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Part 4: New HIV Treatment Pipeline
 

Part 4: New HIV Treatment Pipeline

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A presentation from the 2008 HIV Health and Treatments Update forum held in Sydney on 25 Nov 2008.

A presentation from the 2008 HIV Health and Treatments Update forum held in Sydney on 25 Nov 2008.

Part 4: a look at HIV drugs in development, presented by Bill Whittaker.

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    Part 4: New HIV Treatment Pipeline Part 4: New HIV Treatment Pipeline Presentation Transcript

        • The following slides and audio are taken from a public HIV health and treatments update forum held in Sydney, Australia on 25 November 2008. The slides and audio have been edited for presentation on the web.
        • The speaker is Bill Whittaker, NAPWA Health, Treatments and Research portfolio co-convenor.
        • For more presentations from this event, visit the sponsor organisations’ websites:
    • HIV Treatment and Health Update 25 November 2008 Part 4 New HIV treatment pipeline
    • HIV Antivirals in Use - 1994
      • Nucleoside RTI’s Non-Nucleoside RTI’s Protease Inhibitors
      • - AZT
      • - ddI
      • - d4T
      • - ddC
      • Nucleotide RTIs Other
      • - Hydroxyurea
      4 HIV antiviral drugs in use in 1994……………
    • HIV Antivirals in Use - 1998
      • Nucleoside RTI’s Non-Nucleoside RTI’s Protease Inhibitors
      • - AZT - Nevirapine - Indinavir
      • - 3TC - Delavirdine - Nelfinavir
      • - ddI - Efavirenz - Saquinavir &
      • - ddC Fortovase
      • - d4T - Ritonavir
      • - Abacavir - Amprenavir
      • Nucleotide RTIs Other
      • - Adefovir - Hydroxyurea
      16 HIV antiviral drugs in use in 1998……………
    • Most 1998 HIV Antivirals – By 2008 Withdrawn, Reformulated, Redesigned
      • Nucleoside RTI’s Non-Nucleoside RTI’s Protease Inhibitors
      • - AZT - Nevirapine - Indinavir
      • - 3TC - Delavirdine - Nelfinavir
      • - ddI - Efavirenz - Saquinavir #
      • - ddC Fortovase #
      • - d4T - Ritonavir *
      • - Abacavir - Amprenavir #
      • Nucleotide RTIs Other
      • - Adefovir - Hydroxyurea
      * Only for boosting other PIs # Reformulated/redesigned 10/16 antiviral drugs from 1998 either withdrawn, reformulated, redesigned, no longer commonly used in HIV………..
    • “ The white ones help my immune system but raise my blood pressure. The red ones lower my blood pressure but screw up my stomach. The green ones help my stomach but fuck with my immune system. Then these yellow ones simply ensure an attractive colour combination.”
    • 22 Antiviral Drugs available Nov 2008
      • Nucleoside RTIs
      • Abacavir (Ziagen)
      • Didanosine ddi (Videx-EC)
      • Emtricitabine FTC (Emtriva)
      • Lamivudine 3TC (Epivir)
      • Stavudine d4T (Zerit)
      • Zidovudine AZT (Retrovir)
      • Non Nucleoside RTIs
      • Efavirenz (Sustiva)
      • Nevirapine (Viramune)
      • Etravirine (Compassionate Access)
      • Nucleotide RTIs
      • Tenofovir (Viread)
      • Combination Pills
      • Trizivir (AZT + 3TC + Abacavir)
      • Kivexa (3TC + Abacavir)
      • Combivir (AZT + 3TC)
      • Truvada (FTC + TNF)
      • Atripla (FTC + TNF + Efavirenz)
      • Protease Inhibitors
      • Atazanavir (Reyataz)
      • Fosamprenavir (Lexiva)
      • Indinavir (Crixivan)
      • Lopinavir (Kaletra)
      • Nelfinavir (Viracept)
      • Ritonavir (Norvir)
      • Saquinavir ( Invirase)
      • Tipranavir (Aptivus)
      • Duranavir
      • Fusion Inhibitor
      • Fuzeon (T-20)
      • Integrase Inhibitor
      • Raltegravir
      • CCR5 Inhibitor
      • Maraviroc (Compassionate Access)
      • HIV drug resistance – treatment failure.
      • Toxicities and side effects have greatly improved – but they are still a problem for some.
