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October 30, 2014

Acting Up Against Ebola


by John S. James

As AIDS activists begin to engage with the ebola outbreak, we need to get our message right. I think we should target dumb quarantines, not all quarantines. Especially, we should target dumb quarantines motivated by politics.

For example, Kaci Hickox, the MSF nurse who was quarantined at Newark Airport and then in Maine, seems to have been selected for quarantine attention because she had a temperature measured once as 101. But later, her temperature measurement became normal and stayed normal. Unless ebola has a quiescent phase -- most unlikely -- that meant that the original measurement was not due to ebola. It should then have been irrelevant to her status. But Maine's governor has a difficult re-election race next week.

If there are more U.S. cases, the cost of a policy of quarantining everybody who cares for an ebola patient also needs to be considered. It would mean that doctors and nurses would be in permanent quarantine until they stopped caring for those patients. All sorts of problems would result.

So far, the most horrible example of dumb quarantine is Louisiana telling medical people who have recently been fighting ebola in West Africa not to attend the meeting of the American Society of Tropical Medicine and Hygiene, November 2-6 in New Orleans. This meeting is supposed to be a forum for sharing experiences and improving strategies for fighting the disease. See http://www.nature.com/news/ebola-controls-at-us-medical-meeting-spark-protest-1.16256

I can't imagine any situation where it would make sense to quarantine people who have no symptoms, no fever, no detectable virus, and no other sign of ebola infection, and who are willing to follow CDC and other medical recommendations. But conceivably, that might change.

Ebola activism is not a direct continuation of AIDS activism. The situations are very different. For example, stigma is a major problem in both cases, but the stigma is different.

Keeping an open mind even on quarantine will help reassure the public that we are always putting their interests first.

April 3, 2014

Follow AIDS Treatment News on Twitter

Visit http://twitter.com/cure4.

We are not updating this blog page temporarily -- to focus on other projects including MDR tuberculosis, and hepatitis C.  Note our Twitter feed at the link above.

March 5, 2013

Retroviruses Conference (CROI), March 2013 in Atlanta

We are at the conference, focusing mainly on HIV/AIDS CURE-related news, and will be posting here.

Our CURE4 Twitter feed (right-hand column on this page), and many of our blog posts, should have more news after March 6. This is because we want to link to abstracts (and sometimes videos or posters) of conference presentations online -- and these are not available to the public until the end of the session in which the presentation occurs. Until then the links only work in the conference center in Atlanta.

Excellent conference news coverage is available at sites including:
 http://www.aidsmap.com/
 http://www.aidsmeds.com/
 http://hivandhepatitis.com/
 http://www.thebodypro.com/index/newsroom/2013-03.html
 http://www.ifarablog.org/ (video, coming soon)
 http://natap.org/ (often more technical)
 http://www.positivelyaware.com/
 http://www.projectinform.org/


December 9, 2012

Robin Hood says No Cuts to AIDS Programs, Tax Wall Street!


December 9, 2012: International Human Rights Day is tomorrow, Monday December 10th. In honor of that day, and with congress considering devastating cuts that would harm the basic rights of millions of people across the world, actions are being scheduled at congressional offices around the country. Robin Hood will be at many of these actions, joining others in the demand of "no cuts", and calling on congress to tax Wall Street.
People living with AIDS cannot afford budget cuts to lifesaving programs, both in the United States and across the world. A Robin Hood Tax on Wall Street could prevent budget cuts to important programs like the Global Fund, the President's Emergency Plan for AIDS Relief, HOPWA, Ryan White Care Programs, and others.
Check out the list of actions below, and come out to support Robin Hood!

July 12, 2012

AIDS2012 Conference, July 22-27 -- Washington DC or Anywhere

By John S. James

AIDS2012, the XIX International AIDS Conference, happens this month, July 22-27, 2012, at the Washington Convention Center in Washington, DC. More than 20,000 people are expected to attend. AIDS2012, organized by the International AIDS Society (iasociety.org) and many others, is the largest AIDS gathering in the world. It takes place in different countries, every two years.

Below are some online information sources that can help you follow the conference news, whether you are at the meeting or not.

[Note: in case you happen to be in the Washington area but not attending the conference officially, one part of the conference, the Global Village, is free and open to the public this year. About 250 AIDS-related organizations from around the world will be presenting there, so you can probably find people you want to meet. While there are likely to be scheduled presentations within the global village, it is mainly a place for informal discussions. (See below for how to participate in these and other discussions even if you are far from Washington.)]

