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Chronic hepatitis C genotype 1 virus: who should wait for treatment?

ABSTRACT: Elucidation of the natural history of chronic hepatitis C (CHC) and the identification of risk factors for its progression to advanced liver disease have allowed many physicians to recommend deferral treatment (triple therapy) in favour of waiting for new drug availability for patients who are at low risk of progression to significant liver disease. Newer generation drugs are currently under development, and are expected to feature improved efficacy and safety profiles, as well as less complex and shorter duration delivery regimens, compared to the current standards of care. In addition, patients with cirrhosis and prior null responders have a low rate (around 15%) of achieving sustained virological response (SVR) with triple therapy, and physicians must also consider the decision to wait for new treatments in the future for these patients as well. Naïve patients are the most likely to achieve a close to 100% SVR rate; therefore, it may be advisable to recommend that patients with mild to moderate CHC should wait for the newer therapy options. In contrast, patients with advanced fibrosis and cirrhosis will be those with the greatest need for expedited therapeutic intervention. There remains a need, however, for establishing definitive clinical management guidelines to maximize the benefit of waiting for new drugs and minimize risk of side effects and non-response to the current triple therapy.

SUBMITTER: Tovo CV

PROVIDER: S-EPMC3961974 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Chronic hepatitis C genotype 1 virus: who should wait for treatment?

Tovo Cristiane Valle CV de Mattos Angelo Alves AA de Almeida Paulo Roberto Lerias PR

World journal of gastroenterology 20140301 11

Elucidation of the natural history of chronic hepatitis C (CHC) and the identification of risk factors for its progression to advanced liver disease have allowed many physicians to recommend deferral treatment (triple therapy) in favour of waiting for new drug availability for patients who are at low risk of progression to significant liver disease. Newer generation drugs are currently under development, and are expected to feature improved efficacy and safety profiles, as well as less complex a ...[more]

PMID: 24659878

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Project description:BACKGROUND:The interferon (IFN)-free regimen of sofosbuvir and ribavirin for 24 weeks was recently approved to treat chronic hepatitis C virus (HCV) genotype 1 (GT-1) infection for patients ineligible for IFN. However, sofosbuvir plus ribavirin therapy is associated with relapse in 15% to 30% of patients with HCV GT-1. Neither the mechanism of relapse nor the optimal re-treatment strategy for these patients is defined. OBJECTIVE:To assess the safety and efficacy of sofosbuvir plus ledipasvir in patients with chronic HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy. DESIGN:Phase 2a, open-label study. (ClinicalTrials.gov: NCT01805882). SETTING:Single U.S site. PATIENTS:14 patients with HCV GT-1 that relapsed after treatment with sofosbuvir plus ribavirin for 24 weeks were re-treated with sofosbuvir plus ledipasvir for 12 weeks. MEASUREMENTS:HCV RNA concentration and population sequencing to detect NS5B S282T mutations. RESULTS:All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic response, including 7 with advanced liver disease (Knodell Histology Activity Index score of 3 or 4) and 1 with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Sofosbuvir plus ledipasvir was well-tolerated with few adverse events. Four grade 3 events (elevated serum creatinine in a patient with baseline renal insufficiency, hypercholesterolemia, and hypophosphatemia) occurred. There were no grade 4 events or treatment discontinuations. LIMITATION:Small sample size. CONCLUSION:The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease. Larger studies are needed to confirm these preliminary efficacy results. PRIMARY FUNDING SOURCE:National Institute of Allergy and Infectious Diseases, National Institutes of Health, National Cancer Institute, and Gilead Sciences.

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Chronic hepatitis C genotype 1 virus: who should wait for treatment?

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Chronic hepatitis C genotype 1 virus: who should wait for treatment?

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