Clinical case study - · PDF fileClinical case study Abbvie symposium ... Slide courtesy Chia...
Transcript of Clinical case study - · PDF fileClinical case study Abbvie symposium ... Slide courtesy Chia...
Clinical case studyAbbvie symposium
1st Algerian Liver Day
Clinical case studyAbbvie symposium
1st Algerian Liver DayNabil DEBZI
Hepatology DepartmentMustapha Hospital
Algiers
Abbvie
Clinical case• 2/2000
Man 50 years oldNo Alcohol , No tobacco , BMI 23No abnormalities on physical examinationLab tests : HCV ab positive , ALT 12, INR 3.2, Albumin 4.1 ,HCV RNA positive , G1 ,Liver Biopsy : A1F1 Metavir scoring system
• Previous history- 1958 : Pleurodesis for Tuberculosis- 1997 : Heart operation ( valve replacement)vit K antagonists- 1999 : Laparoscopic Cholecystectomy
• 2/2000Man 50 years oldNo Alcohol , No tobacco , BMI 23No abnormalities on physical examinationLab tests : HCV ab positive , ALT 12, INR 3.2, Albumin 4.1 ,HCV RNA positive , G1 ,Liver Biopsy : A1F1 Metavir scoring system
• Previous history- 1958 : Pleurodesis for Tuberculosis- 1997 : Heart operation ( valve replacement)vit K antagonists- 1999 : Laparoscopic Cholecystectomy
Abbvie
Question 1What to do next? in 2000
• A- Treat Now• B- Wait• C- Wait and perform LB in 5 years
Abbvie
1/2014
• Fatigue• Physical examination : good condition• ALAT 1,5 N , INR 3.5, Bilirubine N , platelets
count 220.000/mm 3 HCV RNA 6,2 log , G 1b ,• LB TJ 2013 : A1F2
• Fatigue• Physical examination : good condition• ALAT 1,5 N , INR 3.5, Bilirubine N , platelets
count 220.000/mm 3 HCV RNA 6,2 log , G 1b ,• LB TJ 2013 : A1F2
Abbvie
Question 2wich regimen ?
• A-Peg IFN + RBV• B-Peg IFN +RBV+ PI 1st generation• C- IFN+RBV+SOF• D- SOF+SMV
• A-Peg IFN + RBV• B-Peg IFN +RBV+ PI 1st generation• C- IFN+RBV+SOF• D- SOF+SMV
Abbvie
Question 2wich regimen ?
• A-Treat with Peg IFN +RBV• B-Treat with Peg IFN+RBV+PI 1st generation• C- Treat with Peg IFN+RBV+SOF• D- SOF+SMV
• A-Treat with Peg IFN +RBV• B-Treat with Peg IFN+RBV+PI 1st generation• C- Treat with Peg IFN+RBV+SOF• D- SOF+SMV
Abbvie
National Cohort 2012 (n = 734)Dual therapy SVR
400
500
61.9 % n = 454
Failure = 38% n = 280
0
100
200
300
400
National cohort 2012 n = 734SVR according to genotype
50607080
59%n = 3141b > 1a
n = 100 n = 33 n = 6 n = 1
01020304050
G1 G2 G3 G4 G5
IP Results n = 58 ( BOC 43 , TVR 15)F3F4 (n=32) CUPIC (-)
Relapsers 58.6% (n=34), Partials responders 6.9%(n=4) NR 29.3% (n=17) , Naive ( n=3)
32 (26) complete therapy : 20 BOC , 6 TVRintolerance ( BOC 1,TVR 3)
83% TVR61.5%
N.AFREDJ 2015
55% BOC
He refused Dual Therapythe Hater of Interferon
• Depression rangingfrom mild to suicidality• Irritability, aggressivebehavior• Worsening of mania• Fatigue• Insomnia• Myalgias, fever, flu-likesymptoms• Hair loss• Cytopenias
• Depression rangingfrom mild to suicidality• Irritability, aggressivebehavior• Worsening of mania• Fatigue• Insomnia• Myalgias, fever, flu-likesymptoms• Hair loss• Cytopenias
“Interferon Man”Slide courtesy Chia Wang
Abbvie
1/2015 Good Financial conditionQuestion 3 Wich regimen ?
