Talk:Sofosbuvir/Archive 1

Nucleotide, not nucleoside

is a nucleotide, not nucleoside, analog. See, for example, PMID 24262278, PMID 24209977, and PMID 23607594 (just to name a few). The inclusion of a phosphate moiety is a major feature of sofosbuvir, overcoming the need for monophosphorylation (a rate-limiting step for most nucleoside analogs).

References

-- 69.138.230.170 (talk) 04:16, 19 January 2014 (UTC)

Good catch. Fixed Formerly 98 (talk) 13:40, 19 January 2014 (UTC)

Advertisement flag

This article has been flagged as excessively promotional, apparently due in part to my edits.

The purpose of this entry is to start a dialog regarding this issue. This article was flagged previously and edited to make the tone less positive, prior to my involvement in editing it, so this is the second time the issue has come up. I believe that these concerns about "puffery" and "promotion" may reflect a lack of familiarity with mainstream views of this drug within the gastroenterology community.

I submit that if the drug genuinely is considered a major advance by the gastroenterology community, it is appropriate for this article to refer to it as such. We have dozens of articles in Wikipedia that refer to specific drugs as being of marginal utility or negative risk/benefit ratio. In many cases these descriptions are highly accurate. How is it fine to refer to studies showing that SSRIs have minimal therapeutic benefit in mild to moderate depression and to point out that fluoroquinolones are thought by many to be overused and to be associated with a higher risk of AEs than other antibiotics, but it is "puffery" and "advertising" to point out that another drug is a major advance and considered paradigm shifting?

The following data points show that a significant percentage of the gastroenterology community see this drug exactly as I have described it.

• Sofosbuvir was designated as a "breakthrough" drug by the FDA. Requirements for this designation include "A drug that is intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

• It was also granted accelerated review in the EU: http://online.wsj.com/article/PR-CO-20130521-911088.html This procedure is "reserved for medicinal products of major therapeutic interest" http://www.googledotcom/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCcQFjAA&url=http%3A%2F%2Fwww.ema.europa.eu%2Fdocs%2Fen_GB%2Fdocument_library%2FRegulatory_and_procedural_guideline%2F2009%2F10%2FWC500004136.pdf&ei=Y_DfUsaPMIn5oAS-zYDQDg&usg=AFQjCNH0kSYz-UCZ_EFeQth-1IfLAPyCSQ&sig2=cEIuFdNGSgfJcmpkZ3GVvQ&bvm=bv.59568121,d.cGU&cad=rja

• The EMA set up a "compassionate use" program to make the drug avaialable to patients with late stage disease associated with liver transplant prior to EMA approval. It has only done with with 2 prior drugs in the agency's history. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/10/news_detail_001932.jsp&mid=WC0b01ac058004d5c1

• The FDA briefing document for the Antiviral Drugs Advisory Committee states: "In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population. In the HCV GT 1 and 4 populations, sofosbuvir in combination with pegylated interferon and ribavirin provides increased efficacy and shorter treatment duration compared with currently approved regimens. The shorter 12 week duration translates into a better tolerated side effect profile with observed treatment discontinuations due to AEs of less than 2%."http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371876.pdf

• At least some (the official transcript has not been released) of the AdCom members described the drug as "game-changing". http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews[tt_news]=221257&cHash=da03e20e36.
  • "This is "truly a historic moment," said panelist Dr. Demetre Daskalakis, medical director of the HIV program at Mt. Sinai School of Medicine, New York. "I can’t wait to get this drug into the clinic. We are all excited," he added.
  • The consumer representative on the panel, Daniel Raymond, policy director at the Harm Reduction Coalition, New York City, said that the company had "pulled off the hat trick" of superior efficacy, safety, and convenience over current treatments.
  • "I voted yes because, quite simply, this is a game changer," said Dr. Marc Ghany, staff physician in the liver diseases branch at the National Institute of Diabetes, Digestive and Kidney Diseases, Bethesda, Md."
  • The committee voted 15-0 in favor of approval. I don't have the statistics at hand, but unanimous votes in favor of approval by FDA advisory committees are quite uncommon.