All the sites in this article are publicly accessible (although parts of the official site can only be visited by persons attending the conference, who log in with their conference credentials).

Of the hundreds of sites that will report news from the conference and would be worth listing here, we picked just a handful that are most important for our readers to know about.

Official Conference Site: www.aids2012.org

When looking at all the dozens of items and links available on the home page, don't overlook the navigation bar at the top, with links to the official conference blog, and to the Global Village (plus the youth program, and the media center).

The U.S. government's AIDS blog, blog.aids.gov/, has an entry listing the official partners of the IAS for this conference. For the full list, see http://blog.aids.gov/2012/06/how-to-stay-updated-during-aids-2012.html. Some of the partner organizations:
 * The Kaiser Family Foundation will provide official coverage of the conference, including video of some of the major sessions, and daily news reports. For more information see www.kff.org/hivaids/hiv062712nr.cfm.
 * For basic science news reporting, Science magazine (sciencemag.org) is a good place to start, especially Jon Cohen's articles on AIDS.
[But like too many science and medicine journals, some of the articles are for sale for prohibitive individual prices (at profit margins we estimate at 100,000% or greater, compared to the cost of online delivery -- note that the journals seldom pay for any of the research being reported). To see the full text, you need to be rich or be part of an institution such as a university. Usually anyone can see at least an abstract or summary of research article, and sometimes the full text is made free as well. And some some material is free, but only to registered users (registration is free).]
 * The same is true for the Lancet, a medical journal that is also one of the official partners. The Lancet published a number of AIDS articles shortly in advance of the conference, at www.thelancet.com/journals/lancet/issue/vol379no9835/PIIS0140-6736%2812%29X6026-4. Publishing in advance is helpful, since interested persons can read the new information ahead of time and use it to inform many discussions at the meeting.
 * POZ/Aidsmeds (http://poz.com/), and Aidsmap (www.aidsmap.com/), are two other conference partners with excellent news coverage on AIDS, written for persons with AIDS and the interested public. Check their conference coverage before, during, and after AIDS2012.
 * For religious information, check the Interfaith pre-conference meeting, blog.aids2012.org/post/Interfaith-pre-conference-%E2%80%9CTaking-Action-for-Health-Dignity-and-Justice%E2%80%9D.aspx  (This page was hard to find from the main aids2012.org page, which may explain why there were no comments as of early July.)

Satellite Sessions

For officially recognized satellite sessions (both non-commercial, and commercial) see:
aids2012.org/WebContent/File/AIDS2012_Satellites_List.pdf
Sometimes the public can go to these; sometimes a conference badge is required.

Non-Official Sites (not officially connected with the conference)

Of hundreds of news and other sites, we note three:
 AIDS2012 Reunion, www.aids2012reunion.org/  A new organization, focused entirely on this conference for now.
 Project Inform, www.projectinform.org/. One of the first AIDS treatment information organizations, still doing excellent AIDS treatment news coverage.
 NATAP (National AIDS Treatment Advocacy Project), www.natap.org/, especially for important technical/scientific information.

For more conference coverage, you can do a Google search such as:
"aids conference" 2012
This search finds about 2,000,000 pages on this and other conferences -- fortunately listed by Web popularity. The official aids2012.org pages are organized at the top of the search results, quickly followed many non-official websites and page -- so you don't need to scroll through hundreds of official pages first.

Using Twitter to Find Conference Coverage

You don't need a Twitter account. Just go to search.twitter.com and search for whatever interests you. Twitter shows what's going on now, not going far back into the past. Note: Twitter's search will probably show you the "Top" tweets, but let you choose "All" -- which you probably do want to choose. Also note that Google no longer works for finding tweets; Twitter unfortunately revoked Google's access a year ago, to improve its own search instead.

You can search for #aids2012 (best to include the hash mark). This "hash tag" was suggested by the conference, to use in the text of tweets (Twitter messages) in order to bring them to the attention of people searching for information about the conference. But anyone with a Twitter account can use this hash tag in their tweets -- so be aware that spam or misinformation could also be sent this way.

