Keri Earnshaw, RN, CCRP Jo-Ann Ford, RN, MSN BC Hepatitis Program Diamond Centre, VGH
Clinical Nursing Experience with Direct Acting Antivirals (DAA’s)
Disclosures – K. Earnshaw
•
Clinical Trials:
– Merck Canada, Hoffmann LaRoche,
Vertex Inc., Pfizer Canada, Johnson & Johnson, Gilead Sciences, Human
Genome Sciences, Boehringer
Ingelheim, Bristol-Meyers Squibb, Celsion Corp., Biosphere
Disclosures – J. Ford
• Clinical Trials:
– Merck Canada, Hoffmann LaRoche, Vertex Inc., Pfizer Canada, Johnson & Johnson, Gilead
Sciences, Human Genome Sciences,
Boehringer Ingelheim, Bristol-Meyers Squibb, Celsion Corp.
• Advisory Boards:
– Merck Canada, Hoffmann LaRoche, Gilead Sciences, Vertex Inc.
Presentation Objectives
• Clinical Experience with Boceprevir and Telaprevir (Phase 3 studies)
• Predictors of Response
• Importance of Adherence
• Discuss Treatment Algorithms
• Treatment initiation, and monitoring
• Impact of Boceprevir and Telaprevir on our practice
Background
• Prevalence HCV in Canada: 1-2%
• BC: Estimated 60,000 – 100,000 chronic carriers
• Up to 75% were unaware of HCV until liver disease or cancer years later (Mitchell AE, 2010)
• HCV in Canada
– Yesterday: recipients of blood transfusions – Today: horizontal transmission (IVDU)
U.S.A. 4 M SOUTH AMERICA 10 M AFRICA 32 M EAST MEDITERRANEAN 20M SOUTH EAST ASIA 30 M AUSTRALIA 0.2 M SOURCE, WHO WEST EUROPE 9 M FAR EAST ASIA 60 M
170 Million Carriers Worldwide 3% of World Population
HCV: A Global Health Problem
HCV Therapy: 2010
Genotype 1 in need of better therapies
2% 9% 17% 29% 38-41% 0% 20% 40% 60% 80% S us tai ned R es pons e
IFN 24w IFN 48w IFN-R 24w IFN-R 48w PEG-R
HCV hepatitis C virus; IFN interferon
TVR BOC
Protease Inhibitors (PIs) Licensed: Boceprevir
(BOC) and Telaprevir (TVR)
Boceprevir /Telaprevir™
Direct-Acting Antiviral Agents
Mechanism of Action: • Directly target HCV
• Inhibitor of the HCV NS3/4A protease.
• Bind to the NS3/4A protease active site and inhibits viral replication in HCV-infected host cells
24 wks Follow-up
HCV SPRINT-2 – Boceprevir +
PegIntron
®+ RBV in Naïve G1 – Phase
III
Randomization (1:1:1, stratified by G1 subtype and BL VL)
Study Weeks 0 48 72 CHC, G 1 , n a ïve , n = 1097 ( in cl . 159 A A ) PegIntron® 1.5 µg/kg/wk plus RBV 600-1400 mg/d
plus placebo (starting at study week 5)
PegIntron® 1.5 µg plus
RBV 600-1400 mg/d plus boceprevir 800 mg tid
PegIntron® 1.5 µg plus RBV 600-1400 mg
plus boceprevir 800 mg tid
28 4
* Pts in the 28-wk-arm who are HCV RNA undetectable at week 4 of boceprevir tx (=study week 8) and all subsequent assays will stop tx at wk 28
Pts who are not undetectable will stop boceprevir at week 28 and will continue with PegIntron® plus RBV alone for an additional 20 weeks
PegIntron plus RBV PegIntron plus RBV 8 * 24 wks Follow-up 24 wks Follow-up PegIntron® plus RBV plus placebo 44 wks Follow-up
SPRINT-2 – SVR (ITT)
38% 63% 66% 0% 20% 40% 60% 80% 100% S V R ( HCV RNA < 9. 3 I U/ mL )SOC Triple therapy - RGT Triple therapy - 48 wks
* *
* p<0.0001
Per protocol, if a pt did not have a 24-week tx assessment, the patient’s 12-week post-tx assessment was utilized
SPRINT-2: SVR and Relapse Rates (ITT)