• "Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Dr. Edward Cox, director of the office of antimicrobial products at the F.D.A. " http://www.nytimes.com/2013/12/07/business/fda-approves-pill-to-treat-hepatitis-c.html

• "It is a game changer," said Professor Mark Thursz, a professor of hepatology at Imperial College and consultant in hepatology."We have been following the development of this drug for the past few years, looking at the trial data and getting very excited. For me the excitement is about what it can do for patients. "There are patients we can now treat."" http://www.heraldscotland.com/news/home-news/game-changing-hepatitis-c-treatment-given-green-light.1390057025

I can pull up a few dozen more of these types of quotes if it is helpful. I attended the AASLD and EASL meetings last year and the enthusiasm for this drug is overwhelming. Prescriptions are already at a 1700/week run rate http://www.thestreet.com/story/12253453/1/gileads-sovaldi-hep-c-drug-launch-strong.html which comes to 88,000 per year, and the drug has been available for only a month. By contrast, it is generally believed that fewer than 50,000 HCV patients were treated with all drug regimens combined in 2012.

According to WP:NPOV, "Neutrality assigns weight to viewpoints in proportion to their prominence." I believe the article as currently written does exactly that.

Your thoughts?

Formerly 98 (talk) 11:29, 22 January 2014 (UTC)

Hi Formerly! I wasn't aware that this article has been edited by you, so please don't take the flag personally. My main concern is that IF is repeatedly (three times!) called a drug with severe side effects, while sofosbuvir doesn't seem to have any to judge from the article. Neither has it any contraindications or interactions. This seems rather unbalanced. (Mind you, I haven't got access to the sofosbuvir trials.)

(1) While IF can have severe side effects, it is tolerated well by some patients.

(2) Sofosbuvir is combined with IF unless a patient is IF-intolerant, but the lead sounds as if it were a replacement (which it is in some cases, but not always). This claim is supported by a news releases, but (as far as I can see) not by WP:MEDRS sources.

(3) Could we avoid WP:PEACOCK terms like "dramatically shorter course of therapy" and say that the time is ½ or ¼ that of traditional treatments? Then readers can judge for themselves whether this is dramatic. (WP:Let the facts speak for themselves)

(4) Your quotes are interesting, but also not WP:MEDRS.

Cheers --ἀνυπόδητος (talk) 12:56, 23 January 2014 (UTC)

Hi Anypodetos:

Thanks for your note. I value and appreciate your feedback, though I must admit to intially feeling a little put off that this article was tagged without any specific remarks being left on the Talk page. Thus my vigorous response.

On more careful review, I agree that my language on IFN AEs is probably overstated, though it will depend on the patient group, and the problems are worse when a PI is on board, which in the US is now SOC. In the telaprevir clinical trials, 10% experienced SAEs and another 30% or so likely avoided SAEs through intensive management, including ribavirin dose reduction, transfusions, treatment for rash and teleaprevir treatment discontinuation. In the case of cirrhotics, the CUPIC study found a 40% SAE rate for PEG/IFN/telaprevir and several percent treatment-related death.

The absence of AE reports for sofosbuvir simply reflects that the article is still a work in progress. I'm running through the sections in the pharmacology style guide one at a time as I get to them. The last 2 weeks have been pretty busy here and so I had to put it down for a while.

I agree that your comment about the use of sofosbuvir in combo with PEG/IFN is correct. While the trials included patients who were merely "interferon unwilling", in the US the FDA approval for the interferon-free regimen in genotype 1 is limited to those who are "interferon-intolerant". I missed this. The approval for genotypes 2 and 3 does not include this restriction, but the SVR rates are not that great in GT3 as I noted in the article.

I fully agree that none of the comments I list above is MEDRS. That's part of why they are not incorporated in the article! (Also, I hate the use of quotes by third parties in articles, which is so often used by editors to inject their own opinions in a psuedo-NPOV compliant manner). But in spirit, I think they are "MEDRS-like" and suitable for inclusion in a discussion of the type we are having here. Like a review article, the comments of AdCom members are third party reviews of the research by experts in the field. The main difference is that these experts have not put their thoughts to paper.

I am firmly committed to the use of MEDRS compliant sources in the article, but this again is a function of time which has been in short supply. Such sources are in short supply for a drug for which Phase 3 results were released only in the last 6 months. Most of the available reviews are behind paywalls. Most of those that are availalble I have chosen not to use because while MEDRS compliant, they were written by authors with financial ties to the manufacturer.

I will make some adjustments to the article today per your comments, but others will have to wait until I can get over to the university library (thereby avoiding the paywalls), which will likely be a week or so from now.

