HCV

Lab Results before Referral

Complete Lab Testing - Steps 2 & 3

If the HCV diagnosis is confirmed by an

HCV RNA PCR quantitative (viral load) test, proceed directly to Step #3 and order the remaining lab tests before referral.

Steps #2 & #3 are needed before referral.

Step #2

- Order an HCV antibody (Ab) with reflex to HCV RNA PCR Quantitative (viral load)

- If the HCV Ab is negative, no referral is needed.

- If the HCV Ab is positive but the HCV RNA Quantitative is not detected, no referral is needed.

- If the HCV RNA Quantitative is > 15 IU/mL (1.18 log IU/mL), then go to Step #3

Step #3

order the remaining lab tests, and
after the lab results are available, then refer the patient to HRA with their medical records

Remaining Lab Orders:

CBC with platelets
CMP with hepatic function and eGFR
INR
HBV panel
- HBsAG - Hepatitis B Surface Antigen with Reflex to Confirmation
- HBcAb (Anti-HBc) - Hepatitis B Core Antibody (Total or IgG)
- HBsAb (Anti-HBs) - Hepatitis B Surface Antibody, Quantitative (if available)
HIV-1/2 antigen-antibody test
HCV genotype
FibroSure
Abdominal Ultrasound

*Resistance-associated substitutions (RAS) - (only needed if the patient has been previously treated)

*Serum pregnancy test if needed

*Urine testing for STDs (Gonorrhea & Chlamydia) - Arkansas Dept. of Health screening

*Syphilis - Arkansas Dept. of Health screening

*Only needed if relevant.

HCV Lab Tests List- PDF

Quest Diagnostic - HCV Lab Panel - PDF

Complete the HCV Data Checklist before referral to HRA

HCV Data Checklist - PDF

...THEN REFERRAL TO HRA

Contact HRA - call (501) 940-5352 -or- email (DrH@HRA.team)

Referral and Medical Records

Click on the following Document Portal link to submit all referral documents (including all lab results and the HCV Data Checklist).

Document Portal

Patient Handout at Time of Referral - PDF

Interpreting HCV RNA Qauntitative Test Results

Interpretation Summary

Any Viral Load: equal to or > 15 IU/mL (1.18 log IU/mL) should be treated.
- Low Viral Load: < 800,000 IU/mL (less than 5.9 log IU/mL)*
- High Viral Load: > 800,000 IU/mL (greater than 5.9 log IU/mL)*

The quantification range is 15 IU/mL (1.18 log IU/mL) to 100,000,000 IU/mL (8.00 log IU/mL).

If a quantitative HCV RNA result is reported as "<15 IU/L (1.18 log IU/mL)," this means that the quantitative test cannot measure the hepatitis C virus, which means the patient does not have an active infection. (aka, Not Detected)

Explanation

The quantitative HCV RNA test is checked before a patient starts treatment.

For each patient, the result can be described as either a "high" viral load, which is usually >800,000 IU/L, or a "low" viral load, which is usually <800,000 IU/L. The quantification range of this assay is 15 to 100,000,000 IU/mL (1.18 log to 8.00 log IU/mL). It's not uncommon to have a viral load in the millions. Today's hepatitis C treatments are very effective with both high and low viral loads. An undetectable HCV viral load 10-12 weeks after hepatitis C is completed is associated with a cure.

The quantitative HCV RNA test is used to determine the success of treatment.

The response to treatment is considered good when the quantitative HCV RNA measurement drops and the virus eventually becomes completely undetectable.

It is not necessary to check the viral load repeatedly during treatment.
The viral load measurement does not tell us anything about the severity of a patient's liver disease or the degree of fibrosis (scarring). For that information, the patient would need additional testing.
If a quantitative HCV RNA result is reported as "<15 IU/L," this means that the quantitative test cannot measure the hepatitis C virus. It may mean that there is no detectable HCV RNA at all, but it may mean that the level of virus is just too low for the test to pick it up.

In the context of Hepatitis C Virus (HCV) RNA quantitative testing, viral load is measured in international units per milliliter (IU/mL). Here’s a comparison between low and high viral loads:

Low Viral Load

High Viral Load

Log IU/mL

Conversion: Viral loads are sometimes expressed in logarithmic scale (log IU/mL) to simplify the representation of large numbers. For example, a viral load of 1,000,000 IU/mL is equivalent to 6 log IU/mL. *

Summary

Low Viral Load: < 800,000 IU/mL (less than 5.9 log IU/mL)*
High Viral Load: > 800,000 IU/mL (greater than 5.9 log IU/mL)*
The limit of quantification for this RNA assay is 15 IU/mL (1.18 log IU/mL). If the assay DETECTED the presence of the virus but was not able to accurately quantify, the test will be reported as "Not Quantified, Detected."

*(Explanation: The difference between log values of 5.9 and 6 on a logarithmic scale represents a tenfold change. Specifically, a log value of 5.9 corresponds to approximately 794,328 IU/mL, while a log value of 6 corresponds to 1,000,000 IU/mL So, the difference is about 205,672 IU/mL.)

References:

Six Month Rule - Repeat HCV RNA Quantitative Test

Retesting HCV RNA quantitatively is recommended if the previous positive test is over 6 months old. If the previous test was negative, retesting is important if there is a suspicion of recent HCV exposure, clinical evidence of HCV disease, or concerns about the handling or storage of the previous test specimen.

If the previous viral load demonstrated active disease it is important to confirm if a spontaneous cure has occurred. Spontaneous clearance of HCV can happen in a small percentage of people, typically within the first 6 months of infection. Retesting helps to determine if the virus is still present or if the body has cleared it on its own.

Other timing considerations:

If an HCV antibody test is not reactive/positive, the patient has not been exposed and you can rule out infection.
For acute HCV infection, it usually takes 8–11 weeks before antibodies are detectable.
If the antibody test is reactive/positive, you will still need to test for HCV RNA to diagnose the patient and start treatment.
It usually takes 1–2 weeks after exposure to the virus for detectable HCV RNA levels to appear.
New guidance from CDC in July 2023 recommends complete, automatic HCV RNA testing on all HCV antibody reactive samples to minimize patient visits and increase the number of patients diagnosed and treated.