| Abbreviation |
Expansion or Notes |
|
| These terms are not expanded in text |
| HCV |
hepatitis C virus. In this Guidance “hepatitis C virus” and HCV refer to the virus. Hepatitis C and HCV infection or HCV disease refer to the resulting disease. |
| IFN |
interferon alfa |
| PEG |
peginterferon alfa |
|
| These terms are expanded at first mention in text |
| ALT |
alanine aminotransferase |
| AST |
aspartate aminotransferase |
| AUC |
area under the curve |
| BOC |
boceprevir |
| CBC |
complete blood cell (eg, complete blood cell count) |
| CrCl |
creatinine clearance |
| CTP |
Child Turcotte Pugh (see below) |
| DAA |
direct-acting antiviral |
| eGFR |
estimated glomerular filtration rate |
| ESRD |
end-stage renal disease |
| FDA |
Food and Drug Administration |
| GFR |
glomerular filtration rate |
| HBsAg |
hepatitis B virus surface antigen |
| HBV |
hepatitis B virus |
| HCC |
hepatocellular carcinoma |
| IDU |
injection drug use or user |
| INR |
international normalized ratio |
| MELD |
model for end-stage liver disease |
| MSM |
men who have sex with men |
| NAT |
nucleic acid testing |
| NIH |
National Institutes of Health |
| OATP |
organic anion-transporting polypeptide |
| P-gp |
p-glycoprotein |
| PrOD |
paritaprevir/ritonavir/ombitasvir plus dasabuvir |
| RAS |
resistance-associated substitution |
| RBC |
red blood cell (eg, red blood cell count) |
| RBV |
ribavirin |
| RGT |
response-guided therapy |
| RVR |
rapid virologic response |
| sAg |
surface antigen |
| SMV |
simeprevir; used for the treatment of those with genotype 1 of hepatitis C virus (HCV) who have compensated liver disease, including cirrhosis |
| SOF |
sofosbuvir; a nucleoside analogue used in combination with other drugs for the treatment of HCV infection |
| SVR12 (or 24 or 48, etc) |
sustained virologic response at 12 weeks (or at 24 weeks, or at 48 weeks, etc) |
| TSH |
thyroid-stimulating hormone |
| TVR |
telaprevir; an antiviral agent to treat hepatitis C |
|
|
|
| Child Turcotte Pugh (CTP) classification of the severity of cirrhosis |
|
Class A |
Class B |
Class C |
| Total points |
5–6 |
7–9 |
10–15 |
| Factor |
1 Point |
2 Points |
3 Points |
| Total bilirubin (µmol/L) |
<34 |
34–50 |
>50 |
| Serum albumin (g/L) |
>35 |
28–35 |
<28 |
| Prothrombin time/international normalized ratio |
<1.7 |
1.71–2.30 |
>2.30 |
| Ascites |
None |
Mild |
Moderate to Severe |
| Hepatic encephalopathy |
None |
Grade I–II (or suppressed with medication) |
Grade III–IV (or refractory) |
|
| IFN ineligible |
IFN ineligible is defined as one or more of the below:
- Intolerance to IFN
- Autoimmune hepatitis and other autoimmune disorders
- Hypersensitivity to PEG or any of its components
- Decompensated hepatic disease
- Major uncontrolled depressive illness
- A baseline neutrophil count below 1500/µL, a baseline platelet count below 90,000/µL or baseline hemoglobin below 10 g/dL
- A history of preexisting cardiac disease
|
| Relapser |
a person who has achieved an undetectable level of virus during a prior treatment course of PEG/RBV and relapsed after treatment was stopped |
|
Changes made September 16, 2016.