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ARVs and ART – looking to the futureSharon R LewinProfessor and Head, Department of Infectious Diseases, Monash University and Alfred HospitalCo-head, Centre for Biomedical Research, Burnet Institute, Melbourne, Australia 7th IAS Conference on Pathogenesis, Treatment and Prevention, Kuala Lumpur, 30th June – 3rd July, 2013

Arv and art looking to the future
ARV and ART: looking to the future

  • Better antiretrovirals

    • Reduce cost

    • Reduce toxicity

    • Enhance durability of control

  • Reduce long term morbidity

  • The very distant future

Cheaper and better antiretrovirals

cheaper and better antiretrovirals

Strategies to reduce cost of current arvs
Strategies to reduce cost of current ARVs

  • Optimising the active pharmaceutical ingredient (API)

    • Optimise material sourcing

    • Change in manufacturing process

    • Improve bioavailability

  • Pharmaco-enhancement

  • Extension of shelf-life

  • Reduce dose

Crawford et al., Lancet Infect Dis 2012; 12:550; Conference on Antiretroviral Dose Optimisation (CADO), 2010

New source of raw material mg tert butoxide reduces cost of tdf
New source of raw material Mg tert-butoxide reduces cost of TDF

Similar strategies currently being evaluated for

efavirenz, ATZ/r, DRV/r

Crawford et al., Lancet Infect Dis 2012; 12:550

New arvs in development
New ARVs in development cost

Gulick, 20th CROI, Atlanta, GA, March 2013

Tenofovir alenofenamide taf reduced renal toxicity and cost

100 cost






% HIV-1 RNA <50 c/mL












Time (Weeks)


Tenofovir alenofenamide (TAF): reduced renal toxicity and cost

TDF/FTC/EVG/c 90% (n=58)

TAF/FTC/EVG/c 88% (n=112)

  • Change in serum creatinine at Week 24

    • TAF +0.07 mg/dL

    • TDF +0.12 mg/dL (p=0.02)

Rx-naïve, VL >5000, CD4 >50 (N=170)

New technologies for delivery of arvs
New technologies for delivery of ARVs cost

  • Nanotechnology

    • Efavirenz 300mg

    • Pediatric LPV/r in development

  • Injectables, implants, slow release

    • GSK744 + rilpivarine LA

    • GSK744 + 2NRTI (Latte study)

    • Vaginal rings e.g., dapivirine / maraviroc

  • Multipurpose prevention technologies

    • HIV + STI + pregnancy

Long and short term priorities to improve arvs
Long and short term priorities to improve ARVs cost

  • First-line

    • fixed-dose combination regimens that are equally or more potent and more durable and affordable than TDF/XTC/EFV

  • Post Treatment –failure

    • fixed dose boosted, dose-optimized darunavir in replacing atazanavir or lopinavir as the protease inhibitor of choice

    • A one pill once daily second-line regimen.

    • Studies of reduced-dose darunavir/ritonavir (DRV/r),

  • Enhancing Trial Participant Criteria

    • including girls and women of reproductive age, TB co-infection, and comorbidities (such as hypertension).

  • Longer Term Research Priorities

    • oral and injectable long-acting drugs (including GSK744 and TMC278) as well as nano-formulations and implantable devices.

CADO2 report, South Africa, April 2013

Reduce long term morbidity

reduce long term costmorbidity

Increased age related complications on art
Increased age-related complications on ART cost

Mean AMI events per

1000 person years

Increased risk of AMI in HIV compared to HIV uninfected

HR = 1.48 (CI = 1.27 – 1.72)

Further increase HR if CD4<200 or HIV RNA>500

N=82,459; Veterans Ageing Cohort Study Virtual Cohort

Frieberg et al., JAMA Internal Med 2013

Hiv and aging in africa
HIV and aging in Africa cost

In 2040, the number of persons over 50 years of age

living with HIV is expected to be 9 million

Mills et al., N Engl J Med 2012; 366:14

Etiology of non aids related events
Etiology of non-AIDS-related events cost







inflammation(immune activation)

(e.g. smoking)

Non-AIDS-related events are more common in HIV disease, even after adjustment for age, cART exposure and traditional risk factors

Deeks SG, Phillips AN.Br Med J 2009;338:a3172

Prevention of non aids events needs a different model of care
Prevention of non AIDS events needs a different model of care

  • Lifestyle modifications

    • Reduce smoking, healthy diet, exercise

  • Reduce modifiable risk factors

    • Assessment of blood pressure, glucose and lipids

  • Counselling and screening for common cancers

  • Enhance CD4 recovery and reduce inflammation

Hiv cure is rare and possible but a very long term goal
HIV cure is rare and possible – but a very long term goal care

The Berlin Patient


The Mississippi baby

Acknowledgements care

The Alfred Hospital, Melbourne

Julian Elliott

Jennifer Hoy

Edwina Wright


Steve Deeks

Diane Havlir

Trip Gulich

Judith Currier

Andrew Ball

Adeeba Kamarulzaman