Sustained Virologic Response in Naive Chronic Hepatitis C Patients
Sustained Virologic Response in Naive Chronic Hepatitis C Patients
Background: There is a tendency to individualize treatment in chronic hepatitis C patients depending on viral load and rapid clearance of HCV-RNA.
Aim: To evaluate the cost (€, 2006) per sustained virologic response in naïve patients with therapy à la carte compared with standard combination therapy.
Methods: A decision analysis model was used to compare standard therapy with peginterferon alpha and ribavirin for 24 weeks for genotype (G) 2/3, and 48 weeks for G1 and therapy à la carte with the same drugs but different durations: G1 high viral load for 48 weeks, G1 low viral load with rapid virologic response for 24 weeks, and without rapid virologic response for 48 weeks, and G2/3 with rapid virologic response for 12 weeks, and without rapid virologic response for 24 weeks.
Results: Sustained virologic response was similar in both strategies. The cost per successfully treated patient for standard therapy is €17,812 and for therapy à la carte €12,313. Assuming that 13,309 patients with standard therapy and 14,450 patients with therapy à la carte achieve sustained virologic response, therapy à la carte has an overall cost-saving of €59.13 million.
Conclusion: Therapy à la carte is a cost-saving strategy for chronic hepatitis C infection compared to standard therapy, with lower investment requirement per patient to achieve sustained virologic response.
Hepatitis C virus (HCV) infection is a major health problem affecting nearly 170 million people worldwide. The majority, approximately 70%, have detectable HCV-RNA, indicating active viral replication. The combination of peginterferon alpha plus ribavirin has become the standard therapy for chronic HCV. Sustained virologic response (SVR), defined by undetectable HCV-RNA concentrations 6 months following therapy cessation, was achieved in 54-63% of previously untreated patients, depending on HCV genotype, the ribavirin dose administered and the therapy duration. Patients infected with genotype 1 are the most common and the least responsive to therapy and need to be treated for 48 weeks. Recently, several studies have proposed shortening the duration of therapy in patients infected with genotypes 2 and 3 who display a rapid virologic response (RVR), i.e. those who achieve undetectable HCV-RNA (as measured by a very sensitive polymerase chain reaction assay) between 4 and 8 weeks of therapy. In addition, patients infected with genotype 1 who have low baseline viral load and who exhibit a rapid HCV-RNA clearance (undetectable HCV-RNA at week 4) may receive a shorter, 24-week therapy while maintaining a similar SVR to the standard 48-week therapy.
These data have prompted the concept of therapy individualization depending on the patient's baseline characteristics, the presence of predictive factors for therapeutic response and the time-course of HCV-RNA clearance. Treatment individualization enables the duration of peginterferon and ribavirin administration to be shortened in patients who achieve RVR. This is particularly true in patients with low baseline viral load. The consequence is a saving in drug and therapy costs. We evaluated the impact of RVR and shortened therapy duration on the cost per SVR compared with standard combination therapy. The analysis was performed on the potential Spanish population of patients with chronic hepatitis C.
The present study was designed to assess the cost per patients with SVR with therapy à la carte compared to standard combination therapy administered to treatment-naïve HCV patients from the Spanish Health Care perspective.
Summary and Introduction
Summary
Background: There is a tendency to individualize treatment in chronic hepatitis C patients depending on viral load and rapid clearance of HCV-RNA.
Aim: To evaluate the cost (€, 2006) per sustained virologic response in naïve patients with therapy à la carte compared with standard combination therapy.
Methods: A decision analysis model was used to compare standard therapy with peginterferon alpha and ribavirin for 24 weeks for genotype (G) 2/3, and 48 weeks for G1 and therapy à la carte with the same drugs but different durations: G1 high viral load for 48 weeks, G1 low viral load with rapid virologic response for 24 weeks, and without rapid virologic response for 48 weeks, and G2/3 with rapid virologic response for 12 weeks, and without rapid virologic response for 24 weeks.
Results: Sustained virologic response was similar in both strategies. The cost per successfully treated patient for standard therapy is €17,812 and for therapy à la carte €12,313. Assuming that 13,309 patients with standard therapy and 14,450 patients with therapy à la carte achieve sustained virologic response, therapy à la carte has an overall cost-saving of €59.13 million.
Conclusion: Therapy à la carte is a cost-saving strategy for chronic hepatitis C infection compared to standard therapy, with lower investment requirement per patient to achieve sustained virologic response.
Introduction
Hepatitis C virus (HCV) infection is a major health problem affecting nearly 170 million people worldwide. The majority, approximately 70%, have detectable HCV-RNA, indicating active viral replication. The combination of peginterferon alpha plus ribavirin has become the standard therapy for chronic HCV. Sustained virologic response (SVR), defined by undetectable HCV-RNA concentrations 6 months following therapy cessation, was achieved in 54-63% of previously untreated patients, depending on HCV genotype, the ribavirin dose administered and the therapy duration. Patients infected with genotype 1 are the most common and the least responsive to therapy and need to be treated for 48 weeks. Recently, several studies have proposed shortening the duration of therapy in patients infected with genotypes 2 and 3 who display a rapid virologic response (RVR), i.e. those who achieve undetectable HCV-RNA (as measured by a very sensitive polymerase chain reaction assay) between 4 and 8 weeks of therapy. In addition, patients infected with genotype 1 who have low baseline viral load and who exhibit a rapid HCV-RNA clearance (undetectable HCV-RNA at week 4) may receive a shorter, 24-week therapy while maintaining a similar SVR to the standard 48-week therapy.
These data have prompted the concept of therapy individualization depending on the patient's baseline characteristics, the presence of predictive factors for therapeutic response and the time-course of HCV-RNA clearance. Treatment individualization enables the duration of peginterferon and ribavirin administration to be shortened in patients who achieve RVR. This is particularly true in patients with low baseline viral load. The consequence is a saving in drug and therapy costs. We evaluated the impact of RVR and shortened therapy duration on the cost per SVR compared with standard combination therapy. The analysis was performed on the potential Spanish population of patients with chronic hepatitis C.
The present study was designed to assess the cost per patients with SVR with therapy à la carte compared to standard combination therapy administered to treatment-naïve HCV patients from the Spanish Health Care perspective.