Formerly 98 (talk) 14:47, 23 January 2014 (UTC)

Restored January 10 version of lede and Medical Uses sections, thereby removing all contested material. Formerly 98 (talk) 07:54, 24 January 2014 (UTC)

Removed Advert flag. Again, sorry for not being more specific in the beginning. Not sure whether it was necessary to remove all the material on phase 3 trials, but as the drug is now approved and 3rd party sources are available, we probably don't need detailed information about the trials.

Drugs.com has information about interactions, side effects and pregnancy/breast feeding warnings. This source is somewhat package-insert like, but a good starting point / supplement for review articles and the like in my opinion. I was going to add some of this, but I don't want to interfere as you are working on the article. (I might still do some minor things if you don't mind.) Cheers --ἀνυπόδητος (talk) 12:46, 25 January 2014 (UTC)

Please feel free to edit, for now I have no further plans to edit this particular article.

At risk of sounding (being?) petulant, my complete revert of my previous contributions was driven by the desire to get the "advertisement" flag removed as quickly as possible. I feel this was a pretty big gun to bring to bear on what I see as the relatively modest and debatable excesses that were present in this article, especially as it was still a work in progress. Within 24 hours of this tag being placed, I was accused by an admin of being a paid promotional editor, under circumstances such that I believe the placing of this tag played a key role in prompting her suspicions.

Recognizing that you have been very helpful to me and having no doubt that your intentions are the best imaginable, I'm troubled by how quickly and forcefully mistakes made in editing this article were dealt in compared with articles with far greater negative bias (such as the SSRI article and the ciprofloxacin article prior to my edits), which in some cases have a history of being tolerated on Wikipedia for many years. I'm also troubled by quickly this situation spiraled into accusations of bad faith editing, and that all of this happened in spite of my taking the extra step of asking a Wikipedia Medical Project Administrator (Jmh649) to review my work on this article after these edits were entered and before any of these events took place. Respectfully Formerly 98 (talk) 13:58, 25 January 2014 (UTC)

One reason may be that articles on new drugs get more attention than long-standing ones. I think the gyrase inhibitor issues were addressed pretty quickly, but said editor talked everybody down till people simply gave up. Somehow, they never crossed the line of getting blocked. (I think that was at least partly due to the fact that there were no uninvolved MED/PHARM admins left after a very short while...)

Re your concern about there not being a template complementary to {{Advert}}: you can use {{Unbalanced}}. --ἀνυπόδητος (talk) 19:59, 25 January 2014 (UTC)

"One reason may be that articles on new drugs get more attention than long-standing ones." I think this is a fair and reasonable point, but I also think the culture here is such that that threshold for being accused of bad faith editing is much lower for removing negative information relative to positive information, even if both are equally unsupported by mainstream references. There are many examples of insanely negative articles that have been around for years, but I'm not personally aware of any insanely promotional ones.

Anyway, I guess this just circled back to the reason I left Wikipedia last year: there's just certain areas that are not subject to discussion unless one wants to constantly have one's integrity questioned. Perhaps the take home message is that one should not take up residence in a vegetarian commune and then complain about the lack of meat. Best Wishes Formerly 98 (talk) 20:40, 25 January 2014 (UTC)

Could you give me some examples? Maybe I can fix a few things. I'm aware of the SSRI issue but I'm not going to touch that as I'm far from neutral towards these drugs.

By the way, the side effects section I've added turns out to make the article more positive, as the reduction of side effects in IF free treatments is pretty dramatic. any idea what GS-331007 refers to? Is this the monophosphate by any chance? --ἀνυπόδητος (talk) 10:18, 26 January 2014 (UTC)

Yes, yes, this is what I've been trying to say :>). Greatly reduced side effects/shorter treatment duration/ higher cure rates --> "important advance", though not all of these things have been put together in one regimen yet. The combination of sofos and ledapasvir, which will with 95% certainty be approved this year, has shown 94% GT-1 cure rates in an 8 week interferon-free and ribavirin free treatment paradigm. A far cry from curing 50% in 12 months with two poorly tolerated drugs.

In the FISSION study, 11% of patients treated with peginterferon/RBV discontinued due to AEs vs 1% in the sofosbuvir/RBV arm. Hematological AEs included (Sofosbvur/RBV arm and PEG/RBV arm respectively): anemia 8%/12% (mainly due to RBV), decreased lymphocytes 0%/6%, decreased neutrophils 0%/12%, decreased platelets 0%/7%, decreased white cell count 0%/10%. Non-heme AEs included nausea (18%/29%, insomnia 12%/29%, fatigue 36%/55%, headache25%/44%, flu symptoms 3%/18%, chills 3%/18%, rash 9%/18%, diarrhea 9%/17%, myalgia 8%/16%. This comparison is to 24 weeks of PEG/IFN only, when you look at the former SOC for genotype 1 you have a full year of PEG/IFN for many patients and the protease inhibitor has some pretty nasty side effects as well including severe rash which in some cases advanced to Stevens-Johnson.

