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PDAT2 > 22/23 - Hep C > Flashcards

22/23 - Hep C Flashcards

1
Q

HCV Basics

A
  • *SS-RNA** Virus
  • *WITHOUT proofreading polymerase**

6 HCV Genotypes w/ treatment recommendations
+ 67 subtypes (a/b/c….)

Genotype 1 = MOST COMMON in US: 75%
(1a>>1b)

Genotypes 2 & 3 = ~20-25%

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2
Q

Decline in ACUTE HCV Cases from 1992-2005

Caused by WHAT?

A

2nd generation of Antibody tests

We know how to Diagnose & PREVENT it

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3
Q

WHY are Acute HCV Cases on the RISE in the US?
2010-now

A

INCREASE IN

IV DRUG USE

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4
Q

Symptoms of ACUTE HCV

& When do they appear

A

FATIGUE
but MOST Patients are ASYMPTOMATIC

Symptoms would appear in
4-12 Weeks after infection

Does NOT just Affect the liver:
ExtraHepatic Manifestations, even in the absence of cirrhosis

Arthralgia / diabetes / cryogloulinemia / dermatologic

Fever / loss of appetite / NV
Ab Pain / Jaundice / Choluria / Joint Pain
Clay-Colored Stool

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5
Q

When are Antibodies / RNA Detectable in the blood

for HCV?

A

Incubation of Acute HCV = 2wks - 6mo

AntiBodies
4-10 weeks after infection
takes time to be detectable

  • *RNA**
  • *2-3 weeks** after infection

symptoms CAN appear in 4-12 weeks

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6
Q

HIGH RISK

for HCV Transmission

A

IV Drug use

Blood Transfusion / Solid Organ Xplants
PRIOR to 1992

Clotting Factors
PRIOR to 1987

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7
Q

Lower Risk
for HCV Transmission

A

PeriNATAL Transmission / SEXUAL Transmission

Hemodialysis

IntraNASAL Drug Use

Occupational Exposure

TATTOOS / Accupuncture / Bodypiercing

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8
Q

Prevention for HCV

A

COUNSEL Patients to AVOID Risk factors

NO VACCINE
due to MANY mutations/strains & variation in genotypes/subtypes

NO Pre/Post-Prophylaxis Recommended

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9
Q

HCV SCREENING
Recommendations

3 Focus

A

All Patients W/ Risk Factors

  • *EVERYONE** Born between 1945 - 1965
  • regardless of risk factors*, due to IV Drug Use

ANNUAL testing of pts with ONGOING Risk Factors
IV Drug users
HIV+ men who have MM sex

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10
Q

Recommendations for HCV Screening

A
  • Anyone born between 1945 and 1965
  • Current or past use of injection drug use
  • Coinfection with HIV
  • blood transfusions or organ transplantations before 1992
  • Received clotting factors before 1987
  • Patients who have ever been on hemodialysis
  • unexplained elevated ALT levels or evidence of liver disease
  • needle-stick or mucosal exposure to HCV-positive blood
  • Children born to HCV-positive mothers
  • Sexual partners of HCV-positive patients
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11
Q

Which Chronic Infection has the
HIGHEST MORTALITY RATE
in the US

A

HCV

Used to be HBV but in 2006 –> HCV
due to baby boomers –> Cirrhosis developing

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12
Q

Diagnosing Proceedure for

HCV

“ARG”

A

HCV AntiBody
Prior or current exposure to HCV, requires further evaluation
if positive test….

HCV RNA level
Prior HCV infection may indicate prior resolution or prior successful treatment
if detectable then….

HCV GENOTYPE
helps determine the treatment options

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13
Q

What does this Indicate?

HCV Antibody = +Positive

HCV RNA Quantitative = +/-

A
  • *Detectable HCV RNA**
  • *Acute or Chronic HCV Infection**
  • NOT* detected HCV RNA
  • Spontaneous resolution** of HCV Infection = *RARE ~15%
  • *or successful treatment**
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14
Q

What does this Indicate?

HCV Antibody = -negative-

HCV RNA Quantitative = +/-

A

DETECTABLE HCV RNA
EARLY Acute infection
or Chronic HCV infection in an immunocompromised patient

  • NOT detectable*
  • double negative = NO HCV infection*
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15
Q

HCV Antibody Test

A

OraQuick HCV

FDA Approved Rapid AB Test 2011

1uL BLOOD sample –> 20 min

98% accurate in detecting HCV AB

still requires confirmatory testing

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16
Q

HCV Progression

A

15% can Resolve ON THEIR OWN

85% –> CHRONIC –> 20% develop Cirrhosis

3-6% / year –> decompensation -> ESLD/Transplant

1-4% / year –> HCC = CANCER

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17
Q

Stages of LIVER FIBROSIS

A

METAVIR Scoring

(no fibrosis) F0 -> F4 (worst)

