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Just to be precise, these are UK NIHR HTA reports
FOR NICE, not FROM NICE.
Forgive my pedantry but this is an important distinction, given the interest in the topic internationally.
Best wishes
Neal
Professor Neal Maskrey
Consultant Clinical Adviser, Medicines and Prescribing Centre
National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 07770535128
Visiting Professor of Evidence-informed decision making, Keele University, Staffordshire. ST5 5BG
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Alejandro Piscoya
Sent: 23 July 2014 16:18
To: [log in to unmask]
Subject: Re: Since when did case series become acceptable to prove efficacy?
Quite interesting Valerie. I found a report from NICE too:
Regards,
Alejandro Piscoya, MD, MSc(Ed)
Gastroenterologist, Hospital Nacional Cayetano Heredia, Lima-Perú
Professor, School of Medicine, Universidad Peruana de Ciencias Aplicadas (UPC)
Editorial Board, Revista de Gastroenterología del Perú, Revista Colombiana de Gastroenterología, e-WGN
Core Group, Train the Trainers Committee, World Gastroenterology Organization (WGO)
Member, Academy of Educators, American Gastroenterological Association (AGA)
On Wed, Jul 23, 2014 at 9:51 AM, Valerie King <[log in to unmask]> wrote:
Roy—
That’s our read on it. The “evidence” base really consists of case series. Most comparisons
are dose and duration ranges, rather than true comparators. The FISSION trial, as you note, probably suffered issues with the co-treatments used. And this study was exclusively in pts with genotypes 2 and 3. Roughly 2/3 of HCV infection in the US is due to
genotype 1 and there is no comparative data to guide use of the drug. While the majority of uproar about sofosbuvir has been about price, our concern at CEBP has been about the quality of the evidence. Let’s get that right before we start talking money. The
emperor may be a bit unclothed.
For those interested in our evidence report it is available at the following link:
Sofosbuvir for the Treatment of Hepatitis C
Thanks for championing this issue Roy and all.
Valerie
Valerie J. King, MD, MPH
Professor of Family Medicine, and
Public Health & Preventive Medicine
Director of Research
Center for Evidence-based Policy
Oregon Health & Science University
Mailstop MDYCEBP
Suite 250
3030 SW Moody Ave.
Portland, OR 97201
Voice: 503-494-8694
Fax: 503-494-3807
Twitter: @drvalking
From: Evidence
based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Poses, Roy
Sent: Wednesday, July 23, 2014 07:39
To:
[log in to unmask]
Subject: Re: Since when did case series become acceptable to prove efficacy?
I could only find that one study that compares a sofosbuvir regimen (including ribavirin) with a PEG-interferon plus ribavirin regimen:
Lawitz E, Mangia A, Wyles D et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887. Link
here.
Note that apparently the doses of ribavirin used in the two arms were not the same, and the dose in the PEG-interferon arm may not have been optimal.
I have posted some of my discussion, and links to several EB discussions about the sofobuvir trials here:
http://hcrenewal.blogspot.com/search/label/Sovaldi
I have not seen any other trials that compared sofosbuvir containing regimens to other active regimens. I believe there was one placebo controlled trial.
I still don't see why case-series without any control groups are now regarded as credible ways to evaluate efficacy of therapy???
On Wed, Jul 23, 2014 at 10:19 AM, Alejandro Piscoya <[log in to unmask]> wrote:
The first studies were not so different, both were reported together....
N
Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
Have not been able to find a RCT comparing current practice Pegylated interferon + Ribavirin
against sofosbuvir + rivabirin.
Anyone find those? There are several comments on the price of this new treatments...
Best regards,
Alejandro Piscoya, MD, MSc(Ed)
Gastroenterologist, Hospital Nacional Cayetano Heredia, Lima-Perú
Professor, School of Medicine, Universidad Peruana de Ciencias Aplicadas (UPC)
Editorial Board, Revista de Gastroenterología del Perú, Revista Colombiana de Gastroenterología, e-WGN
Core Group, Train the Trainers Committee, World Gastroenterology Organization (WGO)
Member, Academy of Educators, American Gastroenterological Association (AGA)
On Mon, Jul 21, 2014 at 1:57 PM, Poses, Roy <[log in to unmask]> wrote:
The inadequacies of case series, plus/minus comparisons to historical controls to prove efficacy (or just about anything, in most cases, except when the results were
truly extraordinary, e.g., penicillin curing bacterial pneumonia) was an early lesson of my fellowship, in 1981.
Now it appears that things have changed:
http://www.bloomberg.com/news/2014-07-20/gilead-drug-combination-cures-hepatitis-c-in-hiv-patients.html
Sulkowski MS et al. Sofosbuvir and ribavirin for hepatitis C for patients with HIV coninfection. JAMA 2014; 312: 353. doi:10.1001/jama.2014.7734
Saag MS. Quantum leaps, microeconomics, and the treatment of patients with hepatitis C and HIV coinfection. JAMA 2014; 312: 347. doi:10.1001/jama.2014.7735
Anybody know why?
--
--
Roy M. Poses MD FACP
President
Foundation for Integrity and Responsibility in Medicine (FIRM)
[log in to unmask]
Clinical Associate Professor of Medicine
Alpert Medical School, Brown University
[log in to unmask]
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