The U.S. prescribing information for Pegasys has the following warning:

WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS

Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or lifethreatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy

In all hepatitis C studies, one or more serious adverse reactions occurred in 10% of CHC monoinfected subjects and in 19% of CHC/HIV subjects receiving PEGASYS alone or in combination with COPEGUS. The most common serious adverse reactions (3% in CHC and 5% in CHC/HIV) was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other SAEs occurred at a frequency of less than 1% and included: suicide, suicidal ideation, aggression....

Overall 39% of subjects with CHC or CHC/HIV required modification of PEGASYS and/or COPEGUS therapy. The most common reasons for dose modification of PEGASYS in CHC and CHC/HIV subjects was for neutropenia (20% and 27%, respectively) and thrombocytopenia (4% and 6%, respectively).

The difference between interferon based and interferon free treatment is not just the AE rates, but the fact that intensive management is required to keep the AE rates from being even higher in the interferon based regimens.

Recognizing that the work is not published and is therefore clearly non-MEDRS, in ION-1, 94% of prior treatment failures treated with sofosbuvir and ledipasvir for 12 weeks achieved SVR. 20% were cirrhotic, a particularly difficult to treat subgroup. The current standard of care for this group is a year's treatment with PEG/RBV and 12 weeks to one year treatment with a protease inhibitor, leading to about 35-40% SVR. 94% of treatment naive patients were cured in 8 weeks with the same regimen. Anemia was seen in only 0.5% and less than 1% discontinued due to AEs. We've come a long way from curing 35-50% with a year of poorly tolerated drugs.

These results stem directly from the unique properties of sofosbuvir, which is both very potent and has a very high barrier to resistance. Resistance to protease inhibitors, NS5A inhibitors, and non-nucleoside polymerase inhibitors is commonplace and resistance development during therapy is a major cause of therapeutic failure, but no viral isolate resistant to sofosbvir has ever been isolated from any of the several thousand pateints that have been exposed. Sofosbuvir in combination with either a protease inhibitor such as simeprevir or a NS5A inhibitor such as ledipasvir or daclatasvir cures >90% of GT-1 patients, but no two drug combination and few three drug combinations of protease inhibitors, NS5A inihbitors and non-nukes without sofosbuvir will achieve this. Unlike protease inhibitors, NS5A inhibitors, and non-nukes, sofosbuvir is pan-genotypic, and can be used as the anchor of therapetic regimens directed against any viral subtype. Right now there is no clear path forward for an interferon free regimen for genotypes 2,5, or 6 that is not sofosbuvir based.

Sofosbuvir is "an important advance in the treatment of HCV" :>). Its not an advertisement or a promotion, its just how it is. Just as Elvis Presley cannot be accurately described without saying that he was an important influence on popular music.

GS-331007 is the nucleoside. It is pharmacologically irrelevant as sofos is mainly taken up in the liver through first pass metabolism and coverted to the monophosphate by the route I drew out. Some of the sofos escapes the liver and is hydrolyzed in the serum to the nucleoside. Since the nucleoside dose not enter cells well and is only slowly converted to the monophosphate, it contributes little to the antiviral activity. This is one of those cases where the plasma pharmacokinetics are a side show, having little to do with the concentration of active metabolite in the tissue of interest. Formerly 98 (talk) 03:20, 27 January 2014 (UTC)

And that's what I was trying to say: Don't write "this drug is a breakthrough" but "this drug reduced side effects by X% and increased cure rate by Y%". Even with suboptimal sources, this will attract less criticism, and will be far more helpful to the reader.

