edward cachay md, mas associate professor of medicine ucsd-owen clinic copyright © edward cachay...

Edward Cachay MD, MASAssociate Professor of Medicine

UCSD-Owen Clinic

Copyright © Edward Cachay MD, MAS.

Agenda:1. Understanding main barriers to care for hepatitis C (HCV) therapy among HIV patients : sharing our clinic approach.2. Review of new concepts on HCV therapy focusing on applicability of concepts (rather than individual clinical trial data review)3. Interactive cases with brief description of our observations regarding safety of HCV triple therapy among HIV patients


How do you treat HCV in your HIV clinic?

1. Patients are referred to hepatology clinic.2. Patients are referred to other type of sub-specialty clinic such as infectious disease clinic.3. Any HIV provider treats HCV.4. There is an integrated sub-specialty clinic co-located in your main HIV clinic. 5. Currently hepatology but you are implementing your own HIV/HCV clinic.


12 Jan 2012: Nick came to the UCSD Owen HIV/HCV clinicNick is a 32yo caucasian HIV-infected MSM who was

referred by his primary provider for HCV consideration. Nick was diagnosed with HIV 9 months ago while

hospitalized in the critical care unit due to congestive heart failure and myocardial infarction suspected induced by intravenous methamphetamine use.

At diagnosis: CD4: 420, HIV VL: 755, 435. HAART started 2 months prior to his HCV referral date: Truvada + Darunavir/norvir (once a day)

Nick has history of bipolar disorder, he acknowledged a prior suicidal attempt at age 21 while ‘under the influence’.

Cardiac: Carvelidol + Metoprolol + Lasix + aldactonePsych meds: Abilify + valproic acid


Nick’s available results:

HCV genotype 3HCV RNA 9’000,000Nick has Ryan White insurance, thus IL-28

can’t be obtained. Grade I transaminitis Nick is upset because he thought he had a

cardiology appointmentNick states that his liver is fine and does not

bother him at all.


What would be you your next step managing Nick’s hepatitis C?

1. Explain Nick the need of a liver biopsy to assess how urgent he needs or not HCV therapy.2. Tell Nick that he is welcome to reschedule a follow-up appointment any time when he feels ready for HCV treatment. 3. Commend Nick for coming to his health appointment, brief HCV health education and offer a follow-up appointment in 2-4 weeks. 4. Tell Nick that his medical condition is too fragile and it would be best to wait ~3-years until new HCV interferon sparing treatment options are available.


Healthy LiverHealthy Liver

Time

Cirrhotic Cirrhotic Cancer of the Cancer of the

Liver Liver


Acute Injury

Mild ModerateSevere

Chronic Injury Cirrhosis * ESLD

Healthy Liver

A B C

25 – 40 years 2 – 10 years

* ESLD = End Stage Liver DiseaseCopyright © Edward Cachay MD, MAS.


Liver fibrosis progress faster in HIV/HCV than patients in

patients infected with HCV without HIV

Ann Intern Med. 2013;158(9):658-666.

Persons with HIV had liver fibrosis measurements equal to those of persons without HIV, who were, on average, 9.2 years older

Is not just a liver issue: REVEAL-HCV

Lee et al. J Infect Dis 2012; 206: 469-77.

2.8

1.5

1.3

1.4

5.4

21.6

12.5

1.9

//

All causes death

Liver-related

Liver cancer

Cirrhosis

Extrahepatic

Cancers*

Cardiovascular

Kidney

Adjusted hazard ratio

HCV Ab-pos vs HCV Ab-neg

- 23,820 adults followed for a mean of 16.2 years- 1095 HCV Ab+ (4%)- 69% of HCV Ab+ were HCV-RNA pos- 2394 deaths during the study period

*esophagus, prostate & thyroid


What proportion of HIV patients with known HCV are treated in the United States at the end of 2011?1. 20%2. 25%3. 50%4. 5%5. 75%