The Global Village is tweeting officially from @gvaids2012 (no one else can send FROM that Twitter address). We haven't seen anyone using the similar hash tag #gvaids2012 as of early July (note the hash mark punctuation instead of the at-sign), but we recommend it and think people will be using it during the conference and a little before. Anyone with a Twitter account can send a tweet from their phone or computer with this hash tag in it, immediately and without waiting for anyone's approval -- a good way to share news instantly within or about the Global Village (as well as with the rest of the world). And if the people running the official @gvaids2012 account like some of these messages, they can re-tweet them to all followers of @gvaids2012 (whether or not those followers ever search for the hash tag). So using a name in this way (with the'@' from the owner of the Twitter account exclusively, and the '#' for the hash tag that anyone can use) gives both an official and an unofficial channel on the subject (the Global Village of AIDS2012, in this case).

Note that anyone in the world can discuss the AIDS2012 conference on Twitter -- no need to be in Washington. (Well, not anyone; some countries ban Twitter.) You do not need a Twitter account nor any prior knowledge to search recent tweets at search.twitter.com, e.g. for #aids2012, or for the Global Village. You do need a Twitter account to send your own tweets, and also to follow others' Twitter accounts (meaning  to receive all the tweets they send).

Each tweet can only have 140 characters -- basically a short sentence. But about a dozen of the 140 can optionally be used for a Web link, so the tweet can tell you about something quickly, and let you click for more information if you want. As of July 11, 2012,m a new tweet is being sent about every two minutes during the workday Washington time, usually pointing you to more information on the Web, and also at the conference.

A major advantage of Twitter is that you can look things up by searching (either for a hash tag, or just for a word in the tweet), and then connect with people who share a mutual interest, whom you might never otherwise have met.

Conferences of the Future

The bottom line is that you can virtually attend AIDS2012, and have input, even if you are thousands of miles from Washington. We believe that conferences will and should continue to evolve in this direction. Eventually the lectures presenting scientific, medical, and other information will be largely online, with important results released any time they are ready, not held up for arbitrary conference or publication dates. Online (or DVD) presentations are better educationally than lectures in auditoriums, since everyone can see the slides and hear the speakers, can rewind if necessary, and can consult outside materials easily. Why should scientific and medical research reports be tied to the great expense of air travel, hotels, and conference admission?

Future physical meetings will be for persons who need to meet face-to-face with particular working groups and individuals. Based on past experience of online communication actually increasing physical meetings, these better-focused conferences could be even larger than the ones today. For those who can travel abroad it will be better to make one international trip to take care of most of one's global meeting needs, than to make separate trips. And for those who cannot travel, online and DVD information will be much better than it is today -- and more important than the physical meetings that are hundreds of times more expensive.

Researching HIV in WikiLeaks Cables

By John S. James


All 251,287 WikiLeaks "Cablegate" cables have now been released (apparently by opponents of Assange). They are searchable, and 'HIV' is mentioned in 1534 of them. While 107 cables are tagged 'HIV', many other relevant cables are not.

Several specialized search engines will search this huge archive for whatever you want. We used www.CableDrum.net for this article. (Apparently the full text of the cables is indexed in Google, though not in Bing.)

To try CableDrum yourself, visit the site and type HIV into the "Search text" box, then click the Search button. A search might take half a minute or so, but then you should see the Subject of the first 25 of the 1534 cables containing 'HIV'. To read the full text of the cable, click the "Reference ID" on the left of the Subject line.

For this article we decided to look at two issues:
  • What was the U.S. reaction as it became clear that Australia was doing much better than the U.S. in AIDS prevention -- apparently due mainly to very different policies on needle exchange?
  • How did the U.S. embassies see PEPFAR (President's Emergency Fund for AIDS Relief), the outstandingly successful U.S. program to make AIDS treatment available on a large scale to poor countries that otherwise had very little access?
Our research is incomplete, and presented mainly to show you how to use the cable database.

Australia and Needle Exchange

"[Needle exchange programs] have played a vital role in helping prevent the spread of blood-borne illnesses in Australia, according to Paul Dessaur of WASUA. 'In Australia, for instance, the rate of HIV amongst injecting drug users is less than 1 percent, and that is unheard of, and it's purely because we introduced these programs way back in 1986,' he said." [2012, www.cdcnpin.org/scripts/display/NewsDisplay.asp?NewsNbr=59528]

We don't have a comparable U.S. figure for the infection rate among IDUs, but it is probably well over 10 times higher.

