- Jul 2018
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europepmc.org europepmc.org
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On 2017 Sep 21, Stuart RAY commented:
Conclusions revised, here Jakobsen JC, 2017
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On 2017 Jul 05, David Thomas commented:
Readers should exercise considerable caution interpreting this report. The review correctly identifies a sparse literature comparing placebo to treatment. As they observe, "there were no data on hepatitis C-related morbidity and very few data on mortality." However, they mistakenly conclude in the preceding sentence that "DAAs do not seem to have any effects on the risk of hepatitis C-related morbidity or all-cause mortality." If there are no data, how could this evidence-based review make that conclusion? The lack of evidence of an effect is not evidence of a lack of effect.
Even greater clarity on the matter comes from understanding why those data are missing. The paucity of long-term mortality data of persons with HCV randomized to placebo versus treatment is because, as Dr. Ray points out, the medical consensus underscored by AASLD/IDSA, EASL, the US National Academies of Sciences, Engineering, and Medicine and others is that treatment with DAAs is beneficial. There would be ethical challenges to randomizing someone to placebo and observing them for 10-20 years to see if they acquire conditions that we know the virus causes when a treatment that eliminates the infection exists. Of course, not all will develop liver cancer or liver failure, but neither does any other complication always occur for conditions for which treatment has universal support.
Readers should note that the lack of placebo-controlled long-term data is because DAAs are effective not evidence "DAAs do not seem to have any effects".
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On 2017 Jun 28, Stuart RAY commented:
This review acknowledges some limitations of the evidence, but fails to balance the limitations of examining long-term outcomes in short-term trials that used SVR as a well-founded surrogate endpoint; perhaps more importantly, the review falls short in the larger context of the global HCV epidemic and elimination campaigns. That this is the case is illustrated by the response from organizations such as AASLD and IDSA, EASL, and related groups in Australia and Asia. Each of these statements provides considerations for the Cochrane review and its interpretation.
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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- Feb 2018
-
europepmc.org europepmc.org
-
On 2017 Jun 28, Stuart RAY commented:
This review acknowledges some limitations of the evidence, but fails to balance the limitations of examining long-term outcomes in short-term trials that used SVR as a well-founded surrogate endpoint; perhaps more importantly, the review falls short in the larger context of the global HCV epidemic and elimination campaigns. That this is the case is illustrated by the response from organizations such as AASLD and IDSA, EASL, and related groups in Australia and Asia. Each of these statements provides considerations for the Cochrane review and its interpretation.
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY. -
On 2017 Jul 05, David Thomas commented:
Readers should exercise considerable caution interpreting this report. The review correctly identifies a sparse literature comparing placebo to treatment. As they observe, "there were no data on hepatitis C-related morbidity and very few data on mortality." However, they mistakenly conclude in the preceding sentence that "DAAs do not seem to have any effects on the risk of hepatitis C-related morbidity or all-cause mortality." If there are no data, how could this evidence-based review make that conclusion? The lack of evidence of an effect is not evidence of a lack of effect.
Even greater clarity on the matter comes from understanding why those data are missing. The paucity of long-term mortality data of persons with HCV randomized to placebo versus treatment is because, as Dr. Ray points out, the medical consensus underscored by AASLD/IDSA, EASL, the US National Academies of Sciences, Engineering, and Medicine and others is that treatment with DAAs is beneficial. There would be ethical challenges to randomizing someone to placebo and observing them for 10-20 years to see if they acquire conditions that we know the virus causes when a treatment that eliminates the infection exists. Of course, not all will develop liver cancer or liver failure, but neither does any other complication always occur for conditions for which treatment has universal support.
Readers should note that the lack of placebo-controlled long-term data is because DAAs are effective not evidence "DAAs do not seem to have any effects".
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY. -
On 2017 Sep 21, Stuart RAY commented:
Conclusions revised, here Jakobsen JC, 2017
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
-