NEW THERAPIES AND DIFFICULT TO TREAT PATIENTS: HCV PD Dr. D. - - PowerPoint PPT Presentation
NEW THERAPIES AND DIFFICULT TO TREAT PATIENTS: HCV PD Dr. D. - - PowerPoint PPT Presentation
NEW THERAPIES AND DIFFICULT TO TREAT PATIENTS: HCV PD Dr. D. Nierhoff University of Cologne NEW NEW SINCE AREVIR MEETING 2017 NEW THERAPIES (SINCE AREVIR MEETING 2017) Maviret Vosevi NEW THERAPIES (SINCE AREVIR MEETING 2017)
NEW
NEW
SINCE AREVIR MEETING 2017
NEW THERAPIES
(SINCE AREVIR MEETING 2017)
- Maviret
- Vosevi
NEW THERAPIES
(SINCE AREVIR MEETING 2017)
- Maviret
- Vosevi
pangenotypic, first line
NEW THERAPIES
(SINCE AREVIR MEETING 2017)
- Maviret
- Vosevi
pangenotypic, first line
Epclusa
(
Harvoni, Zepatier GT 1&4, first line Old
)
New
NEW THERAPIES
(SINCE AREVIR MEETING 2017)
- Maviret
- Vosevi
pangenotypic, first line pangenotypic, second line
Epclusa
(
Harvoni, Zepatier GT 1&4, first line Old
)
REAL WORLD
WITH PANGENOTYPIC THERAPIES
REAL-WORLD WITH GP
REAL-WORLD WITH GP
REAL WORLD WITH SV
REAL-WORLD WITH SVV
DIFFICULT TO TREAT PATIENTS?
Choice of best treatment Time point of treatment Caution during treatment No licensed treatment
DIFFICULT TO TREAT PATIENTS?
- Relapser
- Genotype 3 and LCI
Choice of best treatment
DIFFICULT TO TREAT PATIENTS?
- Relapser
- Genotype 3 and LCI
Choice of best treatment
Only Vosevi available!
100
ASTRAL-3 OPEN-LABEL TRIAL: SVR12, SAFETY WITH SOFOSBUVIR/VELPATASVIR IN GT3 HCV
Mangia A, et al. AASLD 2015. Abstract 249. Reproduced with permission. Foster GR, et al. N Engl J Med. 2015;[Epub ahead of print]. n/N =
SVR12 (%) 80 60 40 20
264/2 77 221/2 75 191/1 97 163/1 87 73/ 80 55/ 83 200/ 206 176/ 204 64/ 71 45/ 71
95 80 63 90 97 97 87 91 66 86 All Pts No Yes Naive Experienced Cirrhosis P < .001
(superiority)
SOF/VEL 12 wks SOF + RBV 24 wks
Slide credit: clinicaloptions.com
Treatment History
NEW EASL GUIDELINE 2018
GT3 WITH LCI SOF/VEL +/- RBV
GT3 WITH LCI SOF/VEL +/- RBV
GT3 WITH LCI SOF/VEL +/- RBV
IF A PROBLEM WITH RBV …
WITH REGARD TO PRICE …
Price (AVP) SV 12 W + RBV 34.957,44 + ca. 2.000 GP 12 (naive)- 16 W (experienced)
(KI for RBV)
52.436,16 - 69.914,88 SVV 8W (second line) 44.521,76
DIFFICULT TO TREAT PATIENTS?
- Relapser
- Genotype 3 and LCI
Choice of best treatment
2 options and a backup: Just a matter of price or RBV.
DIFFICULT TO TREAT PATIENTS?
- Decompensated liver cirrhosis
- Patients with HCC
Time point of therapy
Waiting list for liver Tx 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Germany 1948 2163 2161 2119 1868 1534 1351 1280 1157 1086
INCIDENCE OF NEW HCC
No evidence for differential occurrence of HCC following SVR from DAA and IF.-based
- therapy. Waziry et al., J Hepatol 2017
RECURRENT HCC
No evidence for differential recurrence of HCC following SVR from DAA and IF.-based
- therapy. Waziry et al., J Hepatol 2017
DIFFICULT TO TREAT PATIENTS?
- Decompensated liver cirrhosis
- Patients with HCC
Time point of therapy
Rare Probably no harm to treat these patients, but maybe not helpful, if no LTx option.
DIFFICULT TO TREAT PATIENTS?
- HBV
- Chronic kidney injury
Caution during treatment
Reaktivierung von Anti-HBc only unter DAA-Therapie!
DIFFICULT TO TREAT PATIENTS?
- HBV
- CKI
Caution during treatment
If problems exists, it is rare. Check viral load during therapy.
SOF-BASED DAA WITHOUT IFN IS A RISK FACTOR FOR EGFR DECREASE: GIVE WITH CAUTION AMONG PATIENTS AT RISK OF RENAL PROGRESSION
- Linear mixed model of eGFR variations in a 2013–2016 monocentric retrospective
- bservational cohort of 814 CHC patients
- Median (IQR) age: 58 (52–66) years; 40% cirrhosis; 25% CKD risk factors
Without CKD risk factors With CKD risk factors
Mean (95% CI) eGFR, ml/min/1.73 m2
Before DAA (n=421; 1,266 measures) At DAA (n=740; 740 measures) Under DAA (n=640; 929 measures) After DAA (n=503; 1,040 measures) Median (IQR): 107 (340) wks Median (IQR): 24 (17) wks Before DAA (n=41; 100 measures) At DAA (n=74; 73 measures) Under DAA (n=64; 59 measures) After DAA (n=46; 71 measures) Median (IQR): 92 (204) wks Median (IQR): 23 (12) wks p=0.124 p=0.735 REF REF p=0.11 p=0.225 p=0.745 p=0.663
87 97 92 82 77
p<0.001 p=0.582 p=0. 945 REF REF p<0.001 p=0.122 p=0.014
90 96 94 92 86 84 88 82 72
eGFR variations among 740 CHC patients exposed to SOF-based DAA treatment eGFR variations among 74 CHC patients exposed to non-SOF-based DAA treatment
Mean (95% CI) eGFR, ml/min/1.73 m2
Linear mixed models of eGFR were stratified by CKD risk factors with SOF exposure as a fixed factor and with adjustments for baseline patient demographics and clinical characteristics Mallet V, et al. ILC 2018, #PS-037
DIFFICULT TO TREAT PATIENTS?
- HBV
- CNI
Caution during treatment
If problems exists, it is rare. Check viral load during therapy. If problems exists, it is mild. Check GFR during therapy.
DIFFICULT TO TREAT PATIENTS?
- Children < 12 years
- Acute hepatitis C
No licensed treatment
DIFFICULT TO TREAT PATIENTS?
- Children < 12 years
- Acute hepatitis C
No licensed treatment
DIFFICULT TO TREAT PATIENTS
Choice of best treatment Time point of treatment Caution during treatment No licensed treatment
GT 3 and LCI Relapser Patients with HCC
- Decomp. LCI
HBV CKI Acute hepatitis Children < 12y