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Utility of On-Treatment Viral Loads During Treatment With Direct-Acting Antivirals in Patients Infected With Chronic
Shila Mortazavi1, Lauren M Hynicka1
1Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, MD, USA.
Insights
On-treatment viral load monitoring may not predict hepatitis C virus (HCV) cure in patients receiving direct-acting antiviral (DAA) therapy. High sustained virologic response rates were observed in both HCV-monoinfected and HIV-coinfected individuals.
Area of Science:
- Hepatology
- Infectious Diseases
- Virology
Background:
- Direct-acting antiviral (DAA) agents have transformed hepatitis C virus (HCV) treatment.
- The role of on-treatment HCV viral load (VL) monitoring remains debated, especially in patients coinfected with HIV.
- Limited real-world data exist on the predictive value of on-treatment VL in this population.
Purpose of the Study:
- To assess the utility of on-treatment HCV viral load monitoring in predicting treatment cure.
- To evaluate the effectiveness of DAAs in a real-world cohort, including HIV-coinfected patients.
Main Methods:
- Retrospective, single-center cohort study of 219 patients treated with DAAs for HCV.
- Analysis included patient demographics, HCV genotype, HIV coinfection status, treatment regimens, and on-treatment VL measurements.
- Sustained virologic response (SVR) was the primary outcome measure.
Main Results:
- The study population (average age 56) was predominantly male, African American, and treatment-naive, with 22.4% coinfected with HIV.
- The most common regimen was 12 weeks of ledipasvir/sofosbuvir; on-treatment VLs were often detectable at week 4.
- Overall SVR was high (96.8%), with similar rates in HCV-monoinfected (96.8%) and HCV-HIV-coinfected (95.9%) patients.
Conclusions:
- High SVR rates achieved with DAAs are comparable between HCV-monoinfected and HCV-HIV-coinfected individuals.
- On-treatment viral load monitoring may not be a reliable indicator of treatment failure.
- Monitoring may aid patient engagement, adherence, and ultimately treatment success.
Abstract:
Background: Direct-acting antiviral (DAA) agents have revolutionized the treatment of chronic hepatitis C virus (HCV) infection. Current data regarding the utility of on-treatment HCV viral load (VL) monitoring are conflicting and limited data are available in HIV-coinfected patients. Objective: The objective of the study was to determine whether on-treatment VLs are predictive of HCV cure in a real-world population. Method: A single-center, retrospective cohort study was conducted using patients who received a prescription for DAA therapy for HCV treatment at a large, tertiary ambulatory care clinic. Results: A total of 219 patients were included in the final analysis. The average age was 56 years. Most patients were male (64.4%), African American (73.1%), and insured by Medicaid (61.6%). Most patients were treatment-naive, noncirrhotic, and infected with HCV genotype 1a (73.1%). About 22.4% of patients were coinfected with HIV. The most common regimen was 12 weeks of ledipasvir/sofosbuvir (53.9%). On-treatment VLs were most commonly obtained at treatment week 4 (42.5%), of which 45.2% of patients were detectable. Sustained virologic response (SVR) was achieved in 96.8% of the total population and 95.9% of HIV-coinfected patients. Of the 7 patients who did not achieve SVR, 3 patients had undetectable on-treatment VLs in the first 8 weeks of therapy. Conclusion: Sustained virologic response rates were similar between HCV-monoinfected patients and HCV-HIV-coinfected patients. This research further supports that on-treatment VLs may not be a valuable indicator of treatment failure but may be helpful to engage patients in care and ensure treatment adherence and ultimately cure.
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