Our search for HIV and Australia as tags found nothing. A search for:
HIV Australia
in the full text found 79 cables. Most of them were unrelated, so we tried:
Australia hiv "syringe exchange"
with no result. But:
Australia hiv "needle exchange"
found one result, www.cabledrum.net/cables/09MOSCOW3072, which is relevant (one of only two we've found so far). It described Russia's chief medical officer as "positive about needle exchange
programs, saying that they were proving effective."

Searching for
Australia "needle exchange"
(no need to mention HIV) found 7 results, including the above, plus another relevant cable (www.cabledrum.net/cables/09UNVIEVIENNA64), also dated 2009, referred to the "new USG [United States Government] position: support for needle exchange programs as a method to prevent the spread of HIV/AIDS, and for medication-assisted therapy as part of a comprehensive treatment protocol against narcotic addiction, and continued USG opposition to the term 'harm reduction'." 

What we have not yet done is to read through all the cables mentioning just "needle exchange", "syringe exchange", or with a tag HIV (about 150 cables in all), to find anything that may be relevant.

But already it seems fairly clear already that there is no acknowledgement or discussion of Australia's success with needle exchange anywhere in the text of the 251,287 cables obtained by WikiLeaks. Any such cable would almost certainly include the word 'Australia', and either 'needle exchange' or 'syringe exchange', and we checked all of those cables.

PEPFAR Success

Our work on this search is less complete. Much more remains to be done.

There is no tag for 'PEPFAR' (which seems odd), but the word appears in 587 of the cables. The next step might be to read all places where 'PEPFAR' appears in these cables, to see what is interesting. This would exclude the cable about checking whether the 20 telephones in a new PEPFAR office were working correctly -- and those with only general statement of good intentions, such as:
"USG-Nigeria PEPFAR team submitted the 2010 annual Country Operation Plan (COP) to the Global AIDS Coordinator January 29. The plan builds a partnership for sustainability with the Nigerian Government to continue strengthening ongoing service delivery to patients; renew focus on health systems strengthening; and align activities with the Nigerian National Strategic Framework for HIV-AIDS, 2010-2015. The Plan will also intensify and focus prevention efforts; deepen integration of HIV-AIDS response into the broader health care system; strengthen the health care system at all levels; and expand access to quality services. USAID's proposed FY2010 PEPFAR budget is 249.9 million dollars."

The Surprise

What most surprised us is the lack of perspective in the diplomatic world -- how little attention and actual thinking concern HIV, an epidemic that has killed tens of millions of people including half a million in the U.S. Vastly more attention goes into the drug war -- a shooting war which, in its current form, started a century ago in the U.S., and has been a continuous failure ever since. It still has no victory in sight, only more of the same. The basic flaw may be the same as in other U.S. shooting wars -- the lack of any sane or real mission, since the actual purpose of the war is to create financial opportunities for corporations, contractors, careerists, and other well-placed special interests.

A fundamental problem is that perspective and thinking are dangerous in diplomatic (and other government or corporate) careers; those who think may not last. In theory the thinking will be done at higher levels, but the system is too corrupt for that. So major institutions proceed like zombies, decade after decade and century after century, with results that we see every day.

April 27, 2012

Truvada PrEP, Gilead, AHF's Bizarre Attack: Our statement to the FDA


Submitted to the FDA today, April 27, 2012, by John S. James, AIDS Treatment News:

I strongly support approval of Truvada for PrEP. In the large iPrEx study of men who have sex with men, "No one in iPrEx acquired HIV infection with a drug level that would have been expected with daily dosing" (Dr. Robert Grant, PI, CROI 2011, http://bit.ly/grjVUg). I reported the details exactly a year ago, at http://aidsnews.blogspot.com/2011/04/hiv-prep-explained-critical-prevention.html

The strongest argument against approval is that the mediocre intent-to-treat results reflect the real world, where people don't take their pills. But approval of a treatment that works close to 100% when used once a day opens all sorts of doors for improvement. For example, communication with patients and with future trial participants can be much clearer and more definitive than communication in the iPrEx trial.

Also remember that much of the epidemic results from relatively few superspreaders. The limit of treatment as prevention is that it's almost impossible to identify and treat them in time. PrEP is better, because these people know they are personally at risk; they are likely to protect themselves if given clear messages and an opportunity to do so, eliminating all transmission through them -- a powerful strategy to fight the HIV epidemic.