• A - SOF + SMV• B - SOF + LDV• C - OMV/PTV/RTV + DSV
Abbvie
1/2015Question 3 Wich regimen ?
still hater of IFN
• A - SOF + SMV• B - SOF + LDV• C - OMV/PTV/RTV + DSV
• A - SOF + SMV• B - SOF + LDV• C - OMV/PTV/RTV + DSV
Abbvie
Phase III Studies: SOF/LDV FDC± RBVin GT1 Pts
SOF/LDV + RBV (n = 217)
SOF/LDV (n = 214)
Wk 24
ION-1[1]
Treatment-naiveGT1 HCV;
cirrhosis in 15%to 17% per arm
(N = 865) SOF/LDV + RBV (n = 217)
SOF/LDV (n = 217)
Wk 12 SVR12, %
99
97
98
99
Wk 8
1. Afdhal N, et al. N Engl J Med. 2014;370:1889-1898. 2. Afdhal N, et al. N Engl J Med. 2014;370:1483-1493.3. Kowdley KV, et al. N Engl J Med. 2014;370:1879-1888.
SOF/LDV + RBV (n = 111)
SOF/LDV (n = 109)ION-2[2]
Treatment-experienced
GT1 HCV; 20%cirrhotics(N = 440) SOF/LDV + RBV (n = 111)
SOF/LDV (n = 109)
94
96
99
99
SOF/LDV + RBV (n = 216)
SOF/LDV (n = 215)ION-3[3]
Treatment-naive,noncirrhotic ptswith GT1 HCV
(N = 647) SOF/LDV (n = 216)
94
93
95
Abbvie
2/7th /2015
• We start Harvoni ®Fibroscan : 8,2 Kpa , HCV RNA 6.6 logWeek 4- 3/11th /2015 :HCV RNA undetectableGood Tolerability ( chest oppression and hotflashes )Week 12 : today (I’m waiting SMS)
• We start Harvoni ®Fibroscan : 8,2 Kpa , HCV RNA 6.6 logWeek 4- 3/11th /2015 :HCV RNA undetectableGood Tolerability ( chest oppression and hotflashes )Week 12 : today (I’m waiting SMS)
Abbvie
Question 4 -If our patient is cirrhoticWich option you choose ?
• A - Viekierax ® Exviera ®+ RBV 12 weeks• B - Viekierax ® Exviera ® 12 weeks• C - Harvoni ® 24 weeks• D - Harvoni ® + RBV 12 weeks
• A - Viekierax ® Exviera ®+ RBV 12 weeks• B - Viekierax ® Exviera ® 12 weeks• C - Harvoni ® 24 weeks• D - Harvoni ® + RBV 12 weeks
Abbvie
Question 4 If our patient is cirrhoticWich option you choose
• A - Viekierax ® Exviera ® + RBV 12 weeks• B - Viekierax ® Exviera ® 12 weeks• C - Harvoni ® 24 weeks• D - Harvoni ® + RBV 12 weeks
• A - Viekierax ® Exviera ® + RBV 12 weeks• B - Viekierax ® Exviera ® 12 weeks• C - Harvoni ® 24 weeks• D - Harvoni ® + RBV 12 weeks
Abbvie
FDA-Approved All-Oral Regimens forGT1
Population Regimen Duration
GT1, TN or TE, noncirrhotic SMV + SOF[1] 12 wks
GT1, TN or TE, cirrhotic SMV + SOF[1] 24 wks
GT1 interferon ineligible SOF + RBV[2] 24 wks*
GT1, TN SOF/LDV[3] 12 wks†
GT1, TE, noncirrhotic SOF/LDV[3] 12 wksGT1, TE, noncirrhotic SOF/LDV[3] 12 wks
GT1, TE, cirrhotic SOF/LDV[3] 24 wks
GT1a, TN or TE, noncirrhotic OMV/PTV/RTV + DSV + RBV[4] 12 wks
GT1a, TN or TE, cirrhotic OMV/PTV/RTV + DSV + RBV[4] 24 wks‡
GT1b, TN or TE, noncirrhotic OMV/PTV/RTV + DSV[4] 12 wks
GT1b, TN or TE, cirrhotic OMV/PTV/RTV + DSV + RBV[4] 12 wks
1. Simeprevir [package insert]. 2. Sofosbuvir [package insert]. 3. Sofosbuvir/ledipasvir [package insert].4. Ombitasvir/paritaprevir/ritonavir and dasabuvir [package insert].
*Not recommended per AASLD/IDSA guidance.†8-wk course can be considered in pts without cirrhosis with pretreatment HCV RNA < 6 million IU/mL.‡12-wk course may be considered for some patients based on previous treatment history.
Abbvie
End of Treatment Response (EOTR): 60/60 (100%)
SVR4 Response to Date: 41/41 (100%)SVR12 Response to Date: 6/6 (100%)