F4 = CIRRHOSIS / Advanced Liver Fibrosis

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18
Q

Determination of FIBROSIS STAGE

A
  • *NON-Invasive Labs**
  • *APRI** = AST to PLATELET Ratio Index
  • *FIB-4** = Calculation
  • *Fibrosure** = Biochemical Marker Index
  • *Non-invasive PROCEDURES**
  • *FIBROSCAN** = Transient Elastrography
  • *MRE** = Magnetic Resonance Elastrography

Liver Biopsy = Invasive

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19
Q

FIBROSCAN

A

Transient Elastrography

Non-Invasive Procedure for determining Fibrosis Stage

Uses VIBRATION** to measure the liver’s **STIFFNESS
kPa of >12.5 = F4
Fibrosis / excessive scarring

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20
Q

Goal of HCV Treatment

A

Eradication of Infection
SVR = CURE
Sustained virological response, undetectable viral load
12 weeks AFTER treatment completion

We wait 12 weeks and test again to make sure that the
HCV does NOT come back

  • *PREVENTION** of Complication & Death from:
  • *Cirrhosis / ESLD + Liver Transplant / HCC**
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21
Q

Why do we SCREEN if we do NOT or can NOT Treat?

A

KNOWLEDGE IS POWER

LIFESTYLE CHANGES
&
Monitor for HCC
if F3 or F4

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22
Q

RIBAVIRIN
RBV

Indication / ADR / Warnings

A

Antiviral for HCV GT’s 1-6

  • *NOT effective as MONOTHERAPY**
  • *ALWAYS** used with Other DAA

weight based dosing + renally adjusted

Anemia -> fatigue

pregnancy cat X = teratogenic
MUST USE 2 Forms of contraception & 6mo’s after D/C

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23
Q

HCV RNA Components

A

Structural Proteins = Core + E1 + E2

Non-Structural Proteins
NS3 / NS4A / NS5A+B
are ALL TARGETS

  • we do NOT have targets for:*
  • *NS4B / NS2**
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24
Q

-PREVIR

HCV Medication Class Suffixes
DAA (direct acting antivirals)

A

_NS3/4A
Protease Inhibitors_ (PIs)

P = Protease Inhibitor

-previr

sime / parita / grazo / voxilla / gleca

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25
Q

-ASVIR

HCV Medication Class Suffixes
​DAA (direct acting antivirals)

A

_NS5A
Replication Complex Inhibitors_

NS5A =-Asvir

ledip / ombit / daclat / elb / pibrent

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26
Q

-BUVIR

HCV Medication Class Suffixes
​DAA (direct acting antivirals)

A
  • *NS5B**
  • *Polymerase Inhibitors**

NS5B = -Buvir

sofos / dasa

27
Q

Sime-previr

SMV

A

NS3/4A Protease Inhibitor
used with RBV (Ribavirin)

RARELY USED IN THERAPY
2- copays & fewer FDC regimens

Child-Pugh Class B/C = Not Used
hepatic issues / decompensated

28
Q

Sofos-buvir

SOF

A

NS5B Polymerase Inhibitor

HUGE BACKBONE used with many other DAA’s:
Good for ALL Genotypes = GT: 1-6 W/ other agent

DI: P-GP transporters, active metabolite

NOT USED FOR RENAL IMPAIRMENT
CrCl < 30 ml/min or ESRD/hemodialysis

no adjustments for HEPATIC

29
Q

Ledi-Pasvir / Sofos-Buvir

LDV / SOF

A

NS5A / NS5B

  • *1 pill combo** for GT’s 1/4/5/6 ,but NOT for all GT’s no 2/3
  • *8-12 Week** treatment

DI: requires acidic environment / discuss antacid use
P-gp substrate

NOT USED FOR RENAL IMPAIRMENT
CrCl < 30 ml/min or ESRD/hemodialysis

no adjustments for HEPATIC

30
Q

PrOD or PrO

A

NS3/4A PI / Ritonavir / NS5A +/- NS5B

RARELY USED DUE TO DRUG INTERACTIONS
due to RITONAVIR = booster that makes everythign WORSE
inhibitor of CYP3A4 / BCRP / P-gp
3A4 & 2D6 substrate