I intend to get through your information (including the deleted study data) to see what I can add to put this drug in context. May take a while till I get at it, however. --ἀνυπόδητος (talk) 08:18, 27 January 2014 (UTC)

Pricing criticism

Here are some sources that could be used regarding concerns about pricing: PMID 24337268 and Forbes -- Scray (talk) 12:11, 20 February 2014 (UTC)

I think that NPOV requires a balanced presentation of the exorbitant price of sofosbuvir, Gileads's generally good (compared to other companies) track record of cooperation with the Patent Pool and other agencies working to ensure access in developing countries, and the fact that the company is already in discussions with Indian generics companies to provide the drug at a reduced price in developing countries. I moved the criticism by Doctors of the World out of the intro, because I felt it was unbalanced to keep it there unaccompanied by any discussions of Gilead's negotiations with the Indian generics companies, and especially because the language left readers with the impression that Gilead would charge people in developing countries $84,000 dollars for the drug, which the company has explicitly stated it will not do. Since giving a balanced picture would be too lengthy for the intro, I thought moving the whole thing into the Controversy section made the best sense.

I am not personally thrilled with what Gilead is doing here. The cost in the U.S. is too high, and even at a cost "in the high hundreds of dollars", it will be too high in developing countries as well. But Wikipedia is not here to right great wrongs. Although the "exculpatory" information does not outweigh the damning information, it all should be presented side by side, and not with only a single side of the issue presented in the intro. Formerly 98 (talk) 17:55, 2 March 2014 (UTC)

Historical perspective

Not much in the article about history of the development of sofosbuvir. Here's an article that does have a lot of the history.

http://www.ft.com/intl/cms/s/2/542ad524-8b77-11e2-b1a4-00144feabdc0.html Hepatitis C: the cure? By Sam Knight FT Magazine March 15, 2013 5:40 pm

Some decided that they had just witnessed the cure to hepatitis C. On November 21, 15 days after Ed Gane’s presentation, Gilead Sciences, a US pharmaceuticals company, agreed to buy Pharmasset – effectively the PSI-7977 molecule – for $11.1bn. The founder of Pharmasset, an Italian-Egyptian chemist called Raymond Schinazi, who oversaw the drug’s development, made $440m personally from the sale.

--Nbauman (talk) 09:58, 22 March 2014 (UTC)

candidate MEDRS?

In response to remarks above about the difficulty in identifying MEDRS for a new drug like this, I think the TRIP database could be helpful here for retrieving some candidate sources (including pertinent health technology assessments [1] [2] [3]). Regards, 86.141.190.114 (talk) 11:52, 23 April 2014 (UTC)

POV problem

The "Pricing controversy" section details mainly one side of the controversy, making it unbalanced. There are plenty of experts and editorial writers who say that despite the high price, it is still a good value (see, for example, http://www.vox.com/2014/7/16/5902271/hepatitis-c-drug-sovaldi-price ). Wikipedia should also report a statement from Gilead explaining or defending their pricing. — Preceding unsigned comment added by 71.185.49.96 (talk) 19:11, 3 September 2014 (UTC)

Here's a WP:MEDRS defending the pricing. There are also a couple of letters in response. They assume that the cost of developing sofosbuvir was $11 billion. I would prefer to rename the section, "Cost."

AU - Brennan T

AU - Shrank W

TI - New expensive treatments for hepatitis c infection

TA - JAMA

pages = {593-594},

VI - 312

IP - 6

AID - 10.1001/jama.2014.8897 [doi]

4100 - http://dx.doi.org/10.1001/jama.2014.8897

SO - JAMA August 13, 2014 312(6):593

--Nbauman (talk) 04:46, 26 November 2014 (UTC)

I removed the flag given lack of active discussion of the issue. See the template instructions: "The purpose of this group of templates is to attract editors with different viewpoints to edit articles that need additional insight. This template should not be used as a badge of shame. Do not use this template to "warn" readers about the article."

I also removed the WP:FRINGE statement calling sofosbuvir a "low value" treatment. This is far, far from medical consensus, given that the AASLD revised its treatment guidelines so that all first line and most second line treatment regimens incorporate sofosbuvir immediately upon its approval. It was designated a "breakthrough therapy" by the FDA as well. If anyone has an issue with this removal, I am happy to counterpoint this statement with dozens of references calling sofosbuvir a "medical breakthrough". Formerly 98 (talk) 15:59, 26 November 2014 (UTC)

"Obvious similarity" to tenofovir alafenamide external link

Hi @Vaccinationist:

First, I'd like to apologize for my dismissive edit summary. But I think this edit is inappropriate for several reasons.

• The side chain of Tenofovir alafenamide is similar to that of sofosbuvir. We agree on that.

• But the core is similar to that of acyclovir. And the core of sofos looks much more like the core of zidovudine than that of tenofovir. How many comparisons of this type are we going to make? What value will this bring to our readers (who are mostly non-chemists)?