100% patients with known HIV/HCV

never treatedTreated

Cachay et al. AIDS Res Ther 2011, 8:e29

~20%


100% patient with known HIV/HCV

never treated25% adverse events10% lost to follow-up35% sustained viral response30% virological failure


Jan 2011 HRSA recommendations:1. Any newly diagnosed patient with HIV should be tested for HCV2. Annual HCV testing with HCV EIA If HCV ab negative given unreliable history regarding risk factors for HCV


From 1947 HIV-infected patients included, with a median follow-up time of 107 months (IQR: 57–156), only 23% received treatment for HCV (456 patients)

Grint D et al. 2012. [Abstract 0243]. Posters and abstracts of the 11th International Congress on Drug Therapy in HIV Infection, Glasgow .

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00

Inci

den

ce p

er

100

PY

FU

1998 2000

2002

2004

2006

2008

2010

Incidence rate of uptake of HCV treatment in EuroSIDA by region

South

North

West

East C

East


Patient Provider

Medical system

Limited testing centers

Low № providers confident

delivering HCV treatment

Too complex perception:A.PatientsB.Management

Depend on sub-specialty

clinic

Too much paper work:A.Patient access B.Underinsured

Low reimbursement incentive

Adapted from Grebely et al. 2013. JID; 207 (Suppl 1)


Illegal substance use

Neuropsychiatry disease

Alcohol dependence

Poverty

Cachay et al. AIDS Res Ther 2011, 8:e29Copyright © Edward Cachay MD, MAS.

Reason Patients, n (%)

Medical HIV identified as priority Minimal liver fibrosis Contraindicated comorbidity Too late (ESLD)

15 (22) 12 (18) 1 (1) 1 (1)

Psychiatric Ongoing issue Needle phobia

4 (6) 1 (1)

Patient related Patient declined Lost to follow-up Never show to hepatitis clinic Unstable housing predicted poor adherence

8 (12) 8 (12) 5 (7) 2 (2) 1 ( 1)

Substance use Alcohol Illicit drug use

7 (10)3 (4)Can J Gastroenterol Vol 22, No 22,

Feb 2008


Reason Patients, n (%)

Medical HIV identified as priority Minimal liver fibrosis Contraindicated comorbidity Too late (ESLD)

15 (22) 12 (18) 1 (1) 1 (1)

Psychiatric Ongoing issue Needle phobia

4 (6) 1 (1)

Patient related Patient declined Lost to follow-up Never show to hepatitis clinic Unstable housing predicted poor adherence

8 (12) 8 (12) 5 (7) 2 (2) 1 ( 1)

Substance use Alcohol Illicit drug use

7 (10)3 (4)

Can J Gastroenterol Vol 22, No 22, Feb 2008

‘’1 in 2 patients are not treated due to

ongoing barriers to care”


Strategies proven successful for enhancing HCV evaluation, adherence and treatment Primary and specialty cared-based

integrated clinicsHIV primary care supported by pharmacistCommunity base telehealth medicineNurse-led educationDirect observed therapyPeer-support groups and workers

Adapted from Grebely et al. J nfect Dis. 2013;207 Suppl 1:S19-25


Peg-IFN + RBV

Peg-IFN + RBV + DAA

DAA combination

20162011 20132012 2014 20152010

Treatment complexity

HIV primary care/ID clinics to treat HCV

Adapted from Grebely et al. J nfect Dis. 2013;207 Suppl 1:S19-25Copyright © Edward Cachay MD, MAS.

HIV provide

r

Pharmacist

Psychiatrist

Substance

counselor

UCSD-OwenHepatitis

Clinic


HIV

con

trol

BA

RR

IER

S

LIV

ER

statu

s

Co-m

orb

iditie

s

The staging table of HCV among HIV-infected patients


HIV

con

trol

BA

RR

IER

S

LIV

ER

statu

s

Co-m

orb

iditie

s32yo meth IVDA since age 13, newly diagnosed with HIV and severe cardiovascular comorbidity

Needs simplification of his HIV regimen.

