Sofosbuvir Essay
Critical Review Form
Quantitative Studies
TITLE of your article:
Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients with Unfavorable Treatment Characteristics
STUDY PURPOSE:
Was the purpose stated clearly? ✓ Yes ___ No
Outline the purpose of the study (i.e., study objective or aim):
- This study’s purpose was to assess the safety and effectiveness of sofosbuvir and ribavirin (either weight based or low dose) in patients who are of black race, have advanced liver fibrosis, elevated baseline HCV viral loads, IL28B CT or TT genotypes or previous treatment experience.
LITERATURE:
Was relevant background literature reviewed? ✓ Yes
___ No
Describe the justification of the need for this study (3-4 key points) o The concomitant …show more content…
The first part was a proof of concept: which included 10 patients who were selected based on their mild-moderate liver fibrosis. The patients in the first part of the study were not randomized. They received weight-base dosing of ribavirin. Patients who weighed >75 kg received 1200 mg/day of ribavirin with 400mg of sofosbuvir. Patients who weighed ≤75 kg received 1000 mg/day with 400mg of sofosbuvir.
- The second part of the study consisted of randomization of 50 patients from all stages of liver fibrosis. These patients received 400 mg of sofosbuvir with either weight-based or low dose ribavirin.
- For patients in which the treatment failed, they receive the standard of care.
Can the author answer the study question with the study design?
- Yes, the participant characteristics reflected patients who are underrepresented in previous studies. The proof of concept part of the study is relevant because it establishes the safety of the drug in the target population.
Were the design and/or method used introducing biases. If so describe:
- A potential bias with the study design is the small sample size. This may have an impact of how the results of the study are interpreted, it’s more difficult to find …show more content…
♣ Did not mention if the patients were taking other medications concomitantly when on the trial medications.
What are the implications of these results for your practice?
- It is important to consider the patient’s characteristics when considering HCV therapy.
- Patients who are of black race, advanced liver fibrosis, baseline HCV RNA >800,000, IL28B CT or TT genotypes and previous treatment experience; are more likely to achieve high SVR with SOF/weight-based dosing than with interferon-based therapy.
- Male patients with advanced liver fibrosis and high baseline HCV RNA are more likely to relapse when taking direct-acting antivirals and ribavirin.
- Weight-based RBV is more effective than low-dose RBV in patients with HCV RNA >800,000.
- This was a small study; therefore, the results were not considered significant. Larger studies are warranted for further evaluation of RBV dosing.
Potvin 2007 modified from Law, Stewart, Pollock, Letts, Bosch, & Westmorland,
Quantitative Studies
TITLE of your article:
Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients with Unfavorable Treatment Characteristics
STUDY PURPOSE:
Was the purpose stated clearly? ✓ Yes ___ No
Outline the purpose of the study (i.e., study objective or aim):
- This study’s purpose was to assess the safety and effectiveness of sofosbuvir and ribavirin (either weight based or low dose) in patients who are of black race, have advanced liver fibrosis, elevated baseline HCV viral loads, IL28B CT or TT genotypes or previous treatment experience.
LITERATURE:
Was relevant background literature reviewed? ✓ Yes
___ No
Describe the justification of the need for this study (3-4 key points) o The concomitant …show more content…
The first part was a proof of concept: which included 10 patients who were selected based on their mild-moderate liver fibrosis. The patients in the first part of the study were not randomized. They received weight-base dosing of ribavirin. Patients who weighed >75 kg received 1200 mg/day of ribavirin with 400mg of sofosbuvir. Patients who weighed ≤75 kg received 1000 mg/day with 400mg of sofosbuvir.
- The second part of the study consisted of randomization of 50 patients from all stages of liver fibrosis. These patients received 400 mg of sofosbuvir with either weight-based or low dose ribavirin.
- For patients in which the treatment failed, they receive the standard of care.
Can the author answer the study question with the study design?
- Yes, the participant characteristics reflected patients who are underrepresented in previous studies. The proof of concept part of the study is relevant because it establishes the safety of the drug in the target population.
Were the design and/or method used introducing biases. If so describe:
- A potential bias with the study design is the small sample size. This may have an impact of how the results of the study are interpreted, it’s more difficult to find …show more content…
♣ Did not mention if the patients were taking other medications concomitantly when on the trial medications.
What are the implications of these results for your practice?
- It is important to consider the patient’s characteristics when considering HCV therapy.
- Patients who are of black race, advanced liver fibrosis, baseline HCV RNA >800,000, IL28B CT or TT genotypes and previous treatment experience; are more likely to achieve high SVR with SOF/weight-based dosing than with interferon-based therapy.
- Male patients with advanced liver fibrosis and high baseline HCV RNA are more likely to relapse when taking direct-acting antivirals and ribavirin.
- Weight-based RBV is more effective than low-dose RBV in patients with HCV RNA >800,000.
- This was a small study; therefore, the results were not considered significant. Larger studies are warranted for further evaluation of RBV dosing.
Potvin 2007 modified from Law, Stewart, Pollock, Letts, Bosch, & Westmorland,