      • More potent, longer acting drugs - more forgiving of missed doses.
      • We shouldn’t settle for lifelong daily treatment – not desirable and ? feasible. Good for pharma.
      New HIV Treatment Pipeline
      • Why do we need more HIV treatments?
      • HIV drug resistance – treatment failure.
      • Toxicities and side effects have greatly improved – but they are still a problem for some.
      • More potent, longer acting drugs - more forgiving of missed doses.
      • We shouldn’t settle for lifelong daily treatment – not desirable and ? feasible. Good for pharma.
      New HIV Treatment Pipeline
      • Why do we need more HIV treatments?
      • Treatment needs to be more than HIV antivirals – immune boosters and restorers.
      • The Cure
    • Gold Standard for New HIV Treatments
      • What doctors and community activists expect drug companies to deliver in their new drugs –
      • Potent and durable – work with other HIV drugs to drive the virus to undetectable and keep it there.
      • Low side effects & Convenient - once or twice daily.
      • Minimise toxicities - less potential for diabetes, cardiovascular problems, bone density, body fat changes, etc.
      • Must offer an advantage…. not just “copy cat” drugs.
      • Attack a variety of targets in the life cycle of HIV.
    • Nucleosides eg. 3TC Non-Nucleosides eg. Efavirenz Fusion eg. T20 Proteases eg. Kaletra CD4 T-Cell HIV antiviral drugs interrupt the making of new HIV virus Maturation Integrase eg. Raltegravir
    • HIV attaching & taking over CD4 T-cell
    • Newly made HIV going off to work
    • CD4 CCR5 HIV CD4 T cell surface
    • CCR5 blocker CD4 T cell surface CCR5
    • CCR5 blocker CCR5 CD4 T cell surface This HIV virus particle…….gives up and goes away…..
    • ARV Drugs in Early Research (pre-people)
      • In 2007 there are 86 that we know of, but no doubt more……..
      • Nucleoside RTI’s Non-Nucleoside RTI’s Protease Inhibitors
      • Integrase Inhibitors Maturation Inhibitors Entry Inhibitors Others
      11 13 7 13 5 20 17
    • 2008 Experimental HIV Antiviral Drugs Clinical Trials in People RTV like booster Gilead Phase II Enhancer GS 93502 RTV like booster Sequoia Phase I Enhancer SPI-452 Genentech Phase II CD4 TNX-355 Progenics Phase II CCR5 PRO 140 Phase I Aust. Schering Phase I CCR5 SCH532706 Schering Phase III CCR5 Vicriviroc Tobira Phase I CCR5 TBR-652 Gilead Phase II Integrase Elvitegravir Panacos Phase I/II Maturation Beviramat (PA-457) Sequoia Phase I/II Protease I SPI-256 Ardea Phase I/II Non-NRTI RDEA806 Tibotec/JJ Phase III Non-NRTI Rilpivirine (TMC-278) Pfizer Phase I/II Non-NRTI UK-453,061 Idenix Phase I/II Non-NRTI IDX899 Achillion Phase II NRTI Elvucitabine RFS Phase II NRTI Amdoxovir Australian Avexa Phase III NRTI Apricitabine Comment Pharma Clinical Trial progress Target Drug
    • HIV TREATMENT PIPELINE - 2007 Bevirimat Panacos TNX 355 Genentech GS1937 Gilead AVX754 Apricitabine Avexa Reverset Pharmasset Racivir Pharmasset TMC-278 Rilpivirine Tibotec BILR-355 BMS INCB9471 Incyte Corp ? Timelines for First Access KP-1461 Koronis Protease Inhibitors NNRTIs (Non Nukes) NRTIs (Nukes) Maturation inhibitor Integrase inhibitors Entry inhibitors 2012 2011 2010 2009 2008 Amdoxovir RFS Pharma GW 385 GSK
    • HIV TREATMENT PIPELINE - 2007 Bevirimat Panacos TNX 355 Genentech AVX754 Apricitabine Avexa TMC-278 Rilpivirine Tibotec ? Timelines for First Access 5/12 remain today Protease Inhibitors NNRTIs (Non Nukes) NRTIs (Nukes) Maturation inhibitor Integrase inhibitors Entry inhibitors 2012 2011 2010 2009 2008 Amdoxovir RFS Pharma
    • NEW ARV PIPELINE: Timelines for First Access Beviramat Panacos TNX 355 Genentech NO NEW INFO for some years SO DROP GS1937 Gilead AVX754 Apricitabine Avexa DISCONTINUED Reverset Pharmasset STALLED Racivir Pharmasset TMC-278 Rilpivirine Tibotec APPEARS DISCONTINUED BILR-355 BMS DISCONTINUED INCB9471 Incyte Corp Recently put on hold KP-1461 Koronis Protease Inhibitors NNRTIs (Non Nukes) NRTIs (Nukes) Maturation inhibitor Integrase inhibitors Entry inhibitors 2012 2011 2010 2009 2008 DISCONTINUED GW 640385 Brecanavir GSK
