovation for the future. WHO & UNAIDS Annual Consultation 31 Oct-1 Nov 2011

Transcription

1 Access to current products and innovation for the future WHO & UNAIDS Annual Consultation 31 Oct-1 Nov 2011

2 Specifications for resource-limited settings Affordable Effective (patients generally arrive with low immunity) Durable (limited treatment lines) Minimal side effects (to reduce monitoring requirements) Compatibility with other common medications (eg anti- TB drugs) Safety in pregnancy (women of childbearing age substantial proportion of treatment cohort) Available as fixed-dose combination (simplifies drug supply and promotes adherence)

3 Immediate and longer-term priorities Immediate Better access to optimal first-line TDF + 3TC/FTC + EFV the best choice Better access to effective second-line regimens Regimen alignment adults and kids Better access to viral load (+genotyping)

4 Quality and price: TDF/3TC/EFV only one PQ (generic) source TDF/FTC/EFV only one PQ generic source Lack of generic competition of TDF 3-in-1 FDC keep pricing high ie. Price of FDC > single or dual pills TDF-based first line regimen

5 Access beyond 1 st line Conservative figures for lowest generic (provided) price Middle income countries are not accessing these prices

6 Many countries not accessing lowest prices Middle Income Countries pay high prices TDF first line is priced over 1000 USD ppy, six times more than in countries where the generic versions can be accessed Brazil: USD 5,870ppy for raltegravir, USD 6,000ppy for darunavir/r Middle income countries increasingly excluded from differential prices ViiV and Merck ceased to offer standardized price discounts, negotiation on case-by-case Abbott excludes ritonavir 100 mg heat stable tablet from differential price policy in low and middle income countries Tibotec /Johnson &Johnson do not provide differential prices for darunavir and etravirine Untangling the web of price reduction (14 th edition), MSF, Geneva, 2011

7 Patent barriers: remaining options Use of TRIPS flexibilities: Strict patentability criteria (eg India section 3d); patent oppositions; compulsory licenses (eg Thailand, Brazil) Push back against TRIPS plus (eg EU-India FTA, TPP); Novartis Case against India; reluctance by countries to use flexibilities Public-health driven voluntary licenses Medicines Patent Pool: improved licensing terms over existing VL (NIH & Gilead licenses). Limitations of Gilead licenses include geographical scope, only Indian generics and API restrictions. MPP pro-public health actor brokering voluntary licensing schemes. Call on companies to enter pool 7

8 Lack of appropriate formulations Second line ARV FDCs for adults High pill burden (6 pills per day) for 2 nd line regimen Need for one pill once a day 2 nd line TDF/3TC/ATV/r Pediatric formulations adapted for resource poor settings Current LPV/r solution contains 42% alcohol and 15% propylene glycol LPV/r innovator solution requires cold chain until dispensing to patients and stability above 25 C is 1 day at patient level (Abbott s data) No PQ generic LPV/r solution nor dispersible tablet Paediatric RTV 25 mg oral solid formulation needed for double boosting of LPV during TB treatment

9 ARV supply issues experienced by MSF Pediatric products - problems in placing orders to manufacturers which reach the batch size. Pediatric products mostly 1-2 suppliers for FDCs, low volume thus long lead time and sometimes not produced TDF 3-in-1 FDC only one prequalified supplier, long lead time and relatively high price Registration of products in countries slow for new products Viral load still not available in most settings: need for second and third lines is under-estimated due to underdiagnosis

10 Viral Load products laboratory based Lab-based nucleic acid amplification MSF usually sends samples to a reference lab MSF have piloted the ExaVir Load HIV assay (Cavidi) in Myanmar The ELISA-based assay measures the activity of the reverse transcriptase enzyme as a proxy for viral load and does not need a molecular biology lab MSF have piloted the NucliSens EasyQ (R) HIV-1 viral load platform (biomerieux) in Malawi The NASBA technique specifically amplifies RNA; this means that viral load testing can be performed on DBS MSF are planning to pilot the Generic HIV-1 Viral Load assay (Biocentric) in Swaziland This open platform includes high quality, IVD approved reagents that are packaged into a kit The test may be performed on any real-time PCR machine An upstream automatic sample preparation instrument (e.g. the Nordiag Arrow) may be used Orders for all the reagents and instrumentation may be placed through Biocentric, who are also responsible for training and support

11 Viral Load products point of care Pipeline products No commercialised POC test available yet MSF have been involved in clinical trials for the SAMBA viral load test in Malawi and Uganda, and are planning to continue using this test Other pipeline tests include: Alere viral load test (similar to the PIMA) Liat Analyzer Cepheid viral load cartridge (to run on the GeneXpert ) Northwestern Global Health Foundation (1) p24 test for early infant diagnosis (2) viral load WAVE 80 EO-NAT HIV Rapid RNA Assay System Advanced Liquid Logic viral load test

12 CD4 Products point of care The Pima Analyzer Currently used by MSF Useful at POC and in mobile vehicles Limitation: cannot do CD4% Staff must be well-trained to take a capillary blood sample Dry reagents, no cold chain / storage CyFlow CD4 minipoc Not currently used by MSF Can be used for CD4% and other flow cytometric functions Dry reagents, no cold chain / storage Pipeline products Daktari CD4 Counter Zyomyx CD4 Counter Burnet Institute CD4 Counter

13 Immediate and longer-term priorities Longer term Role of Protease inhibitors in first line? Improved second line options: Darunavir optimization, price reduction and formulation as FDC. Clarify TB-drug interaction Dolutegravir as companion drug to Darunavir Explore alternative boosters Long acting formulation opportunities with ARVs such as RIL, GSK 744, CMX 157, DLG need to engage with communities on the target product profile of long-acting formulations

14 Conclusion: ART to support scale up ART has transformed HIV into a chronic disease Life-expectancy on ART in Africa is +27 additional years Successful scale up will mean health systems will need to cope with tens of millions of new patients Sustained scale up will require delinking ART dispensing from health services Self-management of ART This requires ART that is as simple as possible to take Forgiving first line, with minimal side-effects Patient-friendly formulations: FDCs LAF? Adapted diagnostic technologies and tools to be affordable Ensuring generic competition also for new products

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17 Overview (ref Maurine Murtagh for UNITAID)

18 Overview (ref Maurine Murtagh for UNITAID)