[Date]
[Insurance Company]
[Address 1]
[Address 2]
[City State Zip]
Re: [Patient Name]
Insurance ID: [ID #]
DOB: XX/XX/XXXX
To whom it may concern,
I am writing on behalf of my patient to recommend testing for genetic variants associated with treatment response
for chronic genotype 1 hepatitis C virus (HCV-1) infection and decreased hemolytic side effects from HCV antiviral therapy. Side effects of peginterferon (PEG-IFNα) and ribavirin (RBV) combination therapy for HCV
include RBV-induced hemolytic anemia, flu-like symptoms, and adverse neuropsychiatric events. An estimated
10-20% of patients experience treatment-related hemolytic anemia requiring dose modifications, and 10-15% of
patients require discontinuation of therapy due to side effects. Given the high cost of chronic HCV treatment and
the possibility of adverse side effects, pre-therapeutic identification of factors predicting response is helpful in
estimating the likelihood of a sustained virological response (SVR).
Two variants in the interleukin 28B (IL28B) gene region, rs12979860 and rs8099917, have been independently
associated with response to PEG-IFNα/RBV therapy. Individuals with chronic HCV-1 infection with the
rs12979860 C/C genotype or the rs8099917 T/T genotype have greater rates of SVR following treatment and
higher rates of natural clearance of HCV.
Two variants in the inosine triphosphatase (ITPA) gene, rs1127354 and rs7270101, are associated with inosine
deficiency and protection against RBV treatment-related anemia in patients with HCV genotypes 1, 2, or 3. The
following genotypes are considered protective: rs1127354 A/A and A/C; rs727010 C/C and C/A.
Because of these factors, I am recommending genetic testing for the two variants in IL28B and ITPA for my
patient. Please note that this test is performed for clinical management in a laboratory that is CLIA approved for
high complexity testing.
Authorization should be obtained for:
Test name: [Test name]
Facility: ARUP Laboratories
CPT codes: [CPT codes]
Diagnosis code: [Diagnosis code]
Thank you for your time and attention to this matter.
Sincerely,
From www.aruplab.com
Revision 1
Created: 02/22/2013
[Name of Ordering Physician]
References:
1. Ge D. et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature. 2009; 461(7262):399-401.
2. Suppiah V. et al. IL28B is associated with response to chronic hepatitis C interferon-α and ribavirin therapy. Nat Genet. 2009;
41(10):1100-1104.
3. Fallay J. et al. ITPA gene variants protect against anaemia in patients treated for chronic hepatitis C. Nature. 2010; 484(7287):405-408.
From www.aruplab.com
Revision 1
Created: 02/22/2013