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"Medicaid Evidence-Based Decisions Project at OHSU" Report Questions Sofosbuvir Research & the AASLD Guidelines & Medicaid Director (NAMD) Comments
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"The overall methodologic quality of the guidance was poor", the Report says about the Guidelines. And about the sofosbuvir research says "all but one was at high risk of bias". Medicaid (NAMD) National Association of Medicaid Directors is quoted in the article on Medpagetoday as saying "The report is an important step that will help public and private payers make decisions about sofosbuvir".
You can find this report it online at
The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report obtained by the National Association of Medicaid Directors.
According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care.
The only available guidelines for its use -- guidelines created by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America -- are "methodologically flawed," according to the report, which was prepared by the Center for Evidence-Based Policy at Oregon Health and Science University in Portland (OHSU).
In addition, their authors and sponsors had "multiple and significant conflicts of interest," the report argued.
The report was originally prepared for the Medicaid Evidence-Based Decisions Project at OHSU and shared with the Medicaid directors.
A spokesman for the AASLD said the report's authors had mistaken the nature of the joint publication with IDSA.
In fact, Adrian Di Bisceglie, MD, of the St. Louis University School of Medicine, told MedPageToday, "we have been careful to label what we issued as a guidance, not a practice guideline."
The two societies, he said, "felt that given the importance of this emerging data on hepatitis C, the fact that these drugs would out there for physicians, some advice, some consolidation of the information, would be very useful to practitioners [and] to insurance companies."
But the document was not meant to be a formal set of guidelines, he said. But the available published research, the report noted, consists of just 10 studies, reported in seven articles, most of which were noncomparative. No studies compared sofosbuvir in HCV genotype 1 patients with another regimen, the report said, and in particular, none compared the drug with the standard of care.
The studies "do not provide sufficient evidence for the routine use of sofosbuvir-containing regimens," the report said.
It added that response rates appear to be high in the trials -- all but one of which was sponsored by Gilead -- but are likely to be lower in "real world" clinical use.
In its approval process, the FDA also looked at data from three unfinished studies, according to the report, but data from those have yet to be published and could not be reviewed.
The guidelines, the report said, are "of poor methodologic quality and [do] not adhere to international or U.S. standards for guideline development. In particular, they do not give assessments of the quality of individual studies nor the strength of the evidence for recommendations."
The AASLD agrees that those assessments are important, Di Bisceglie said, and form part of the society's formal practice guidelines.
In addition, the authors wrote, there is "substantial risk of conflict of interest" influencing the recommendations. Four of the five guideline panel chairs and 15 of the 21 panel members had financial relationships with Gilead.
In its formal practice guidelines, Di Bisceglie said, the society "strives" to keep the proportion of participants with relevant links to industry below 50%.
The report is an important step that will help public and private payers make decisions about sofosbuvir, NAMD's Salo said. "Having the highest-quality evidence is critical to inform these decisions." - Matt Salo, executive director of NAMD, in Washington.
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