AHF Debacle: Does Gilead Really Want Truvada Approved for PrEP?

Events in India (not reported in the U.S. so far) raise this question. The full story is summarized in "Anti-AIDS blitz sees pharma firms locked in ugly battle," at http://economictimes.indiatimes.com/articleshow/2586967.cms

The AIDS Healthcare Foundation campaign against Gilead re Truvada PrEP is a roll-out of a similar AHF campaign run almost four years earlier in India, against Cipla -- and clearly run on Gilead's behalf. AHF spent considerable money on full-page ads in Indian newspapers, apparently to get Cipla in trouble with the Indian government for charging less for medicines in Africa than it did in India. While AHF supposedly paid for the anti-Cipla campaign, Gilead gave AHF a grant for far more, according to The Economic Times article cited above. AHF had no visible motive to go after Cipla, but Gilead sure did; alone among Indian pharmaceutical companies making a Truvada generic, Cipla did not accept Gilead's licensing terms, but planned to fight Gilead's claims in Indian courts.

Why might Gilead secretly campaign today against use of its own drug for PrEP? It is not very hard to see why.

Gilead is stuck because it cannot feasibly charge a different and vastly lower price for the same pill for prevention. It's hard enough to promote prevention; now try adding over $13,000 per year out-of-pocket retail price ($13,816 -- $3,406.79 per 90 tablets, on drugstore.com today). This cost will be out-of-pocket in many if not most cases. The Truvada price is what the market will bear to help save a life, and the market will bear much less to relieve a risk people typically think doesn't apply to them, and don't like to think about at all.

Even 10% of the existing price will be too much for prevention. So there will be no significant market for Truvada PrEP, and no significant profit -- while Truvada for treatment remains an enormous gravy train for Gilead.

And if Truvada for PrEP is approved, Gilead will be the "heavy," consistently blocking control of HIV in the U.S., year after year after year. This will be dangerous for the company, especially in the context of so much need and pressure to reduce medical costs. Similarly, Gilead would be the heavy if it refused to apply for PrEP approval.

The AHF campaign to turn the gay community against Truvada PrEP has failed. But Gilead can get about the same benefit by applying to the FDA and being rejected.

Of course we cannot be sure of Gilead's or AHF's intentions, without reading minds. Maybe Gilead and AHF had a falling out. But in considering this application for Truvada PrEP, you should consider that it may be unlike any other you have ever seen. Whatever Gilead's intentions, the company clearly has strong economic and political incentives for its own application to fail.

John S. James
AIDS Treatment News
www.aidsnews.org


Note to readers: This very controversial FDA Antiviral Advisory Meeting will be May 10, near Washington DC; recently the schedule was changed to allow an extra hour of public comment. You can submit written comments until May 17; however, written comments had to be submitted by 4 pm today to be distributed in advance to the committee members. (We got ours in with less than 10 minutes to spare, due to computer hassles when using a Linux netbook at the FDA site.) Comments will be published by the FDA, but not immediately.

For more information about speaking and/or submitting comments, Google the FDA's docket number,  FDA-2012-N-0218

The AHF has been very active on this issue at the FDA. It has endless money, and it wants to win. We expect an echo chamber at the meeting.


Permalink: http://aidsnews.blogspot.com/2012/04/truvada-prep-gilead-ahf-our-statement.html


Notice re Comments below: Due to a computer problem, all comments submitted before 4:15 pm Eastern time today (April 30) disappeared -- except for #1. Your comment was not rejected. We never saw it. And we could not publish any comment ourselves.

A successful workaround was to change Blogger's 'Comment Location' setting from 'Embedded' to 'Full page'. Comments should work now. (We recommend this solution to anyone who publishes on Blogger, because 'Embedded' has long caused problems with  some browsers. You could lose some but not all comments with no notice, and commenters will think they were rejected when they were not.)

February 7, 2012

Act Up-Paris on pharmaceutical data exclusivity, ACTA

Please find below Act Up-Paris question to Karel De Gucht, European Commissioner for trade during a European Commission Civil society dialogue meeting* on trade, growth and development, that took place today in Brussels. 

* there was more industry representative than NGOs in the room.

Best, Pauline
-- 

"Mr De Gucht.

I represent Act Up-Paris, an organisation of people living with HIV based in France. But today, I bring you a message from hundreds of groups worldwide that have signed a call of action to denounce the European Commission's deadly trade policy. For four years you have negotiated a bilateral agreement with India, for three years you negotiated ACTA in a total lack of transparency.
You have repeatedly stated that these agreements will will not affect affordable medicines.