0 20 40 60 80 100 P a ti e nts (% ) SVR Relapse 4-wk PR + 44 weeks BOC/PR 4-wk PR + response-guided BOC/PR 48-wk PR 67 68 40 8 23 9 0 20 40 60 80 100 P a ti e nts (% ) SVR Relapse 42 53 23 17 14 12Nonblack Patients Black Patients
P < .0001
P = .044 P = .004
Poordad F, et al. AASLD 2010. Abstract LB-4
SPRINT-2: SVR Rates in Patients Who
Qualified For 28 Weeks of Therapy
44% of patients qualified for 28 weeks of therapy (assessment at
Week 4 of BOC, ie Week 8 of therapy) in response-guided arm
0 20 40 60 80 100 Non-blacks SVR (% ) Blacks 87 97 n/N = 143/147 13/15
SPRINT 2: SVR Based on Week 4 PR Lead-In in Non-Black Patients
≥1 log10 HCV RNA decline from baseline
<1 log10 HCV RNA decline from baseline
52 82 82 5 29 39 0 20 40 60 80 100 48 P/R BOC RGT BOC/PR48 SVR (% )
* Boceprevir resistance-associated variants determined with population sequencing 121 234 187 228 178 218 3/62 21 73 31 79
Investigator-reported Clinical
Adverse Events
Adverse Event no. (%) Group 1 PR48 (N=363) Group 2 BOC RGT (N=368) Group 3 BOC/PR48 (N=366) Fatigue 217 (60) 196 (53) 209 (57) Headache 153 (42) 168 (46) 167 (46) Nausea 153 (42) 175 (48) 159 (43) Anemia 107 (29) 182 (49)* 179 (49)* Pyrexia 121 (33) 123 (33) 118 (32) Chills 102 (28) 134 (36)† 121 (33) Dysgeusia 64 (18) 137 (37)* 156 (43)* Insomnia 118 (33) 117 (32) 122 (33) *p<0.001; †p=0.02; vs. standard therapySPRINT-2 –
Discontinuation due to Adverse Events
16% 12% 16% 0% 20% 40% 60% 80% 100%
Discontinuation due to AEs
%
o
f p
ts
SOC Triple therapy - RGT Triple therapy - 48 wks
Boceprevir: Adverse Events
1. Poordad F, et al. AASLD 2010. Abstract LB-4.
• Anemia and dysgeusia reported more frequently
in BOC arms vs control in SPRINT-2
Outcome 4-Wk PR + Response-Guided BOC/PR (n = 368) 4-Wk PR + 44-Wk BOC/PR (n = 366) 48-Wk PR (n = 363) Adverse event, % • Anemia[1] 49 49 29 • EPO use 41 46 21 • Dysgeusia[2] 37 43 18 • Anemia discont. 2 2 1
Week 4 Week 48 PR + Placebo Follow-up PR lead-in PR + Boceprevir PR lead-in Week 36 Week 72 TW 8 HCV-RNA Undetectable TW 8 HCV-RNA Detectable/ TW 12 Undetectable PR + placebo Follow-up Follow-up
RESPOND-2: Study Arms and Dosing Regimen Control 48 P/R N = 80 BOC RGT N = 162
Peginterferon (P) administered subcutaneously at 1.5 μg/kg once weekly, plus Ribavirin (R) using weight based dosing of 600-1400 mg/day in a divided daily dose
Boceprevir dose of 800 mg thrice daily
PR + Boceprevir PR lead-in Follow-up BOC/ PR48 N = 161
HCV-RNA measured by the Cobas TaqMan assay (Roche). Patients with detectable HCV-RNA (LLD=9.3 IU/mL) at week 12 were considered treatment failures.
Week 12 futility
RESPOND-2: Treatment Experienced
SVR Rates According to Treatment Arm and Prior Response 0 20 40 60 80 100 Overall SVR ( % ) [1] 4-wk PR + 44-wk BOC + PR (n = 161) 59* Prior Nonresponders (Partial) Prior Relapsers 48-wk PR (n = 80) 4-wk PR + response-guided BOC + PR (n = 162) 67 21 40 52 7 75 29 69 P < .0001 vs control (both arms)
1. Bacon BR, et al. AASLD 2010. Abstract 216. These data are available in unpresented abstract format only and will be presented in full during the
AASLD meeting. We encourage you to review the presented data before making conclusions.
2. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data.
*46% of patients in response-guided arm eligible for shorter duration of therapy, with 86% SVR rate.[2]
PROVIDE STUDY
• Goal: To assess SVR rates of well documented prior null responders when treated with BOC + PR
• A single arm roll-over study
• SPRINT- 2 N=37
• RESPOND -2 N=11
• Discontinued during 4-week PR lead-in 3 (6%)
• Received BOC + PR 45 (94%)
• End of Treatment response: 47% (n=43)
• Achieved SVR 38% (Similar to telaprevir REALIZE study)
Subanalysis of Phase III Boceprevir Trials: SVR in Advanced Fibrosis/Cirrhosis
SPRINT-2: GT1 treatment-naïve
PR 4 wks, then BOC + PR 44 wks
PR 4 wks, then BOC + PR for 24 wks, then stop or PR + placebo 20 wks (RGT)
PR 4 wks, then PR + placebo 44 wks
RESPOND-2: GT1 relapsers and partial
responders to pegIFN/RBV
PR 4 wks, then BOC + PR 44 wks PR 4 wks, then BOC + PR for 32 wks, then stop or PR + placebo 12 wks (RGT) PR 4 wks, then PR + placebo 44 wks
Bruno S, et al. EASL 2011. Abstract 7..
F3/4 F0/1/2 100 80 60 40 20 0 SVR (% ) F0/1/2 38 67 67 38 41 52 328 319 n= 313 42 34 24 100 80 60 40 20 0 SVR (% ) F3/4 23 66 68 13 44 68 61 117 n= 19 31 32 15
Add Boceprevir Complete Treatment Undetectable HCV-RNA Undetectable HCV-RNA Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 28 Treatment-naïve Patients PegIFNα/ RBV Boceprevir + PegIFNα/RBV Week 12 Test* Stop Boceprevir Detectable HCV-RNA Undetectable HCV-RNA PegIFNα/RBV Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 48 Week 12 Test* Late Responder Early Responder Complete Treatment Add Boceprevir PegIFNα/ RBV
* Futility Rule: HCV-RNA ≥100 IU/mL at Week 12 or detectable HCV-RNA at Week 24, discontinue all treatment.
Boceprevir + PegIFNα/RBV
Add Boceprevir Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 48 Boceprevir + PegIFNα/RBV Week 12 Test* Complete Treatment PegIFNα/ RBV
* Futility Rule: HCV-RNA ≥100 IU/mL at Week 12 or detectable HCV-RNA at Week 24, discontinue all treatment.
Patients With Cirrhosis Treatment-naïve Patients
Previous Treatment Failure Patients PegIFN/Ribavirin Late Responder Early Responder Add Boceprevir Stop Boceprevir Detectable HCV-RNA Undetectable HCV-RNA PegIFNα/RBV Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 36 Week 48 Boceprevir + PegIFNα/RBV Week 12 Test* Complete Treatment PegIFNα/ RBV Add Boceprevir Undetectable HCV-RNA Undetectable HCV-RNA Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 36 Boceprevir + PegIFNα/RBV Week 12 Test* Complete Treatment PegIFNα/ RBV
Patients With Prior Null Response or Cirrhosis† Add Boceprevir Day 1 Start of Week 5 Week 8 Test Week 24 Test* Week 48 Boceprevir + PegIFNα/RBV Week 12 Test* Complete Treatment PegIFNα/ RBV
* Futility Rule: HCV-RNA ≥100 IU/mL at Week 12 or detectable HCV-RNA at Week 24, discontinue all treatment. † Null response defined as patients with <2-log10 HCV-RNA decline by treatment week 12 during prior therapy with PegIFNα/RBV.
