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

Question 1What to do next?

• A- Treat Now• B- Wait• C- Wait and perform LB in 5 years

Abbvie

2014-2015

Abbvie

DAA II -3MonthsIFN free

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

Abbvie

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

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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%)

Thank you for attention