HIV Treatment 101 C. Ryan Tomlin, Pharm.D., BCPS, AAHIVP - PowerPoint Presentation

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HIV Treatment 101 C. Ryan Tomlin, Pharm.D., BCPS, AAHIVP - PPT Presentation

Clinical Pharmacist HIV Medicine Outline What is HIV Common Labs Life Cycle and Medication Targets Building an HIV regimen HIV Guidelines When to start treatment What medications to start ID: 933362

hiv nrti start medications nrti hiv medications start therapy cd4 medication inhibitor 350 treatment resistance integrase drug regimen tenofovir

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Slide1

HIV Treatment 101

C. Ryan Tomlin, Pharm.D., BCPS, AAHIVP

Clinical Pharmacist – HIV Medicine

Slide2

Outline

What is HIV?

Common Labs

Life Cycle and Medication TargetsBuilding an HIV regimenHIV GuidelinesWhen to start treatmentWhat medications to startWhen to change therapy

Slide3

What is HIV?

uman – Only found in humans

Immunodeficiency – Weakens immune system by destroying CD4 cellsVirus – Reproduces by taking over a host cell

Slide4

Common HIV Labs

Viral Load

How much HIV is in the blood

Lower the betterCD4 CountHow strong the immune system isHigher the betterGenotypeHas HIV found ways to avoid certain medications?

Resistance test

Slide5

HIV Time Course

Slide6

Goals of Therapy

Increase the CD4

Above 200, preferably above 500

Decrease the VLNon-detectableImprove quality of lifeReduce secondary HIV related diseaseReduce transmission (Undetectable =

Untransmittable

)

Slide7

HIV Life Cycle

Slide8

NRTIs

NNTRIs

PIs

Single Tablet

Regimens

Entry/Fusion Inhibitors

Combivir

Edurant

Aptivus

Atripla

Fuzeon

Descovy

Intelence

Crixivan

Biktarvy

Rukobia

®Emtriva®Pifeltro®Evotaz®Complera®Selzentry®Epivir®Rescriptor®Invirase®Delstrigo®Trogarzo®Epzicom®Sustiva®Kaletra®Dovato®Retrovir®Viramune®Lexiva®Genvoya®Trizivir®Norvir®Juluca®Truvada®INSTIsPrezcobix®Odefsey®Videx®Isentress®Prezista®Stribild®Viread®Tivicay®Reyataz®Symtuza®Zerit®Vitekta®Viracept®Triumeq®Ziagen®

FDA Approved Antiretrovirals

Slide9

Building an HIV Regimen for a New Patient

Three medications from at least 2 different classes (usually…)

Never mono therapy

NRTIs are the only class we routinely use more than 1 at a timeRitonavir and Cobicistat do not countNumber of medications does not have to match the number of pills

Slide10

Example Single Tablet Regimens

Biktarvy

– 2018

Tenofovir alafenamide/Emtricitabine/Bictegravir

NRTI/NRTI/INSTI

Symtuza

– 2018

Tenofovir

alafenamide

Emtricitabine

Darunavir

Cobicistat

NRTI/NRTI/PI/Booster

Slide11

The Two Drug Rule Exceptions

Juluca

– 2017

Rilpivirine/DolutegravirNNRTI/INSTIOnly used in someone stable on another regimen for 6 monthsDovato

– 2019

Dolutegravir

/Lamivudine

INSTI/NRTI

Slide12

Simpler Regimens Over Time

Regimen

Dosing

Pill Burden

1996:

q8h: 10 pills/d

/ /

1998

q12h: 5 pills/d

2002

q12h: 3 pills/d

2003

qd : 3 pills/d

2004

qd: 2 pills/d

2006

qd: 1 pill/d

Slide13

Available Guidelines

US DHHS : Department of Health and Human Services

IAS-USA : International AIDS Society

BHIVA : British HIV AssociationEACS: European AIDS Clinical SocietyWHO: World Health Organization

Slide14

What the Guidelines Address

Laboratory testing

When to start treatment

What medications to startWhen to change therapyTreatment of special populationsTreating co-infected patientsMedication side effects and drug interactions

Slide15

When to Start Therapy

What to Start

When to Change Therapy

Slide16

Treatment Initiation Over Time

1998

2001

2002

2004

2007

2009

2012

CD4 Count

Treat: <500

Treat: <200

Offer:

<350

Indiv.

>350

Treat: <200

Offer:

<350

Indiv.

>350

Treat: <200

Offer:

<350

Indiv.>350Treat:

<350

Indiv.>350Treat:<350Rec:<500Indiv.>500Treat everyone<350 (AI)<500 (AII)>500 (BIII)VL>20,000>55,000>100,000Other factorsPregnantHBVHIVANPregnantHBVHIVANPregnantHBVHIVANHigh risk of transmitting16Start EveryoneA1 – Strong Recommendation

Slide17

START Study

International Study

215 sites in 35 countries

4,685 patients with CD4 counts above 500 enrolledHalf started medications right awayHalf waited till CD4 dropped below 350

http://www.niaid.nih.gov/news/newsreleases/2015/Pages/START.aspx

Slide18

START Study Results

http://www.niaid.nih.gov/news/newsreleases/2015/Pages/START.aspx

Slide19

Benefits of Early Treatment

Maintain higher CD4 count to prevent damage to the immune system

Decrease risk of HIV associated complications

Opportunistic infectionsUnderlying inflammationDecrease risk of transmissionUndetectable = Untransmittable

Slide20

Increase in CD4 Count

Gras L et al.