- AST: 56, ALT; 73, Albumin 4.2, INR:1.0

- HCV gen 3A. Liver fibrosis- Imaging ?

- 90 days sober-Housing: on rehab -Rehab is far (Vista 45min drive)-Takes bus-In a relationship

Reassessment:- CV status- Psychiatry evaluation


The strategy: Let Nick earn his change to HCV therapy, ‘we can help but the work is yours’

Salute his presence in the clinic regardless of misunderstanding

Patient was informed that at this point he was an unfavorable candidate to initiate HCV treatment: Medical, social and uncontrolled HIV

Team acknowledge that he has taken important step-forward to ‘rebuilding his live’.

Team explain that he can become eligible and we can help!


Our ‘CCR’ rule:

Commitment: ‘Show me the money’

(HIV viral load undetectable)

Consistency: Follow through with medical

recommendations and or appointment

Reliability: Avoid ‘no shows’ ,call to ‘reschedule’.


1/13/12

HCV intake appointment“Baseline labs”

1/17/12

Pharmacist visit: -HCV education- Change ARV: Complera

1/25/12

Psychiatry visit

No show

2/10/12

End of clinic day:Call rehab center, patient reported transportation issues.Reminded him “Reliability rule”

2/3/12

2nd HCV visit - Review psych recomm. - Verify adherence: CD4, VL- Cardiology referral

Cardiology Euvolemic, EF 52%

4/30/12

3rd HCV visit: Encourage to follow with Cardiology

3/23/12

4rd HCV visit:Needs Substance counselor evaluation.

- Substance counselor &- Pharmacy visit

5/3/125/11/1

2HIV VL =262

HIV VL < 48


5/25/12

5th HCV visit: Treatment initiation in clinic with peg-INF + RBV

Pharmacy visit:Medication Safety

& “Monitoring assignment group “


0 1 2 3 4 5 6 7 8 9 10 11 12 14 16 18 20 22 24 26 28 30 32 34 36 40 44 48

Group 1

Pharmacists X X X X X X X X X X X X X

Providers X X X X X X X X X X X X X

Group 2

Pharmacists X X X X X X X X X X X X X X X X X

Providers X X X X X X X X X X X X

Group 3

Pharmacists X X X X X X X X X X X X X X X X X

Providers X X X X X X X X X X X X X X X X X X X X X X X X

Homeless1

Group 1: patients without major significant medical comorbidity, social barriers and no ongoing illicit substance useGroup 2: patients with ongoing substance use (including intravenous) and/or homelessnessGroup 3: patients with severe neuropsychiatry disease (including prior suicidal attempts) and/or medical comorbidity Cachay et al, AIDS Res Ther. 2013 Mar

28;10(1):9

‘Monitoring of HCV therapy requires individualization’’


HIV intake visit-Staging labs-Genotype

Follow-up visit-HAART initiation

1 month

“No especial laboratory monitoring”


Work prospectively with your patient to help them becoming a favorable HCV candidate and build provider-patient relationship

Intake

HIV

No show

HCV Treatme

nt initiation

1

2

3

4

5B

BC

“Multiple appointments, redirection and positive reinforcement”

5 months


Nick’s course following HCV treatment initiation

SVR at week 4Very irritable week 10, required Abilify

adjustment by psych at week 11Week 16: Dose reduction ribavirin from

1200mg to 800mg due to anemiaNo show week 20, 22, 23. Outreached

efforts. Returned week 24Finished 48 weeks HCV therapy 4/26/2012

and HCV RNA remains undetectable


Clinic Model High-risk

(n= 17)

Non-high-

risk

(n=31)

P value

№ Patients with Sustained viral response (%)

5(29) 16(52)0.14

№ Patients who discontinued HCV therapy due to non-viral response (%)

2(12) 7(23)0.36

№ Patients who discontinued HCV therapy due to treatment-related side effects (%)

6(35) 8(26)0.49

№ Patients lost to follow-up (%) 3(18) 1(3)0.08

Cachay et al, AIDS Res Ther. 2013 Mar 28;10(1):9

Successful HCV treatment of HIV patients with ongoing barrier to care is possible!