ADVANCE AEs leading to DC and most common AEs % Pts. with T12PR T8PR PR Any AE 99 99 98 Fatigue 57 58 57 Pruritus 50 45 36 Headache 41 43 39 Nausea 43 40 31 Rash 37 35 24 Anemia 37 39 19 Insomnia 32 32 31 Diarrhea 28 32 22 Flu-like symptoms 28 29 28 Pyrexia 26 30 24
Side Effects of Telaprevir
• Skin rash
• Anemia
• Anorectal symptoms – Fire-rrhea
– Burning with defecation
– Begins within days of starting
– Topical corticosteroids, wipes (Tucks), Butt Paste,
Management of Anemia
• Assess patient – Symptomatic
– Patient with or without coronary artery disease • Erythropoietin- not allowed in clinical trials
• RBV dose reduction per package insert
– ? Less resistance to reduce RBV due to lack of effect on SVR
• Transfusions in severe cases
• No Telaprevir dose reductions/interruptions
– If RBV discontinued, Telaprevir must be d/c
Anemia - No effect on SVR in ADVANCE and ILLUMINATE
• Anemia associated with
SVR after PR therapy
• N=1239 in T12PR or PR • Hb <10 g/dL
– 41% (361/885) in T12PR – 26% (92/354) in PR
• RBV dose reductions for
anemia
– 72% (260/361) in T12PR – 58% (53/92) in PR
Sulkowski M, et al, EASL 2011, Berlin, P477
Neither anemia nor RBV dose reduction affected SVR with TVR. Apparent difference between TVR and BOC on impact of anemia on SVR requires further evaluation
RBV dose T12PR PR Reduction (%) 76 (243/320) 54 (37/69) No reduction (%) 72 (408/565) 41 (117/285)
Recommended Treatment Duration: Treatment Naïve and Prior Relapsers
Adapted from INCIVEKTM (Telaprevir) Product Monograph (Last revised: August 11, 2011); Vertex Pharmaceuticals Inc.
Recommended Treatment Duration:
Treatment Naïve and Prior Relapsers
Adapted from INCIVEKTM (Telaprevir) Product Monograph (Last revised: August 11, 2011); Vertex Pharmaceuticals Inc.
Recommended Treatment Duration:
Prior Partial and Null responders
Adapted from INCIVEKTM (Telaprevir) Product Monograph (Last revised: August 11, 2011); Vertex Pharmaceuticals Inc.
Futility Rules: All Patient Types
Patients with inadequate viral response are unlikely to achieve SVR. Discontinuation of therapy is recommended in all patients with:
(1) HCV-RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12;
or
(2) confirmed detectable HCV-RNA levels at Treatment Week 24.
Adapted from INCIVEKTM (Telaprevir) Product Monograph (Last revised: August 11, 2011); Vertex Pharmaceuticals Inc.
Major Predictors of Poor Adherence
• Patient and Treatment Factors
– Treatment of asymptomatic disease – Presence of psychological problems,
depression
– Subject’s lack of belief in benefit
– Complexity (incl. duration) of treatment – AE’s of Medication
Major Predictors of Poor Adherence
• Other Factors
• Poor Health Care Provider- Patient Communication
• Missed appointments
• Cost of Medication/deductible
63 52 51 34 0 20 40 60 80 100 All patients Genotype 1 patients PegIFN dose (%) Duration (%) RBV dose (%) ≥ 80 ≥ 80 ≥80 < 80 ≥ 80 < 80 P = .011 P = .04
Importance of Maintaining
80:80:80
62 51 34 SVR (%) 80/80/80 Wk 0-12 Remainder of trt Y Y Y N N N McHutchison JG, et al. Gastroenterology. 2002;123:1061-1069. Retrospective analysis of pegIFN alfa-2b/RBV phase trials
0 20 40 60 80 100
Hepatology Nurse is critical to
Adherence (100:100:100:100)
• Patient education is extensive
– Emphasize value of regimen and potential results to patients (eg SVR,RVR, IL28B)
– Duration of treatment
– Side effects – knowing what to expect
– Potential drug-drug interactions with protease inhibitors (check with nurse for all over- the -counter and prescription medications)
• Understanding of their treatment plan
– Provide simple, clear instructions and simplified regimen
– Customize regimen to patient lifestyle when possible
– Encourage use of a patient diary
• Nurse- patient communication established to support patient throughout treatment
