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New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW...

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New Directions in HIV Treatment: Implications for Antiretroviral Therapy Adherence Benjamin Young, MD PhD International Association of Providers of AIDS Care Washington, DC 1
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Page 1: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

New Directions in HIV Treatment: Implications for Antiretroviral Therapy Adherence

Benjamin Young, MD PhD International Association of Providers of AIDS Care

Washington, DC

1

Page 2: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

BENJAMIN YOUNG: DISCLOSURES

• Research support*:

– Gilead Sciences, Merck & Co., ViiV Healthcare

• Consultant or Advisory Board

– Bristol-Myers Squibb, Gilead Sciences, Merck & Co., ViiV Healthcare

• Speakers Bureau

– Merck & Co.

2 *APEX Research, Denver, CO

Page 3: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

HIV TREATMENT WORKS

• Preserves or restores immune function

• Prevents progression to AIDS

• Prevents serious illness and death

• Prevents transmission to others

3

Page 4: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

HIV TREATMENT WORKS

• Preserves or restores immune function

• Prevents progression to AIDS

• Prevents serious illness and death

• Prevents transmission to others

• In tested individuals able to adhere to care and treatment

4

Page 5: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

NEW DIRECTIONS IN HIV TREATMENT

• Treatment initiation guidelines

• Currently approved ART

• Emerging data on investigational drugs/approaches*

– For treatment

– For PrEP

*may include off-label or investigational medications

5

Page 6: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

NEW DIRECTIONS IN ART INITIATION

6

Page 7: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide
Page 8: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

ART ELIGIBILITY: HIVpolicywatch.org

8

Page 9: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

• Changing clinic appointments to every 6-12 months, and ART refills to every 3-6 months

• Predicts 50-75% increase in capacity at similar cost

• Improve retention/adherence?

NEW SERVICE DELIVERY MODELS: PEPFAR

9

Page 10: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

NEW DIRECTIONS IN ART

10

Page 11: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

DHHS ART GUIDELINES: 2016

11

Page 12: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

World Health Organization, November 2015

Page 13: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

13 Elliott, JAC 2016

Page 14: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS

• Tenofovir disoproxil fumarate (TDF) 300 mg

• Tenofovir alafenamide (TAF) 25 mg

• TAF: lower renal and bone adverse events

• New co-formulation potential:

– TDF/FTC + DRV/c

– TAF/FTC/DRV/c

14

Page 15: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

15 ENCORE Study Group, Lancet 2014

Page 16: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

FUTURE DIRECTIONS IN ART?

16

Page 17: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

TWO-DRUG ART?

17 Figueroa, EACS 2015

Page 18: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

INVESTIGATIONAL NNRTI: DORAVIRINE (DOR)

18

• 48 week, phase 2 dose-ranging study of TDF/FTC + EFV vs DOR

• Similar virologic activity and immunologic effect

• Statistically lower rates of drug-related AEs

• Phase 3 studies underway

Gatell, CROI2016

Page 19: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

LONG ACTING ART: RILPIVIRINE/CABOTEGRAVIR

19 Margolis, CROI 2016

Page 20: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

VERY LONG ACTING NRTI

20 Grobler, CROI2016

• EFdA- nucleoside RT

inhibitor

• Very long t1/2

• Effective viral reduction

dosed orally once—

weekly

• Parenteral PK supportive

of q6 month dosing

Page 21: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

NEW DIRECTIONS IN PrEP

21

Page 22: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

23 Grant, Lancet, 2014

Page 23: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

24 Baeten, NEJM 2016; CROI2016

Gulick, CROI2016

NEW APPROACHES TO PrEP:

Dapirivirine vaginal ring; Maraviroc

Page 24: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

25 Markowitz, CROI 2016

• Results suggestive of every 8 week dosing. Phase 3 program ongoing.

Page 25: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

NEW DIRECTIONS IN ART: ADHERENCE IMPLICATIONS

• Universal access to ART should improve continuum

• Improvements in currently approved ART

– EFV400, TAF, INSTIs

• Investigational medications and strategies

– Dual drug therapy with DTG

– LA oral and injectable meds for Tx and PrEP

– Vaginal ring for PrEP

• Critical need to evaluate adherence and continuum implications

26

Page 26: New Directions in HIV Treatment€¦ · Elliott, JAC 2016 . TENOFOVIR ALAFENAMIDE POTENTIAL NEW COFORMULATIONS •Tenofovir disoproxil fumarate (TDF) 300 mg •Tenofovir alafenamide

Thank you!

Gracias!

Mercî!

Asanti sana!

Спасибо!

Obrigado!

谢谢

[email protected]

Dr. Ben Young

27

BenYoungMD


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