There were no differences between groups in age, ethnicity, liver fibrosis, proportion of HCV genotype, baseline laboratory exams , HCV RNA , CD and HIV VL.


Some ideas to overcome barriers in HIV/HCV vulnerable populations

Patients benefit from ‘prospective engagement’ (coaching) to help them becoming HCV treatment eligible

Treatment decision and long-term success relies in more than ‘staging liver fibrosis’

HCV monitoring needs to be tailor based on individual patient needs

‘Seek-test-treat’ is widely accepted but comes with an inadequate ‘sit and wait’ strategy (referral dependent), thus:

we need to scale up multidisciplinary collaborative HIV

models of care. Copyright © Edward Cachay MD, MAS.

2011: A major step forward in the treatment of HCV

Adapted from McHutchison et al. N Engl J Med. 2009, 360:1827-38

0 3 6 9 12

15

18

21

24

0

1

3

2

4

5

6

7

8

week

Log

10 m

ean

H

CV

RN

A (

UI/

ml)

Limit of detection( 10 UI/ml)

T12PR48PR48 (control)


Limited Efficacy With Telaprevir & Boceprevir

1. Zeuzem S, et al. N Engl J Med. 2011;364:2417-2428.2. Bacon BR, et al. N Engl J Med. 2011;364:1207-1217. 3. 3. Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416. 4. Poordad F, et al. N Engl J Med. 2011;364:1195-1206. 5. Bronowicki J, et al. EASL 2012. Abstract 11. 6. Zeuzem S, et al. EASL 2011. Abstract 5.

0

20

40

60

80

100

SV

R (

%)

Relapser Naive White

Null Responde

r

Naive Black

Partial Responde

r

Cirrhotic Null

Responder

68-75[3,4]

53-62[3,4]

*Pooled TVR arms of REALIZE trial.

75-83[1,2]

40-59[1,2]

29-40[1,5]

14[6]*

42-62[3,4]

NaiveCirrhotic

Room for Improvement in All Patient Groups


1. Receptor binding and endocytosis

2. Translation & polyprotein processing

3. RNA replication and virion assembly

Fusion & uncoating

4. Transport & release

(+) RNA


5’NTRStructural proteins

Non-structural proteins 3’NTR

CE1

E2

NS1

NS2

NS3NS4

A

NS4B

NS5A

NS5B

p22

gp35

gp70 p7 p23

p70 p8

p27 P56/58

p68

Gene encoding precursors polyprotein

envelopeglycoprotein

sTransmembra

neprotein

Proteases RNA

helicase

co-factors RNA polymeras

eInterferon resisting protein

9600 nt bases

Hepatitis C virus RNA

nucleocapside


Lian TJ, Ghany MG . 2013 NEJM 368: 1907-1917


Protease inhibitors

Polymerase inhibitors NS5A inhibitors

Nucleos(t)ide analogs

Non-nucleoside analogs

Daclastavir

Telaprevir* Sofosbuvir Tegobuvir Ledispavir

Boceprevir* Mericitabine Filibuvir IDX-179

Simeprevir IDX-184 BI-7127 ABT-267

Faldaprevir ALS-2200 Setrobuvir MK-8742

Asunaprevir ALS-2158 VX-222

Danoprevir ABT-072

Vaniprevir ABT-333

Mk-5172 BMS-1325

GS-9256

GS-9451

ABT-450

Sovaprevir

Narlaprevir

Adapted from Expert Opin Pharmacother. 2013;14:1161-70Copyright © Edward Cachay MD, MAS.