Contraindications to BOC and TVR as Listed in
Prescribing Information*
1. Boceprevir [package insert]. May 2011. 2. Telaprevir [package insert]. May 2011.
Drug Class Contraindicated With BOC[1] Contraindicated With TVR[2]
Alpha 1-adrenoreceptor antagonist Alfuzosin Alfuzosin Anticonvulsants Carbamazepine, phenobarbital, phenytoin N/A
Antimycobacterials Rifampin Rifampin
Ergot derivatives Dihydroergotamine,
ergonovine, ergotamine, methylergonovine
Dihydroergotamine,
ergonovine, ergotamine, methylergonovine
GI motility agents Cisapride Cisapride
Herbal products Hypericum perforatum (St
John’s wort)
Hypericum perforatum
HMG CoA reductase inhibitors
Lovastatin, simvastatin Atorvastatin, lovastatin, simvastatin
Oral contraceptives Drospirenone N/A
Neuroleptic Pimozide Pimozide
PDE5 inhibitor Sildenafil or tadalafil when
Sildenafil or tadalafil when
Factors Associated With Previous HCV
Treatment
Failure - UnModifiable Factors
•
Genotype
•
HCV RNA
•
Stage of Liver Disease
•
Age
•
Patient Sex
Factors Associated With Previous HCV
Treatment Failure - Modifiable Factors
• Weight
• Steatosis
• Drug exposure/adherence
• Mental Health Issues
• Substance use
• Regular monitoring for virologic response
Effective AE management Resource identification: financial and psychosocial Increased adherence, which results in effective treatment Appropriate patient education and support Active collaboration with health care professionals
(hepatologist, hepatology nurses,dermatologist, psychiatrist, infectious disease specialist)
Multidisciplinary Approach to HCV
Treatment
History – Pt KKK
• 52 year old male (electrician)
• Diagnosed May 2008 (annual physical)
• No IVDU, cocaine, MVA in early 20’s, no tattoos
• Mild fatigue (needs a nap at the end of the day)
• Generally feels well
• No ETOH since diagnosis
• Weight 105 kg
History – Pt KKK
• Genotype 1a
• Viral load at Baseline 3,900,000 IU/ml • Normal CBC
– (HGB 14.9, Neutrophils 3.36, Platelets 263)
• ALT 91, AST 52
• Normal coags and normal TSH
• Abdominal Ultrasound shows mild fatty infiltration of the liver
Adverse Events
• Week 2
– Overall doing well – Fever and chills – Fatigue
– Cough and SOBOE – Injection site redness • Week 4
– Normal Physical Assessment • Other Adverse Events
– Alopecia – Dry mouth – Irritability
Blood work
Week 8 Week 20 HgB 11.4 HgB 10.5 Neutrophils 1.67 Neutrophils 1.43 Platelets 241 Platelets 235 ALT 24 ALT 22 AST 23 AST 24Viral Load Counts
Name: KKK
Week Viral Load
HCV Quantitative PCR
Screening 2,200,000
Baseline Day 1 3,900,000
Week 2 17,500
Week 4 957
Week 6 No HCV RNA Detected
Week 8 No HCV RNA Detected
Week 10 No HCV RNA Detected
Week 12 No HCV RNA Detected
Week 16 No HCV RNA Detected
Week 20 No HCV RNA Detected
Week 24 No HCV RNA Detected
Viral Load Counts
Name: KKK
Week Viral Load
HCV Quantitative PCR Week 34 Week 40 Week 48 FU Week 4 FU Week 12 FU Week 24
DC FU Week 4 No HCV RNA Detected
DC FU Week 12 No HCV RNA Detected
Viral Load Counts
Name: KKK
Your medication dosages:
PegIntron (injection): 150 mcg.( 0.5 ml) by injection once a week Your injection day is every __Friday___
Ribavirin capsules 1200mg (6 pills) every day (take with food): (3 pills at breakfast, 3 pills at dinner)
Boceprevir (Starts at week 4): Start Date: __31-Oct-08__ Boceprevir Dose: 800mg TID (4 tablets, 3 x per day) every 8
hours (7-9 hours is ok but every 8 hours is preferred; take with food)(4 pills at breakfast (eg. 07:00), 4 pills at 3:00, 4 pills at 10:00pm (with food).)
Insert times for doses: ______am_______ pm______pm
NOTE: Take all doses on time each and every day. ‘Take with food’ means a small snack, fruit or crackers.