CI w/ hepatic impairment

Not defined for <15ml/min CrCl

31
Q

Daclat-Asvir

DCV

A

NS5A Replication Complex Inhibitor

  • *NOT USED DUE TO PRICE**
  • *2 copays** = 2 drugs & newer FDC regimens
32
Q

Elb-Asvir / Grazo-Previr

EBR / GZR

A

NS5A RCInhibitor / NS3 PI

1 Tab +/- RBV
for GT 1/2

GT1A:
Must check NS5A RESISTANCE @ Baseline & LFTs wk8/12

no adjustment for RENAL

NOT recommended for HEPATIC CP-B/C

33
Q

Sofos-Buvir / Velpat-Asvir

SOF / VEL

A

NS5B Polymerase Inhibitor / NS5A RCInhibitor

1 Tab = Approved for All GT’s 1-6

VEL needs acidic absorption + discuss antiacids

NOT used for RENAL impairment
CrCl < 30 ml/min or ESRD/hemodialysis

no adjustments for HEPATIC

34
Q

Sofos-Buvir / Velpat-Asvir / Voxila-Previr

SOF / VEL / VOX

A

NS5B PI / NS5A RCI / NS3/4A PI

1 Tab = ALL GT’s 1-6

for people who have FAILED PREVIOUS TREATMENT
DAA Failures

NOT used for RENAL IMPAIRMENT
CrCl < 30 ml/min or ESRD/hemodialysis

VOX ONLY:
NOT recommended for HEPATIC CP-B/C

35
Q

Gleca-Previr / Pibrent-Asvir

G / P

A

NS3/4A PI / NS5A RCI

  • *3 TABS** QD –> All GT’s 1-6
  • *8 week treatment** & CHEAP (1 copay)

Used for NAIVE PTs & DAA Failures
(NS5A OR NS3, NOT both)

no adjustment for RENAL

NOT recommended for HEPATIC CP-B/C

36
Q

What DAA Treatments are indicated for

ALL GENOTYPES?

A

SOF / VEL

SOF / VEL / VOX

  • *G/P**
  • *Gleca-Pravir / Pibrent-Asvir**
37
Q

What DAA treatments are an

8 week treament?

A

most treatments are 12 weeks!
GT1 / Naive / Non-cirrhotic:

G/P
GlecaPrevir / PibrentAsvir = ONLY 8 week & CHEAP

LDV / SOF = 8-12 weeks

38
Q

What DAAs / HCV Treatments are

okay for RENAL IMPAIRMENT

A

use in CKD / ESRD > 30 mL/min:
All are okay

Safe for DIALYSIS:
PrOD & EBR / GZR & G/P

if SOF
NOT USED FOR DIALYSIS

39
Q

What DAAs / HCV Treatments are ​

safe for use in HEPATIC Impairment

A
  • *Cirrhosis / Child-Pughs B+C**
  • generally SOF backbones are safe, except VOX*

LDV / SOF

DCV + SOF

  • *SOF / VEL**
  • (not w/ VOX)*
40
Q

What DAAs / HCV Treatments

need to be taken WITH FOOD?

A

G / P

SOF / VEL / VOX
(VOX requires the food, only VEL does not need food)

PrOD

SMV / SOF

41
Q

What DAAs / HCV Treatments are

1 Pill ONLY

A

SOF / VEL +/- VOX

EBR / GZR

LDV / SOF

42
Q

What DAAs / HCV Treatments are

the CHEAPEST

A

1 Copay

G / P

EBR / GZR

43
Q

What DAAs / HCV Treatments are

  • *used for NS5A or NS3 Failures**
  • NOT BOTH*
A
  • *used for NS5A or NS3 Failures**
  • NOT BOTH*

G / P

SOF / VEL / VOX

44
Q

What LABS are monitored for HCV

A

HCV Genotype / Subtype / RNA

HBsAg + HBcAb Total

CBC / INR

Creatinine / GFR

PREGNANCY Test
due to RBV, if indicated

Hapatic Liver Fxn Panel
albumin / bilirubin / ALT / AST / Alkaline Phosphatase

45
Q

Why is HEP B Tested for before HCV Treatment?

A

HBV Surface Antigen + Core Ab total
due to B+C
CO-INFECTION** & **REACTIVATION
29 cases of B being reactivated once C is treated

have to check HP B before treating hep C,
monitor DURING treatment

46
Q

What Labs are Monitored at

Week 4 & 12 Weeks of treatment

A

HCV RNA
for 12 weeks & 4 weeks
12 to see if HCV comes BACK

  • *CBC / Creatinine / GFR / Hepatic FXN Panel**
  • NOT INR*

HBV DNA
throughout if they were HBsAg +POS

47
Q

What do you need to know to
SELECT an HCV Treatment

A

GENOTYPE

Previous Treatment History

Presence/Absence of Cirrhosis
Child-Pughs Assessment

Renal Impairment / Post-Transplant

Concomitant medications

48
Q

Recommended HCV Regimens for

  • *Naive / Non Cirrhotics**
  • *GT 1A / 1B**
A
  • *G / P**
    • (8 week Treatment)*

LDV / SOF
8 weeks if: VL <6mil / not AA / no HIV
if NOT, 12 week treatment along with:

EBR / GZR

SOF / VEL

49
Q

Recommended HCV Regimens for

Naive / COMPENSATED Cirrhotics

GT 1a / 1b

A

ALL ARE 12 WEEKS

G / P

EBR / GZR

LDV / SOF

SOF / VEL

50
Q

Special Populations

in HCV

A

ELDERLY
there is NO “MAX” AGE,
treat if life expectancy is >12 months
do not treat if expected to die soon

  • *Pediatrics**
  • do not focus on, only 2 clinical trials*

Pregnancy
NO clinical trials for DAAs in pregnancy
LOW chance of vertical transmission, 12 week therapy dont give in pregnancy

51
Q

HCV / HIV CO-Infection

A

NO CHANGES!

