Generic antiretrovirals in Europe: a blessing or a curse?

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1 Generic antiretrovirals in Europe: a blessing or a curse? Ricardo Jorge Camacho 1 Molecular Biology Laboratory, Centro Hospitalar de Lisboa Ocidental 2 Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa

2 Adults and children estimated to be living with HIV/AIDS North America million Caribbean Latin America million Western Europe North Africa & Middle East Sub-Saharan Africa million Eastern Europe & Central Asia million East Asia & Pacific million South & South-East Asia million Australia & New Zealand Total: million

3 Generic Drugs and Quality Control 45 patients, intolerant to NNRTIs, receiving a Lopinavir/r generic drug as part of their first line regimen in South Africa 15 virologic failures (33,3%), with several PI drug resistance mutations

4 5 generic formulations of Lopinavir/r LPV: 79% - 104,6% RTV: 89% - 102% 3 generic formulations of Ritonavir RTV: 96,6% - 101,2%

5

6 Patent expiration dates for antiretrovirals

7 Go to the Web, they say... Saquinavir - Key Patent, SPC, and Data Exclusivity Expiry (44 Country Coverage) Date: Dec, 2010 Price: US$ 1, Publisher: GenericswebPty Ltd. Add to Basket QuickORDER Applicant Tradename Generic Name NDA Approval Date Type RLD Patent Number Product Substance Delist Req. Patent Expiration Exclusivity Expiration Bristol Myers Squibb Bristol Myers Squibb Bristol Myers Squibb Bristol Myers Squibb Bristol Myers Squibb REYATAZ REYATAZ REYATAZ REYATAZ REYATAZ atazanavir sulfate atazanavir sulfate atazanavir sulfate atazanavir sulfate atazanavir sulfate Jun 20, 2003 RX No <disabled> <disabled> Jun 20, 2003 RX No <disabled> <disabled> Jun 20, 2003 RX No <disabled> <disabled> Jun 20, 2003 RX No 5,849,911 Y Y <disabled> <disabled> Jun 20, 2003 RX No 6,087,383 Y Y <disabled> <disabled>

8 Patent Expiration Dates Zidovudine Stavudine Lamivudine Nevirapine Combivir Didanosine Indinavir Efavirenz Saquinavir Ritonavir Abacavir Trizivir Tenofovir Kivexa Raltegravir (Epzicom) Tipranavir Lopinavir/r Atripla Fosamprenavir Maraviroc Emtricitabine Truvada Etravirine Darunavir Atazanavir

9 The Blessing Branded Atripla Atripla: price per patient per year = US$ (1 = 1.3 US$)

10 Hospital Egas Moniz, Lisbon HIV-1 and HIV-2 patients (~8% of all HIV infected patients in Portugal) 2010: on antiretrovirals 150 patients starting ARV therapy each year Spending estimate for 2015:

11 A Blessing? A Curse? Branded Atripla Atripla: price per patient per year = US$ (1 = 1.3 US$)

12 3TC vs FTC: selection of M184I/V 51% p = % 11% (178 pts) (257 pts) (167 pts) (278 pts) A-G Marcelin et al, CROI 2011, abstract 617

13 p < p = ,6% 40% 14,3% (42) (40) (270)

14 M184I/V TDF+FTC

15 We can expect an increase of resistance Is there an acceptable level of resistance? Where will we draw the line between acceptable and unacceptable resistance? Can we accomodate it into guidelines? How will it affect resistance transmission?

16 Patent Expiration Dates Zidovudine Stavudine Lamivudine Nevirapine Combivir Didanosine Indinavir Efavirenz Saquinavir Ritonavir Abacavir Trizivir Tenofovir Kivexa Raltegravir (Epzicom) Tipranavir Lopinavir/r Atripla Fosamprenavir Maraviroc Emtricitabine Truvada Etravirine Darunavir Atazanavir

17 Gemini: Saquinavir/r vs Lopinavir/r 48 week, open-label, non-inferiority trial in drug-naïve patients % Viral Load < 50 copies/ml 63,5% 64,7% Boosted Saquinavir non-inferior to Lopinavir/r. Less Triglyceride elevations in Saquinavir/r arm

18 Saquinavir/r Virologic supression rates < 70% at 48 weeks not acceptable anymore Saquinavir/r was not tested for non-inferiority and safety against Atazanavir/r and Darunavir/r Pill burden and adherence?

19 A return to BID regimens? Higher pill burden? There s not a single randomized, prospective clinical trial proving superiority of BID vs OD regimens. Pill burden and adherence? AIDS Patient Care STDS Nov;23(11): An evidence-based review of treatment-related determinants of patients' nonadherence to HIV medications. Atkinson MJ, Petrozzino JJ. PRO-Spectus LLC, San Diego, California, USA. Less adherence when pill burden > 10 pills/day

20 A curse: return to higher toxicities? Events, n TDF+FTC+ EFV (n = 526) AZT+3TC+EFV (n = 519) HR (95% CI) P Value Total efficacy endpoints Confirmed virologic failure New AIDS event Death Events, n TDF+FTC+EFV AZT-3TC-EFV HR P Value Total safety endpoints < Initial dose modification < Grade 3-4 clinical events Grade 3-4 laboratory events < ACTG A5175/PEARLS: CROI 2011, Late Braker 149

21 STARTMRK: Virologic and Immunologic Efficacy at Week 48 Patients With HIV RNA < 50 copies/ml (%) ITT, NC = F Weeks RAL n = EFV n = Significantly shorter time to virologic response with RAL vs EFV (P <.001) Significantly greater CD4+ cell count increase with RAL vs EFV +189 vs +163 cells/mm 3 ; Δ: 26 cells/mm 3 (95% CI: 4-47) 86% 82% : 4 (95% CI: -2 to 10) P <.001 for noninferiority RAL EFV Lennox J, et al. ICAAC/IDSA Abstract 896a.

22 STARTMRK: Lipid Changes From Baseline to Week 48 Mean Change (mg/dl) Fewer patients initiated lipid-lowering therapy with RAL vs EFV (3 vs 11) P <.001 for all lipid parameters TC HDL-C LDL-C TG 4 patients in each arm increased lipid-lowering therapy RAL EFV Greater increases in all lipid parameters including HDL in EFV arm, no overall difference in TC:HDL ratio Mean Change (Ratio) 0-1 P =.292 TC:HDL Lennox J, et al. ICAAC/IDSA Abstract 896a.

23 So why isn t Raltegravir making its way to first-line regimens? Because it s BID? Because it s not co-formulated with other drugs? Because it s expensive? Because the toxicity of efavirenz is acceptable? How do we define acceptable or unacceptable toxicity?

24 Impact of generics for research and development of new HIV Drugs

25 Impact of generics for research and development of new HIV Drugs R&D costs are extremely high. Resistance is declining in Europe and USA. A reasonable return for development of new drugs can only be achieved if the drug makes its way to first-line or, at most, second-line therapy. With cheap generics like efavirenz or darunavir in the market, and residual multiresistance, is it worth to invest on new, expensive drugs? If the decision is not to invest, what will be the long term consequences for HIV infected patients?

26 You may ask questions, but probably I don't know the answers.

27

28 TDF TDF+FTC J Vercauteren, RJ Camacho et al: Retrovirology, :12 ( 1 February 2008 )

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