• Your sources (one of which is a blog) support the statement that both drugs use similar prodrug technology, but not the broader claim that the two molecules have "obvious similarity".

• In the context of the article, the addition appears to chime in with WP:OS supporting the Doctor's of the World allegation that there was no inventive step in the creation of sofosbuvir. This is inappropriate because 1) it is an original synthesis (neither of your sources make that suggestion), and 2) because the effectiveness of TAF was not demonstrated prior to the development of sofosbuvir. The two drugs were developed mostly in parallel, with sofosbuvir entering Phase 3 in 2011 and TAF in 2012. Sofos is a marketed drug, and TAF remains in Phase 3 pre-approval trials.

• I have modified your added text with some proposed compromise language. Overall, I don't think we want to make these sorts of comparisons at all, but I can live with language that avoids implying that sofos is intellectually derivative of TAF in the absence of appropriate sources. Let me know what you think.

73.162.132.47 (talk) 15:26, 24 November 2015 (UTC)

Rationing

In the UK, and presumably elsewhere, the question of the way rationing happens, and the effects, are politically important and need expanding.Rathfelder (talk) 07:02, 15 May 2016 (UTC)

Apparent contradiction

The lead sentence that states the costs in two countries as being "$300 and $5900 respectively for a 12-week treatment, with each government covering 99% and 70% of the cost respectively" contains the apparent contradiction of differing base cost between the two. The contradiction should be removed or explained. Removal is simple, with the revision to "each government covering large percentages of its patient's costs". Le Prof 14:49, 13 September 2016 (UTC) — Preceding unsigned comment added by 73.211.138.148 (talk)

Please offer your opinion of including or not including this content

I support adding this content to the section where the drug's $84,000 price is criticized:

However, this is far cheaper than expensive hospitalizations and liver transplants, which cost an average of $577,000.

What do other editors think of including or not including this content?

References

71.182.236.149 (talk) 05:46, 15 October 2016 (UTC)

Iranian drug

so, this edit.... there is still no source for the price and the % reimbursement. That spreadsheet was interesting to look over. Oh, correction! the price of this drug is there. and bizarrely, out of ~3,000 entries in this speadsheet, there are only prices for this drug and for Dimethyl Fumarate. This doesn't seem... ok. Jytdog (talk) 08:00, 8 November 2016 (UTC)

Now you know a lot about the drugs available in Iran :-) The price feild on the excel file is not being well maintained as the FDA is not the organization which determines the final price. The reference for price and the percent covered by insurance is on the social security web site https://darman.tamin.ir/Forms/Public/Druglist.aspx?pagename=hdpDrugList. The prices are obviously in Iranian Rls and the web site is in Persian. But you can understand the numbers and percents. The direct web links to a search page on the FDA site to see if a drug is approved or not and on what date would be http://www.fda.gov.ir/item/463. Search for sofosbuvir. When you click on the name you will get approval dates/etc but not the price (on this web site). Unfortunately these are all in Persian and no reliable working English version is online (yet). Someone knowing Persian will be able to navigate her way arround these web sites and will be able to confirm all this. How do you suggest I fix these links? Would it be ok to give the links to the search pages (as above)? Thanks for helping me out. — Preceding unsigned comment added by Merats (talk • contribs) 08:55, 8 November 2016 (UTC)

Class project

05:47, 15 November 2016 (UTC)

Wiki Education Foundation-supported course assignment

This article is or was the subject of a Wiki Education Foundation-supported course assignment. Further details are available on the course page. Student editor(s): Kevin.tran, JMa133, Hnublis, NouL, Rpark0211. Peer reviewers: Catloucsf, Katherine.Kazanjian, Amandannhi, AndrewPhamUCSF, Amandannhit.