PI + PR

Faldaprevir + PR

Simeprevir + PR

Danoprevir /r+ PR

NS5B polymerase inhibitor

+ PR

Sofosbuvir + PR

Mericitabine + PR

NS5A inhibitor + PR

Daclastavir+ PR

Interferon sparing

regimensTelaprevir

+ VX222+R

BVFaldaprevir+

B1207127±RBV

Asunaprevir+

Daclastavir

Sofosbuvir+ RBV

SofosbuvirDaclastavir+ RBVABT450/r+ ABT267+

ABT333+RBV

Asunaprevir+

Daclastavir +

BMS 791325

QUAD therapy

Asunaprevir+

Daclastavir+PR

Danoprevir/r+

Mericitabine + PR

Searching for the right combination!


NS3 protease inhibitors

Ns5B polymeraseNucle0s(t)ide analogs

Ns5B polymeraseNon-nucleoside analogs

NS5A inhibitors

Mechanism of inhibition

Inhibitory competition

Inhibitory competition

Allosteric ?

Genotype activity

G1 (G1b >1a)

Across all G1 (G1b >1a) Across all (G1>G1a)

Resistance barrier

low high low low

Cross-resistance

High Low Split out in 4 families High

Drug interactions

PK Pharmacodynamic PK PK

Adapted from Expert Opin Pharmacother. 2013;14:1161-70

Virus Pyrimidine analogs Purine analogs

Cytidine Uridine/thymidine Adenosine Guanosine

HCV Mericitabine Sofosbuvir Ribavarin

HIV LamivudineEmtricitabine

ZidovudineStavudine

DidanosineTenofovir

Abacavir

HBV LamivudineEmtricitabine

Telbivudine AdefovirTenofovir

Entecavir

CMV Ganciclovir

Herpes Acyclovir

Courtesy Dr. Vicente Soriano-Personal communication May 2013Hospital Carlos III- Madrid, Spain


IFN pegIFN-RBVTripl

eAll oral

DAA

Su

stain

ed

vir

al

resp

on

se

(cu

re)

1990s 2000s 2011 2015

10%

35%

65%

> 90%

No.

Adapted from Expert Opin Pharmacother. 2013;14:1161-70


There is still crude reality in HIV patients co-infected with HCV

Unbalance number of patients with HIV with immediate urgency of HCV treatment.

Limited number of potential available slots for developing or forthcoming clinical trial enrollment

For some patients off label use of triple therapy is only real option

Need to be familiar with management side effects and potential unexpected adverse events in HIV unselected populations


Management of HIV/HCV co-infected genotype-1 patients accoring to fibrosis stage and prior treatment oucome

EACS guidelines. November 2012

F0F1

F2F3

F4

NaiveRelaps

er

Non-responder

Individual

decision

Triple therapy

IndividualDecision/ triple

therapyDefer

Triple therapy

Triple therapy

Triple therapy

Triple therapy

Defer

Adapted from: Ingiliz P, Rockstroh J. Liver International 2012; 32: 1194-9


4840 12 3624

HCV treatment regimens using protease inhibitors

Boceprevir+ Peg-IFN + RBVPeg-IFN + RBV

≥100 IU/mL:Stop HCV triple

therapy

Detectable:Stop HCV triple

therapy

Telaprevir + Peg-IFN + RBV Peg-IFN + RBV

>1000 IU/mL:Stop HCV

triple therapy

>1000 IU/mL:Stop HCV therapy

Detectable:Stop PR

DetectableStop PR


Before treatment Symptoms following HCV

treatment initiation

Nº of assessments Nº of assessments

Tota

l sco

res

of s

íym

ptom

s

Esco

res

tota

les

de

sínt

omas

Cachay et al. 2011, AIDS Res Ther.;8:29

0 510

15

20

25

1 432 5 6

40

60

80

10 0

12 0

40

60

80

10 0

12 0


Lian TJ, Ghany MG May 16, 2013NEJM 368: 20 page 1911


Data from phase II clinical trials among HIV-infected patients… is HCV triple therapy really safe?

