Wednesday, May 21, 2014

Case of the Month: Hepatitis C and the Risk of Treatment Failure

Case of the Month Special Edition: Hepatitis C and the Risk of Treatment Failure
Posted on May 20, 2014
by Halley Cornell
in Case of the Month

In honor of National Hepatitis Awareness Month, the CCC is sharing a case from its CCC VA Hepline. The Hepline is currently a service for medical providers at U.S. Department of Veterans Affairs institutions and clinics only. 

Case Summary
An infectious disease clinician called about a 44-year-old patient with a history of injection drug use who had been diagnosed one year earlier with hepatitis C genotype 1a. The patient had presented to the calling clinician with nausea and vomiting and had transaminases (AST/ALT) in the 500s with otherwise normal labs. A hepatitis C antibody test was positive, with ahepatitis C RNA PCR of 10 million. A liver biopsy result showed Grade 2, Stage 3 fibrosis.

Four weeks prior to the consultation call, the patient had started ribavirin, pegylated interferon and sofosbuvir, which he had been tolerating well. However, about 2 weeks into the treatment, the patient developed a fever and cough and was diagnosed with Mycoplasma pneumonia, which was treated with azithromycin. Four weeks into treatment, liver function tests had normalized, the patient’s hemoglobin was relatively stable at 12.7 (decreased from 13.8 pre-treatment). The hepatitis C viral load had decreased from 10 million IU/ml to 199 IU/ml.

The caller was concerned about the risk of treatment failure, as the hepatitis C viral load was still detectable after 4 weeks of treatment. She asked if response-guided therapy with sofosbuvir-based regimens was recommended, and also asked if the patient’s persistent HCV viremia could be due to the concurrent pneumonia.
CCC Consultant Advice

At the CCC VA HepLine, consultants do not recommend response-guided therapy for sofosbuvir regimens. Continuing the current treatment in this patient is recommended. The FDA, AASLD, and other sources do not recommend response-guided therapy with sofosbuvir-based regimens. In all previous clinic trials, therapy was continued – even with ongoing HCV viremia – with excellent outcomes. In this patient who has shown clinical improvement, there is a compelling argument to continue treatment; however, this case raises important issues about how we translate data from small clinical trials to our clinical practice with patients who may not be adherent.

As one CCC consultant stated, “This is the kind of case that the entire HCV treating community is struggling with, because not many patients in clinical trials behaved like this, but in the real world, of course, sometimes they do. I fundamentally agree with telling the caller to continue therapy. The bottom line is that if an experienced treating clinician feels that a patient can tolerate a sofosbuvir-containing regimen, it can be continued until later time-points, but likely a 6-week VL and an 8-wk VL can be obtained to assess whether the patient is ‘failing’ the regimen or not. There are no stopping rules for sofosbuvir-containing regimens. There are, however, patients who are failing a regimen (due to non-compliance or relapse) who may be at risk for developing sofosbuvir resistance. No one really knows where the ‘line’ is for stopping an SOF-containing regimen.”

Finally, for other chronic viral infections (such as HIV), a concurrent illness may cause a transient elevation in viral load. The consultant advised the caller to consider this as a potential factor in this patient’s ongoing HCV viremia.

For further reading:
IDSA recommendations on initial treatment of hepatitis C
Chronic Hepatitis C considerations from the VA
FDA information on sofosbuvir
The Rapid Evolution of Treatment Strategies for Hepatitis C from AJG
Gilead Sovaldi profile

Because CCC VA HepLine consultations are based on information provided by the caller or clinician accessing the online consultation center, without the benefit of a direct evaluation or examination of the patient, consultations are intended to be used as a guide. They do not constitute medical advice and are not to serve as a substitute for medical judgment.

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