None listed
Conditions
Brief summary
We designed this comparative effectiveness study as a quick economic model to timely support making an urgent choice for a cost/effective dual antiviral treatment protocol for chronic hepatitis C in a limited resource charity setting. Methods: Data collected during the period of this interim report from the first 25 patients randomized to either one of two generic Sofosbuvir products (Grateziano or Gratisovir) in a daily dose of one 400 mg tablet plus a weight based ribavirin dose, were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment. Results: As we planned to include a sample of 200 patients for a mean follow up duration of 9 months, the full report is expected to be available by the end of the year 2016. Here we present interim data collected from the first 25 patients included in the study during the first 2 weeks of treatment. The Log10 transformed virus load (Log PCR) in both groups showed an almost equal markedly significant reduction both at the end of week 1 and week 2 of starting treatment by more than 4 and 5 Logs respectively. The differences between the 2 treatment groups at both analysis points were not statistically significant (p = 602, 728) by both student t test and repeated measures ANOVA test.Whereas the difference between proportions of patients with ultra-rapid virologic response (uRVR) at the end of week 1 and very-rapid virologic response (vRVR) at the end of week 2 in both groups were also not statistically significant (vRVR: 10/13 versus 10/12 respectively (p = 0.95, 0.86 respectively)) Conclusion: We can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally effective and equally rapid in reducing the HCV virus load. The predictive accuracy of our suggested markers of efficacy (the vRVR and the uRVR) and the results of truncated 3 months response guided therapy versus the recommended 6 months course duration will be addressed upon full completion of the study in our final report.
Interventions
Group 1 started treatment with Gratisovir 400mg tablets (Sofosbuvir-Pharco), one tablet daily after main meal plus Weight-Based Dosing (WBD) of Hepaverin capsules (Ribavirin) 1200mg if body weight is 75kg or above and 1000 mg if body weight is <75 kg, twice daily, orally; patients who achieve very rapid Virologic response (i.e. undetectable hepatitis C virus RNA Levels at week 2) will be then randomized to receive treatment for a total duration of 3 months or 6 months. Patients who do not ach
Group 1 started treatment with Gratisovir 400mg tablets (Sofosbuvir-Pharco), one tablet daily after main meal plus Weight-Based Dosing (WBD) of Hepaverin capsules (Ribavirin) 1200mg if body weight is 75kg or above and 1000 mg if body weight is <75 kg, twice daily, orally; patients who achieve very rapid Virologic response (i.e. undetectable hepatitis C virus RNA Levels at week 2) will be then randomized to receive treatment for a total duration of 3 months or 6 months. Patients who do not achieve the very rapid virologic response will be treated for a total duration of 6 months.
Sponsors
Mostafa Yakoot
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Chronic Hepatitis C genotype 4 infection with HCV RNA levels > 4 Log 10
Exclusion criteria
Other causes of chronic hepatitis such as hepatitis B or autoimmune hepatitis. critically ill patients and severe organ dysfunctions
Outcome results
None listed