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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
**-ASVIR** HCV Medication Class Suffixes ​DAA (direct acting antivirals)
_**NS5A Replication Complex Inhibitors**_ NS5**A** =**-A**svir ledip / ombit / daclat / elb / pibrent
26
**-BUVIR** HCV Medication Class Suffixes ​DAA (direct acting antivirals)
* *_NS5B_** * *_Polymerase Inhibitors_** NS5**B** = **-B**uvir **sofos / dasa**
27
**Sime-previr** ## Footnote **SMV**
**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
**Sofos-buvir** **SOF**
**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
**Ledi-Pasvir** / **Sofos-Buvir** ## Footnote **LDV / SOF**
**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
**PrOD or PrO**
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
**Daclat-Asvir** **DCV**
**NS5A** Replication Complex Inhibitor * *_NOT USED DUE TO PRICE_** * *2 copays** = 2 drugs & newer FDC regimens
32
**Elb-Asvir / Grazo-Previr** **EBR / GZR**
**NS5A** **RCI**nhibitor / **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
**Sofos-Buvir / Velpat-Asvir** **SOF / VEL**
**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
**Sofos-Buvir / Velpat-Asvir / Voxila-Previr** **SOF / VEL / VOX**
**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
**Gleca-Previr / Pibrent-Asvir** **G / P**
**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
**What DAA Treatments are indicated for** **ALL GENOTYPES?**
**SOF / VEL** **SOF / VEL / VOX** * *G/P** * *Gleca-Pravir / Pibrent-Asvir**
37
**What DAA treatments are an** **8 week treament?**
*most treatments are 12 weeks!* GT1 / Naive / Non-cirrhotic: **_G/P_** GlecaPrevir / PibrentAsvir = ONLY 8 week & CHEAP **LDV / SOF** = 8-12 weeks
38
**What DAAs / HCV Treatments are** **okay for RENAL IMPAIRMENT**
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
**What DAAs / HCV Treatments are ​** **safe for use in HEPATIC Impairment**
* *Cirrhosis / Child-Pughs B+C** * generally SOF backbones are safe, except VOX* **LDV / SOF** **DCV + SOF** * *SOF / VEL** * (not w/ VOX)*
40
**What DAAs / HCV Treatments** **need to be taken WITH FOOD?**
**G / P** **SOF / VEL / VOX** (*VOX requires the food, only VEL does not need food)* PrOD SMV / SOF
41
**What DAAs / HCV Treatments are** **1 Pill ONLY**
**SOF / VEL +/- VOX** **EBR / GZR** **LDV / SOF**
42
What DAAs / HCV Treatments are ## Footnote **the CHEAPEST**
**1 Copay** **G / P** **EBR / GZR**
43
**What DAAs / HCV Treatments are** * *used for NS5A or NS3 Failures** * NOT BOTH*
* *used for NS5A or NS3 Failures** * NOT BOTH* **G / P** **SOF / VEL / VOX**
44
**What LABS** are **monitored** for **HCV**
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
**Why is HEP B Tested for before HCV Treatment?**
**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
What **Labs are Monitored at** ## Footnote **Week 4 & 12 Weeks of treatment**
**_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
What do you need to know to **SELECT an HCV Treatment**
**_GENOTYPE_** **_Previous Treatment History_** _Presence/Absence of_ **_Cirrhosis_** **Child-Pughs Assessment** **Renal** Impairment / **Post-Transplant** **Concomitant medications**
48
Recommended HCV Regimens for * *Naive / Non Cirrhotics** * *GT 1A / 1B**
* *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
Recommended HCV Regimens for **Naive / COMPENSATED Cirrhotics** **GT 1a / 1b**
**_ALL ARE 12 WEEKS_** **G / P** **EBR / GZR** **LDV / SOF** **SOF / VEL**
50
**Special Populations** **in HCV**
**_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
**HCV / HIV CO-Infection**
**NO CHANGES!** Just have to **manage the DDIs** data shows that there is **STILL A GOOD RESULT** **SVR \> 95%**
52
**Renal Impairment in HCV Treatment**
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
**Recommended HCV Regimens in** **SEVERE Renal Impairment** **\<30 mL/min or ESRD**
* *_EBR / GZR_** * *12 weeks** for GT **1A/B + 4** * *_G / P_** * treat based on _treatment history & stage_* * *8-16 weeks** for ALL GTs
54
**Hepatic Impairment in HCV Treatment**
* *_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
**HCV Treatment for** **DECOMPENSATED Cirrhosis**
* *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
**Which HCV Regimen for DECOMPENSATED Cirrhotics** **require a WEIGHT BASED RBV**?
**_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
**Which HCV Regimens for DECOMpensated Cirrhotics** Treat **GT 1/4**
**_ALL 3 REGIMENS_** 12 weeks / \>24 weeks without RBV **LDV / SOF** **SOF / VEL** * *DCV / SOF** * expensive as hell*
58
**Which HCV Regimens for DECOMpensated Cirrhotics** Treat GT **5/6**
**LDV / SOF** **_SOF / VEL_** (treats ALL, but needs weight based RBV) *DCV / SOF does not treat GT 5/6*
59
**Which HCV Regimens for DECOMpensated Cirrhotics** Treat GT **2/3**
*LDV / SOF does not treat 2/3* **_SOF / VEL_** works for all 3 but needs a weight-based RBV **DCV + SOF**
60
**HCV Treatment for** **POST-Liver Transplant**
**Some** regimens **_need RBV_** **Watch DDIs w/ immunosupression** **Varies on CTP (Child-Pughs)** **Score** **MOST have SOF**
61
**Recommended HCV Treatment for** **POST LIVER Transplant & CTP A**
_For GT_ **_1,4 / 5,6_** **LDV / SOF** (*weight based)* * *G / P** * non-cirrhotic* _For GT **2,3**_ **DCV + SOF**
62
Recommended HCV Treatment for ## Footnote **POST LIVER Transplant & CTP B/C**
*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
**Drug Interactions of DAAs** & **TACROLIMUS** Which ones are **generally OKAY to take together**
**Tacrolimus = immunosupressive for TRANSPLANT** **DCV** **LDV / SOF** **SOF / VEL** *G/P and others have potential drug interactions need to adjust dose*
64
**Ribovirin** **RBV Dosing / Considerations**
* *_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

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