    • HIV TREATMENT PIPELINE - Now Beviramat Panacos TNX 355 Genentech AVX754 Apricitabine Avexa TMC-278 Rilpivirine Tibotec ? Timelines for First Access Vicriviroc Schering ACH-126 Elvucitabine Achillion IDX899 Idenix UK 453,061 Pfizer RDEA806 Ardea SCH 532706 Schering PRO 140 Progenics Protease Inhibitors NNRTIs (Non Nukes) NRTIs (Nukes) Maturation inhibitor Integrase inhibitors Entry inhibitors 2012 2011 2010 2009 2008 SPI-256 Sequoia Amdoxovir RFS Pharma
      • Failure of the most promising preventive vaccine (Merck).
      • Actually increased the risk of infection.
      • Prominent scientists says vaccine may never happen.
      • Major rethink – back to basics (March US meeting).
      • But knowing what doesn’t work can be helpful.
      • 10 years ago “ vaccine 10 years away ” – same message today?
      Vaccines - Pipeline Two kinds – prevent infection and help those already infected:
    • Immune based Treatments
      • Immune based treatments use the human immune system to provide a different way of treating HIV (defensive rather than offensive):
      • Three approaches –
        • therapies to boost the immune response to HIV itself (e.g., therapeutic vaccines).
        • therapies to improve immune function and/or overall health (e.g. cytokines and anti-inflammatory approaches).
        • gene therapies to alter the makeup of parts of the immune system to reduce or eliminate the harmful effects of HIV.
    • Immune based Treatments
      • Poor cousin of HIV research.
      • No immune based treatments for HIV approved in Australia, or elsewhere.
      • But research ongoing – information limited - few products close to advanced clinical trials.
      1 Source: Treatment Action Group NYC 08.08
      • A great variety of experimental and innovative approaches. 1
      • 18 HIV therapeutic vaccines. 1
      • 13 Gene Therapy, Cytokine, and Immunomodulator agents in early human trials. 1
          • Interleukin 2 (IL2) results soon.
    • The Pipeline – Summing it Up
      • The Pipeline - summing it up:
      • HIV antiviral treatment pipeline slower over next few years.
      • Unprecedented recent rush of new drugs – ebbs and flows .
      • Most antiviral drugs in the pipeline look like offering small, but important, improvements over existing approved drugs.
      • Immune-based therapy pipeline isn’t as advanced - but a lot going on - may lead to new directions for treatment and better understanding of HIV and the immune system.
      • Scientists and activists are thinking about how to make a quantum leap to the next level – curing HIV or disabling it.
      • Overall, HIV treatment pipeline suggests progress and hope .
    • Getting New Treatments to You
      • Now lots of experimental drugs and new pharmas – very strategic about lobbying for which new drugs.
      • Clinical Trials & Compassionate Access Schemes – equity.
      • Local and overseas negotiation – drug companies, researchers.
      • Pharmaceutical Advisory Boards = local & international.
      • Forging contact = clinicians, scientists, pharmas, O/S activists.
      • Tracking the drug regulatory and approval systems.
      • Many of our doctors are activists too!
      • Very time and resource demanding.
      New HIV treatments don’t just miraculously arrive on the pharmacy shelf………..
    • Getting New Treatments to You Activism is still necessary!!
    • Many of the topics in tonight’s update are covered in this Guide….. Pick up a copy at Positive Life, ACON or download from http://treataware.info/
        • For more presentations from this event, visit
        • www. napwa .org.au
        • or
        • www. acon .org.au