Above undated message substituted from Template:Dashboard.wikiedu.org assignment by PrimeBOT (talk) 03:42, 18 January 2022 (UTC)

Group 25 Edit Plan

We plan to edit 1. Lead-in 2. Medical Uses 3. Adverse Effects 4. Interactions. We also will add a section on contraindications and pharmacokinetics. In order to add/edit information we would use reputable scholarly sources such as Lexicomp, Micromedex Embase, DailyMed, and Pubmed. These sources will allow us to compare and contrast information and provide the best updates to the current page. Rpark0211 (talk) 04:14, 3 November 2016 (UTC) (redacted — Preceding unsigned comment added by Rpark0211 (talk • contribs) 4 November 2016 (UTC))

Please review WP:MEDRS; we need fairly recent literature reviews in good journals or statements from major medical/scientific bodies for any WP:Biomedical information you want to add. Please also be aware that the "lead-in" is just a summary of the body of the article, per WP:LEAD. Please also review WP:MEDMOS, and please be mindful of WP:WEIGHT in the article overall. Thanks! Jytdog (talk) 04:42, 3 November 2016 (UTC)

Group 26 Review of Group 25 Edits

Student 1: Does the draft submission reflect a neutral point of view? If not, specify...

• Yes. Overall, group 25 did an excellent job at maintaining neutrality. There were no opinions stated as facts and no judgemental language or loaded words were utilized. When asserting sofosbuvir was a better option than other drugs, a source was always utilized to back up the claim. Katherine.Kazanjian (talk) 17:35, 14 November 2016 (UTC)
  

Student 2: Are the points included verifiable with cited secondary sources that are freely accessible? If not, specify...

• Yes. Group 25 did an excellent job in citing various sources for their points. Their citations were diverse, including package insert, journal reviews, FDA announcements, IDSA guidelines, and popular webpages. They included the pdf documents, as well as the web link, for easy reader acess. Catloucsf (talk) 22:49, 14 November 2016 (UTC)Catherine Lo

Student 3: Are the edits formatted with Wikipedia's manual of style for medicine-related articles? If not, specify...

• Yes, Group 25's edits follow Wikipedia's manual of style for medicine-related articles. Overall, they use a minimal amount of medical jargon and utilize layman terms. Also, I did not see any use of the words "patients" and "you" in inappropriate areas. AndrewPhamUCSF (talk) 21:17, 15 November 2016 (UTC)

Student 4: Is there any evidence of plagiarism or copyright violation? If yes, specify...

• No, it does not seem that the page is plagiarized or has copyright violation. I randomly chose references and lines from the wikipedia page to compare the sentence details and structure, and it does not seem that any plagiarism is present. Amandannhit (talk) 19:07, 15 November 2016 (UTC)

Katherine.Kazanjian (talk) 17:35, 14 November 2016 (UTC)

This talk page is not a university website. Do not abuse this page to do your homework. Do it somewhere else please. Jytdog (talk) 20:40, 14 November 2016 (UTC)

Ah this is not different in kind from either a GA or FA review (though less in depth). We also have a WP:Peer review process which is similar.

I think the solution to keep talk pages from getting out of hand is simply to place auto archiving and remove class templates once the class is finished. Doc James (talk · contribs · email) 05:44, 15 November 2016 (UTC)

Structure

User:NouL about this, please read and follow the sectioning described in WP:MEDMOS. We usually include pregnancy in Medical use. Jytdog (talk) 01:23, 17 November 2016 (UTC)

Read WP:MEDMOS and only found pregnancy mentioned under "Anatomy" and "Special Populations". Will continue to edit this section for grammar and syntax. JMa133 (talk) 03:25, 17 November 2016 (UTC)

yes if there is not an extensive discussion of Special populations we just include it in Medical use. Jytdog (talk) 03:30, 17 November 2016 (UTC)

Senate hearings

The transcripts of the December 2015 Senate hearings are now online, with a press release and executive summary that summarizes their conclusions. This should at least go in the External Links section, as soon as I figure out the citation format.

https://www.finance.senate.gov/ranking-members-news/wyden-grassley-sovaldi-investigation-finds-revenue-driven-pricing-strategy-behind-84-000-hepatitis-drug
Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug

https://www.finance.senate.gov/download/the-price-of-sovaldi-and-its-impact-on-the-us-health-care-system-full-report
The Price of Sovaldi and Its Impact on the U.S. Health Care System
114th Congress
S. Prt. 114-20
Committee on Finance
United States Senate
December 2015
97-329-PDF

I heard a panel discussion in which one of the panelists said that there was one Powerpoint slide which explained what goes on in a pharmaceutical company executive's head when they decide how to set the price. It's on p. 2 of this pdf https://www.finance.senate.gov/download/the-pricing-of-sovaldi-section-3 with the title, "Aside from payer access and physician demands, there are a number of softer issues that could affect Gilead's final pricing decision." Since this committee report is in the public domain, this slide should also be in the public domain. --Nbauman (talk) 05:04, 17 February 2017 (UTC)