(%) Discontinue HCV therapy due to adverse events

Telaprevir vs. placebo

8 vs 0

Boceprevir vs. placebo

20 vs 9


Adversereaction

Telaprevir (N = 38)

Placeb0 (N = 22)

Fatigue 39 41

Fever 18 9

Myalgia 13 23

Headache 34 23

Dizziness 21 9

Nausea 32 18

Diarrhea 21 14

Vomit 16 9

Pruritus 34 5

Skin rash 34 3

Anemia 13 18

Insomnia 13 18

Depression 16 9

GI

DERM

HEM

SOMA

PSYCH Sulkowski MS, et al. AASLD Nov 2012.

Abst. 54.

Adverse reactions using boceprevir HIV-infected patients


TINO is a 35yo HIV MSM HIV+ patient co-infected with HCV who wants to try to ‘get rid of his HCV virus’.

- HCV Gen 1A, HCV RNA 1.2 million, prior HCV viral relapse x2, recent liver fibrosis F5/6, IL 28 C-T.-He had suicidal ideation at week 24 of HCV therapy at week 24 of his last treatment trial in December 2007-Tino takes Truvada + Prezista/norvir and had no prior history of resistance. CD4 289 (19%) and HIV VL < 40.-Following a 6 months prospective staging Tino is about to start HCV triple therapy using Telaprevir.


What would you recommend to his current HAART

1. No changes are needed because TINO’s HIV viral load is already undetectable2. Significant bidirectional interactions between darunavir, telaprevir and ritonavir are expected and therefore needs to change his protease inhibitor.


Van Heeswijk. CROI 2011.

TVR alone

TVR + ARV

Time (hours)

AUC ↓ 54% AUC ↓ 20% AUC ↓ 35% AUC ↓ 32%

LPV ATV DRV fAPV

n=12

n=14

n=11

n=18

n=14

n=17

n=16

n=20


APV = amprenavir

van Heeswijk. CROI 2011.

PI AlonePI + TVR

AUC ↔

n=12

n=19

AUC ↑ 17%

n=7

n=11

PI AlonePI + TVR

PI AlonePI + TVR

AUC↓ 40%

n=11

n=16

PI AlonePI + TVR

AUC↓ 47%n=18

n=20


NRTI NNRTI Protease inhibitor(boosted)

Integrase inhibitors

CCR5 inhibitors

Combos

AZT* d4T* DDI*

ABC TDF 3TC/FTC

Nevirapine*

Efavirenz

EtravirineRilpivirine

LopinavirDarunavirTipranavirFosamprenavir

AtazanavirRaltegravir Maraviroc

Stribild??

Atripla

Complera

A practical way to recognize medical interactions between HIV medications and HCV

protease inhibitors


* Safety concerns but no interactions

1 week later TINO (week 3 of therapy) TINO returns because ‘his seborreic dermatitis’ has worsened.


Your medical recommendation to TINO is:

1. Discontinue HCV triple therapy immediately2. Apply topical steroids, ketoconazole and arrange a dermatology referral and f/u in 1 week with you3. Decrease peginterferon from 180 to 90mcg/week4. Decrease ribavrin to 600mg/day, add topical hydrocortisone bid, with topical ketoconazole.


Grade 1 rash

Grade 2 rash

Grado 3 rash

Severe skin reactions

Localized or limited distribution( can include different small parts of body except mucosa and together <30% body surface)

Diffuse eruption < 50% body surface

Diffuse eruption > 50% body surface and/or associated with systemic symptoms, target lesions or vesicles

Steven-JonhsonDRESSSJSErythema multiform


5 days following initiation of triple therapy: 1. diffuse nature of rash all over back


0 1 2 3 4

15.1

11.610.

7 9.2

peg interferon 180 mcg SQ weekly on Friday clinic visits + Ribavirin 400 mg PO in the AM and 600 mg PO in the PM + Telapravir 750 mg PO TID with a high fat meal.

HCV RNA

6‘300,000

HCV RNA=

212

HCV RNA=

56

HCV RNA=

49

?

HCV RNA ?

Weeks on HCV therapy

Hemoglobin (g/dL)

Epoetin Alfa 40,000 U/w


What would be your next step in managing Terry’s anemia?

