Friday, September 8, 2017

Small case series of 5 patients - Viral load at the end of HCV treatment may not always imply therapeutic failure

Correspondence
The American Journal of Gastroenterology -

Case series of 5 patients with quantifiable viral loads at the end of treatment who subsequently achieved sustained virologic response (SVR)

Owing to the limitations of this small case series of 5 patients, definitive conclusions regarding the clinical usefulness of end-of-treatment viral loads cannot be made. Although further studies are needed to determine the significance of quantifiable viremia at the end of treatment, the results of this case series demonstrate that this phenomenon does not always imply therapeutic failure.

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Detectable Viremia at the End of Treatment With Direct-Acting Antivirals Can Be Associated With Subsequent Clinical Cure in Patients With Chronic Hepatitis C: A Case Series
Lindsey M. Childs-Kean University of Florida College of Pharmacy, Department of Infectious Diseases, Gainesville, Florida Joseph Hong Antimicrobial Stewardship Program, Bay Pines VA Healthcare System, Bay Pines, Florida

DOI: http://dx.doi.org/10.1053/j.gastro.2017.06.062

We report a case series of 5 patients with quantifiable viral loads at the end of treatment who subsequently achieved sustained virologic response (SVR) with recommended hepatitis C virus (HCV) direct-acting antiviral (DAA) regimens.

All 5 patients had HCV genotype 1a, were male, and none were coinfected with human immunodeficiency virus.

Their ages ranged from 56 to 67 years. All patients had a baseline viral load between 2,000,000 and 7,000,000 IU/mL (Table 1).

Three of the patients received 8 weeks of ledipasvir/sofosbuvir (LDV/SOF), one received 12 weeks of LDV/SOF, and one received 12 weeks of paritaprevir/ritonavir/ombitasvir/dasabuvir with ribavirin (PrOD+RBV). One patient who received 8 weeks of LDV/SOF and the patient who received PrOD+RBV were African American. One of the patients who received LDV/SOF had possible cirrhosis based on his elevated Fibrosis-4 scores; none of the other patients who received LDV/SOF seemed to have cirrhosis. The patient who received PrOD+RBV had compensated cirrhosis. All of the patients who received LDV/SOF were treatment naïve; the patient who received PrOD+RBV had previously received pegylated interferon monotherapy. Two patients receiving LDV/SOF received concomitant omeprazole therapy and were advised to take it at the same time as LDV/SOF. All patients reported complete adherence to the DAA regimen and tolerated treatment well. Viral loads were measured using the Abbott M2000 RealTime System (Abbott Laboratories, Lake Bluff, IL), which has a lower limit of quantification of 12 IU/mL, lower than that in published phase III trials.1, 2, 3


Table 1 Virologic Trends During and After HCV Treatment
       
Patients Units Baseline Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 SVR4 SVR12
1IU/mL2,200,2243501817023ND
Log_HCV6.342.542.261.851.36ND
2IU/mL2,557,795496321<12ND
Log_HCV6.411.691.801.33<1.08ND
3IU/mL3,852,0201005113NDND
Log_HCV6.5921.711.12NDND
4IU/mL5,799,6601564486286107<12ND
Log_HCV6.763.192.692.462.03<1.08ND
5IU/mL6467,86930087804412485625<12ND
Log_HCV6.813.482.892.642.391.751.40<1.08ND

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