Month: ___________ Year: _________ Date, dd/mmm/yyyy (To be completed by Patient) BOC
# Capsules Taken per day (Start Recording at Week 4)
RBV
# Capsules Taken per day
RECORD ONCE WEEKLY
*PEG strength volume AM: ____ Midday:____ PM:____ Total # capsules _____ AM: ______ PM: ______ Total # capsules ______ ___ 50 mcg ___ 80 mcg ___ 120 mcg ___ 150 mcg ____ mL AM: ____ Midday:____ PM:____ Total # capsules _____ AM: ______ PM: ______ Total # capsules ______ ___ 50 mcg ___ 80 mcg ___ 120 mcg ___ 150 mcg ____ mL AM: ____ Midday:____ PM:____ Total # capsules _____ AM: ______ PM: ______ Total # capsules ______ ___ 50 mcg ___ 80 mcg ___ 120 mcg ___ 150 mcg _____ mL AM: ____ Midday:____ PM:____ Total # capsules _____ AM: ______ PM: ______ Total # capsules ______ ___ 50 mcg ___ 80 mcg ___ 120 mcg ___ 150 mcg _____ mL
Boceprevir (BOC) capsules
Should be taken with food 3x a day every 7 – 9 hours
Ribavirin (RBV) capsules
Should be taken with food 2x a day
*Peginterferon (PEG) Redipen
Injection 1x a week, Rotate Injection Sites
Physician: Dr. _________________ Patient Name: __________________ ______________________________
History – Pt EV
•
60 year old male caucasian
•
Genotype 1a naïve
•
Liver Biopsy stage 3 fibrosis
•
85 Kgm
•
Cocaine use – 5 years ago
Pt EV
•
Treatment initiated:
-Telaprevir 750 mgm TID
-Pegasys 180 mcq
-Ribavirin 1200 mg/daily
•
Baseline viral load – 1,004,265 iu/ml
•
Hgb 145 ALT 175 plt 200 neuts 2.0
•
Shortened treatment – 24 weeks
20 gm of Fat
•
½ cup nuts (almonds)
•
2 ounce cheddar cheese
•
3 tbsp peanut butter
•
Bagel with cream cheese
•
1 medium blueberry muffin
•
1cup of milk (8 gm)
•
6 oz salmon filet- (21gm)
Pt. EV Rash
•
Macular-papular drug eruption < 50% BSA
•
No mucous membranes involvement
•
Pruritus to upper and lower back
•
Initial treatment – Hydrocortisone d/c
The “Telaprevir Rash”
• More than 90% of rashes mild-to-moderate, intensely pruritic and/or painful • Rash was primarily eczematous and resolved upon cessation of therapy • Distributed over chest, extremities, back
• Counsel patients that rash is possible, assure them that it is manageable
• Important to start steroid cream ASAP
• Results in treatment d/c in small number of patients
• Moderate and severe rash were managed by sequentially discontinuing telaprevir, followed by ribavirin after 7 days and, if indicated,
peginterferon for continued progression
• Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) and Stevens-Johnson reported <1%
Rash Management
• Low dose steroid topical cream, oral antihistamines
• Good hydration
• Avoid sunburns
– Increased derm photosensitivity with RBV
– Sunblock, long sleeves/pants, avoid peak sun
• Keep skin moisturized
– Aveeno, Eucerin, Aquaphor
• No bar soap, oatmeal products
Compliance Benefit of Response-Guided
Treatment with Protease Inhibitors
• Duration of treatment potentially shortened with Protease Inhibitors in comparison to Standard of Care (SOC) should facilitate health care provider management
• Motivation for patients to be treated only 24 -28 weeks which should improve patient
adherence with the opportunity for significantly improved results.
• The adverse events of Protease Inhibitors are not appreciably different than those receiving SOC
Impact of Boceprevir and Telaprevir
• Protease Inhibitors offers greatly enhanced SVR
• SVR is critical
• New standard of care has been set
• G1 naïve and treatment failure patients (both
non-responders and relapsers) better with
Impact of Boceprevir and Telaprevir
• The Hepatology Nurse is critical to the
achievement of patient Adherence and to higher
SVR rates
• Keep it Simple for patients
• Pill Burden – strategies to manage
• Communication is critical
Impact of Protease Inhibitors - Challenges on
Practice
• Time intensive
-Pretreatment - education
- Management during treatment (adverse events)
• Access to treatment
- Criteria for pharmacare access - HCV RNA testing availability
- Access to Fibroscan, Growth Factors
• Education of both health care providers and patients will
be required to allow for successful treatment of patients
Black Tusk … We have reached the summit the hardest part of the climb and a cure for all is in sight