1. Wait for CBC in today’s visit, if Hb<10, hold ribavarin2. Immediate RBV dose reduction to 600m/day and reassess in 1 week3. Decrease Telaprevir dose to 700mg bid4. Wait for CBC in today’s visit, if Hb<10, decrease ribavarin to 600mg and increase EPO to 40,000U x3 per week.


Ribavirin Dose Modification Patients who Received Telaprevir Combination Treatment: No Impact on Sustained Virologic Response in Phase 3 Studies

n/N =0

20

40

80

100

SV

R (

%)

60

291/395

16/38 38/51 13/24346/439

133/92

74

42

75

54

79

46

≤ 600mg ribavarin

Never reducedDose ribavarin

T12PR PR

800-1000mg ribavarin

M Sulkowski et al. 47th International Liver Congress (EASL 2012). Barcelona, April 18-22, 2012. Abstract 1162


0 1 2 3 4

15.1

11.610.

7 9.2

peg interferon 180 mcg SQ weekly on Friday clinic visits + Ribavirin 400 mg PO in the AM and 600 mg PO in the PM + Telapravir 750 mg PO TID with a high fat meal.

HCV RNA

6‘300,000

HCV RNA=

212

HCV RNA=

56

HCV RNA=

49

HCV RNA = undetectable

Weeks on HCV therapy

Hemoglobin (g/dL)

7.5


Hb ≤ 10* Decrease Ribavirin to 600mg Procrit 40,000 IU/week

ValueTime

Re-evaluate in 1 week

Re-evaluate in 1 week

“ Frequently monitor ‘complete blood counts’ during therapy”

D/c Procrit

Hold ribavarin for a week

Ribavirin 200mgD/c HCV

treatment


Our experience between July 2011-September 2012:

We noted a high incidence of severe adverse events associated a telaprevir combination therapy in an unselected HIV population

Our observed HCV treatment interuption due to severe adverse events was triple that described in phase 2 clinical trials (29% vs. 8% ).


Patient disposition according to grade IV adverse events-related to HCV triple therapy and subsequent HCV treatment discontinuation, stratified by severity of liver fibrosis score

HCV triple therapy (n=24)

Adverse reactions grade IV1 (n=12)

Anemia (n=5) Fmininal = 2

Fadvanced=3

Neutropenia (n=2) Fminimal = 1

Fadvanced = 1

Infections (n=3) Fminimal = 1

Fadvanced = 2

Skin rash (n=2) Fminimal = 1

Fadvanced =1

Psyquiatrics (n=1) Fminimal = 1

Fadvanced = 0

Liver failure (n=1) Fminimal = 0

Fadvanced = 1

Anemia (n=1) Fminina = 1

Favanzada=0

Infecciones (n=2) Fmínima = 1

Favanzada= 1

Dermatologicas (n=2) Fmínima = 1

Favanzada =1

Psiquiátricas (n=1) Fmínima = 1

Favanzada = 0

Failla hepática (n=1) Fmínima = 0

Favanzada= 1

HCV treatment discontinuation due to severe adverse

reactions (n=7)

Cachay et al, under review Copyright © Edward Cachay MD, MAS.

ConclusionsEngagement, staging and monitoring of HCV therapy among HIV patients requires ‘prospective’ collaborative ‘team work’ in orders to help our patients to overcome their barriers to care.HCV triple therapy is associated with high incidence of severe adverse events in HIV patients. There is need to increase education about HCV of patients and physicians to accelerate transition to new models of HCV care for HIV patients.


Acknowledgements1. Our patients for being the fuel of collaborative creativity2. Owen co-infection team members: + Craig Ballard

+ Brad Colwell + Francesca Torriani + David Wyles + Joe Montanez + Jennifer Lin

3. Dr. Christopher Mathews: Mentorship


edward cachay md, mas associate professor of medicine ucsd-owen clinic copyright © edward cachay...

Documents

hcv treatment

hcv rna

hcv genotype

hcv consideration

main hiv clinic

hiv provider

new hcv interferon

hepatitis c hcv therapy