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Clinical effects of simvastatin in chronic hepatitis C patients receiving sofosbuvir/daclatasvir combination. A
Hossam Z Mohamed1, Nagwa A Sabri2, Hossam M Zaki1
1Hepatology Department, Kobri El koba Armed Forces Hospital, Cairo, Egypt.
Insights
Simvastatin may improve treatment success for chronic hepatitis C (CHC) patients using direct-acting antivirals (DAAs). Adding simvastatin to sofosbuvir/daclatasvir showed a trend towards reduced treatment failure, highlighting statins
Area of Science:
- Hepatology and Viral Gastroenterology
- Pharmacology and Drug Development
Background:
- Chronic hepatitis C (CHC) impacts over 71 million globally, with direct-acting antivirals (DAAs) as primary therapy.
- Lipid profile alterations are a key consideration in DAA treatment outcomes.
- Understanding adjunct therapies like statins is crucial for optimizing CHC management.
Purpose of the Study:
- To evaluate the clinical impact of statins as an adjunct therapy in CHC patients.
- To assess the effect of simvastatin on sustained virological response (SVR12) and lipid profiles in CHC patients receiving sofosbuvir/daclatasvir (SOF/DAC).
Main Methods:
- A randomized controlled trial involving 100 treatment-naïve CHC patients.
- Intervention group received simvastatin 10 mg plus SOF/DAC daily for 12 weeks.
- Control group received placebo plus SOF/DAC daily for 12 weeks; SVR12, lipid profile, CRP, and fibrosis were assessed.
Main Results:
- No significant side effects were reported in either group.
- The simvastatin group showed a trend towards lower SVR failure rate (2%) compared to placebo (10%), though not statistically significant (p > 0.05).
- Logistic regression identified high baseline CRP, low baseline hemoglobin, and non-statin use as independent predictors of SVR failure (p < 0.05).
Conclusions:
- Simvastatin may play a beneficial role in enhancing the efficacy of SOF/DAC treatment for CHC.
- Statins could be an important component for successful CHC treatment outcomes when used with DAAs.
Aim Of The Study:
Chronic hepatitis C (CHC) affects more than 71 million people worldwide. Many therapies containing different direct-acting antivirals (DAAs) are now used. However, lipid profile is considered an important outcome with DAAs. So, this study aimed to assess clinical effects of statins in CHC patients.
Material And Methods:
One hundred patients were recruited from Kobri El koba Armed Forces Hospital and randomly assigned to: the drug group (D;n = 50) receiving simvastatin 10 mg plus sofosbuvir 400 mg/daclatasvir 60 mg (SOF/DAC) daily for 12 weeks; and the placebo group (P; n = 50), receiving placebo plus the same (SOF/DAC) regimen. Sustained virological response at 12 weeks after treatment (SVR12), lipid profile, C-reactive protein (CRP) and fibrosis stage were assessed.
Results:
One hundred treatment-naïve CHC patients completed 12 weeks of the protocol with no clinically significant side effects. There was an increase in SVR failure rate in P (10%) compared to D (only 2%) but not reaching statistical significant difference; SVR12 (p > 0.05). Logistic regression analysis showed that high baseline CRP, low baseline hemoglobin level and non-statin usage had an independent effect on increasing the probability of SVR failure in both groups; p = 0.03, p = 0.0028, p = 0.02, respectively.
Conclusions:
Statins could have an irreplaceable role in successful treatment of CHC patients receiving sofosbuvir/daclatasvir.
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