J Acquir Immune Defic Syndr

. 2007;45(2):183-192.

Median CD4 Response in Patients ≥50 Years at the Start of ART

Years from Starting ART

1100

1000

900

800

700

600

500

400

300

200

100

Mean CD4 Cell Count (cells/mm

)

<50 cells/mm

50-200 cells/mm

200-350 cells/mm

350-500 cells/mm

≥500 cells/mm

Control (male, <50 years at start of ART)

≥ 50 years at start of ART

Slide21

When to Start Therapy

What to Start

When to Change Therapy

Slide22

Building An HIV Regimen

2 NRTIs

1 NNRTI

1 Protease Inhibitor

1 Integrase Inhibitor

Slide23

Example Regimens

Abacavir

Lamivudine

Dolutegravir

Triumeq

NRTI

Integrase Inhibitor

Tenofovir

Emtricitabine

Darunavir

Descovy

NRTI

Protease Inhibitor

Cobicistat

Prezcobix

Booster

Slide24

First Line Regimens For Most People

Tenofovir

Emtricitabine

Raltegravir

NRTI

Integrase Inhibitor

Tenofovir

Emtricitabine

Dolutegravir

NRTI

Integrase Inhibitor

Abacavir

Lamivudine

Dolutegravir

NRTI

Integrase Inhibitor

Tenofovir

Emtricitabine

Bictegravir

NRTI

NRTIIntegrase InhibitorTruvada®/Descovy® + Isentress®Truvada®/Descovy® + Tivicay®Biktarvy®Triumeq®Lamivudine

Dolutegravir

NRTI

Integrase Inhibitor

Dovato

Slide25

The Rational For

Unboosted

Integrase Inhibitors

Fewer drug interactions than NNRTIs, PIs and ElvitegravirNo food requirementGood tolerabilityReduce the HIV viral load very quickly

The differences between recommended regimens is getting more and more subtle…

Slide26

Treatment Naïve – Treatment Selection Factors

Baseline resistance testing and viral load

Patient anticipated adherence

Other health conditionsKidney disease, heart diseasePregnancy

Hepatitis co-infections

Side Effects

Drug interactions

Patient’s daily schedule and meal times

Slide27

Treatment Experienced

Resistance testing

Antiretroviral medication history

Side effect historyAllergiesAdherence/possible resistanceAll treatment naïve factors

Slide28

Building an HIV Regimen for a New Patient

Three medications from at least 2 different classes (usually…)

Never mono therapy

NRTIs are the only class we routinely use more than 1 at a timeRitonavir and Cobicistat do not countTwo exceptions to the three medication rule –

Juluca

Dovato

Number of medications does not have to match the number of pills

Slide29

Building A Salvage Regimen

Three medications, each from a different class

Medications selected based on viral resistance

Can still use more than 1 NRTICan have more than 3 medications if there are not enough fully active medications left

Medication 1

Partial resistance

Medication 2

Partial resistance

Medication 3

No resistance

Medication 4

No resistance

= 3

Active

Medications

Slide30

Appropriate or Not?

Question #1

Tenofovir

Emtricitabine

Elvitegravir

Stribild

NRTI

Integrase Inhibitor

Cobicistat

Booster

Yes

Probably Not

Slide31

Appropriate or Not?

Question #2

Yes

Probably Not

Tenofovir

Darunavir

Viread

NRTI

Protease Inhibitor

Cobicistat

Prezcobix

Booster

Only 2 Active Medications

Slide32

Appropriate or Not?

Question #3

Yes

Probably Not

Abacavir

Lamivudine

Zidovudine

Trizivir

NRTI

Only 1 Class

Slide33

Appropriate or Not?

Question #4

Juluca

Rilpivirine

Dolutegravir

NNRTI

Integrase Inhibitor

Yes

Probably Not

Two Drug-Rule Exception

Slide34

When to Start Therapy

What to Start

When to Change Therapy

Slide35

Reason For Therapy Changes

Viral Failure

Side Effects

Drug InteractionsComorbiditiesReduce Pill BurdenPregnancyCost/Insurance

Slide36

Viral Failure

Possible Causes

Suboptimal adherence

Pharmacokinetic issuesPossible drug resistanceNew regimen selection is based on cause of regimen failure and remaining antiretroviral options

Slide37

Can I Go Back To My Old Regimen?

Resistance/Viral Failure

Side Effects, Drug Interactions, ComorbiditiesDepends on the clinical picturePill burden, Pregnancy, Cost/InsuranceLikely

Slide38

Interruptions in Therapy

Stop all antiretrovirals at once

Spacing them out only leads to resistance

In patients with hepatitis B, treatment interruptions can lead to a hepatitis flareAlways refer patient back to their medication provider

Slide39

Drug Holidays

If a patient's immune system is strong is it possible to stop medication for a period of time to decrease medication side effects?

Short answer: No

Slide40

SMART Study

5,472 patients enrolled

Half took medications continuously

Half took medications till their CD4 count was >350, then stopped till <250ResultsThose who took medication holidays were 2.5x more like to have a clinical event or death

Engl

J Med

. 2006;355:2283-96.

Slide41

Summary

All patient should be offered medications regardless of CD4 count

Initial treatment regimens should have 2 or 3 active medications

Regimens should be designed to fit the patientInterruptions in therapy should be avoided

Slide42

HIV Treatment 101

C. Ryan Tomlin, Pharm.D., BCPS, AAHIVP

Clinical Pharmacist – HIV Medicine