Just have to manage the DDIs

data shows that there is STILL A GOOD RESULT

SVR > 95%

52
Q

Renal Impairment in HCV Treatment

A

If CrCl > 30mL/min; then there are NO CHANGES
general rule is if there is SOF, we do not use in renal impairment or Dialysis

<3 Options in ESRD / Dialysis
EBR / GZR —- PrOD —- G / P

RBV requires DOSAGE CHANGES
CrCl > 50 ml/min = no changes
CrCl 30 - 50 ml/min = 200mg - 400mg QD
CrCl <30 mL/min = 200 mg QD

53
Q

Recommended HCV Regimens in

SEVERE Renal Impairment

<30 mL/min or ESRD

A
  • *EBR / GZR**
  • *12 weeks** for GT 1A/B + 4
  • *G / P**
  • treat based on treatment history & stage*
  • *8-16 weeks** for ALL GTs
54
Q

Hepatic Impairment in HCV Treatment

A
  • *3** recommended regimens GT1
  • *generally if it does NOT have SOF, then it is okay**
  • exception is SOF/VEL/VOX + G/P*
  • *DCV + SOF —- LDV / SOF —– SOF / VEL**

RBV is generally added
if not we can extend the length of treatment

55
Q

HCV Treatment for

DECOMPENSATED Cirrhosis

A
  • *F4** or (F3 + HCC & Post Transplant)
  • *REFER TO TRANSPLANT CENTER**

If then we can treat with agents that HAVE SOF
exception is those wiith VOX / SMV**, can’t use these

LDV + SOF —- SOF + VEL —– DCV + SOF

all are 12 weeks

but if we can NOT use RBV = >24 weeks

56
Q

Which HCV Regimen for DECOMPENSATED Cirrhotics

require a WEIGHT BASED RBV?

A

VEL / SOF
requires weight-based RBV or a low dose RBV like the other regimens

12 week regimen for ALL GT 1,4 / 5,6 / 2,3

but if no RBV = >24 weeks

57
Q

Which HCV Regimens for DECOMpensated Cirrhotics

Treat GT 1/4

A

ALL 3 REGIMENS
12 weeks / >24 weeks without RBV

LDV / SOF

SOF / VEL

  • *DCV / SOF**
  • expensive as hell*
58
Q

Which HCV Regimens for DECOMpensated Cirrhotics

Treat GT 5/6

A

LDV / SOF

SOF / VEL
(treats ALL, but needs weight based RBV)

DCV / SOF
does not treat GT 5/6

59
Q

Which HCV Regimens for DECOMpensated Cirrhotics

Treat GT 2/3

A

LDV / SOF
does not treat 2/3

SOF / VEL
works for all 3 but needs a weight-based RBV

DCV + SOF

60
Q

HCV Treatment for

POST-Liver Transplant

A

Some regimens need RBV

Watch DDIs w/ immunosupression

Varies on CTP (Child-Pughs) Score

MOST have SOF

61
Q

Recommended HCV Treatment for

POST LIVER Transplant & CTP A

A

For GT 1,4 / 5,6
LDV / SOF
(weight based)

  • *G / P**
  • non-cirrhotic*

For GT 2,3
DCV + SOF

62
Q

Recommended HCV Treatment for

POST LIVER Transplant & CTP B/C

A

NO G/P because cirrhotic, CTP B/C

for GT 1,2 / 5,6
LDV / SOF
ONLY

for GT 2,3
DCV + SOF
SOF / VEL

63
Q

Drug Interactions of DAAs & TACROLIMUS

Which ones are generally OKAY to take together

A

Tacrolimus = immunosupressive for TRANSPLANT

DCV

LDV / SOF

SOF / VEL

G/P and others have potential drug interactions
need to adjust dose

64
Q

Ribovirin

RBV Dosing / Considerations

A
  • *MONITOR HEMOGLOBIN**
  • -> hemolytic anemia

Weight-based dosing
≤75mg: 1000mg
>75kg: 1200mg/day

Renally adjusted
–If CrCl > 50mL/min: no changes
–If CrCl 30 – 50 mL/min: 200mg – 400mg daily
–If CrCl <30 mL/min: 200mg daily

PDAT2 (22 decks)

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