Starting on Friday, you will represent E.C during a summit in India.

How can you claim that data exclusivity will not have an impact when the European Parliament itself has asked that this provision not be put in an FTA with developing countries?

How can you state that ACTA and the enforcement provisions in the EU-India FTA will not affect medicines when european customs authorities continue to seize generic medicines in transit, like it happened again last November?

How can you ask India to implement TRIPS-plus provisions and state these will not affect access to medicines when the United Nations, the WHO, UNITAID, the Global Fund, the UN Special Rapporteur on the Right to Health have all condemned these provisions for affected treatment?

The statements of the European Commission have always been vague and aiming at confusing the citizens of Europe and millions of people in need to treatment worldwide. But they are not fooling anyone.

The European Commission speaks only for the profits of a few companies and not for the lives of millions across the world. Your FTA only aims at strengthening pharmaceutical companies monopolies. While the consequences for firms will be more profits, in the real world many people will die because they will not have access to treatments because of their price.

Across Asia, Latin America and Africa protests against the European Union are taking place. Yesterday in London, last Friday in Nepal, AIDS activists asked you to stop this policy that will take peoples lives.

We ask you to stop this deadly trade policy." 

Pauline Londeix

December 9, 2011

Russia: World AIDS Day ITPC events, patients need tenofovir


December 1, 2011
ST. PETERSBURG
FlASHMOB AND STARS
December 1, 2011. The following activists and volunteers of non-governmental organizations in St. Petersburg and Leningrad region joined together for an unprecedented event associated with the World AIDS Day under the slogan “Know and Live”:
E.V.A. Non-Profit Partnership to increase the quality of life for women living with and affected by HIV-infection and other socially significant diseases,MadStyleGroup Creative Holding, MadMedia Communication Project, Dance4life Social Project, International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru), Svecha Organization of People living with HIV, “Positive Dialogue” community of people living with HIV/AIDS, “Red Ribbon” Foundation and Salvation Army volunteers.
The event was held in two stages, the first part being a march from Anichkov Bridge to Gallery Trade Centre 6.30 p.m, joined by more than 200 people. The young activists walked along Nevskiy Prospect, telling the passers-by about the World AIDS Day. The participants stopped beside several subway stations, handing out booklets about HIV/AIDS and red ribbons to the passers-by with the following words: “HIV is not transmitted via information. Take care of your own health and the health of those you love”. In total, more than 2 000 copies were distributed. The second part took place in Gallery Trade Centre from 7.00 p.m. till 7.40 p.m. The people who were in the Gallery at that time got a chance to learn more about HIV epidemic, take part in a dance flashmob and enjoy a show involving stars of the Russian show business, T9 and In2nation pop groups and “Studio 17” dance group.
Another symbol of the event was a heart, to which everyone caring about the epidemic, being ready to take the responsibility for their own lives, and empathizing with those affected by the epidemic, could tie a red ribbon. By the event of the event, the heart was red with ribbons, and even after the end people with kept coming and tying their ribbons to the heart.
All the participants said that they managed to draw the attention of people in the Gallery and on the streets. In total, more than 400 people took part in the event.
DECEMBER 1 – MOSCOW
UNSANCTIONED PROTEST ACTION BESIDE THE MINISTRY OF HEALTH
Yet another protest action was held in front of the Ministry of Health of the Russian Federation by Patients Control Movement, with the funeral orchestra and two coffins representing failing treatment and prevention programmes in the country, leading to numerous deaths. The activists state that the absence of mandatory treatment guidelines puts the whole AIDS response in the country at risk. At the same time, several regions in Russia still face stock-outs of diagnostics and regimen changes due to non-clinical indications (as is underlined by the report issued within the framework of the Simona+ monitoring project). Russian patients still have no access to tenofovir, despite the facts that tenofovir-based regimens are included in the WHO guidelines. 

The event received broad coverage in the mass media, some activists were detained by the police and then released.

PRESS CONFERENCE HELD BY THE MINISTRY OF HEALTH
One of the Patients Control Initiative representatives took part in the press conference of MoH. At the end of the press conference, Ilya Lapin asked questions about the unsolved problems, namely lack of test kits, nevirapine for children, which has not been purchased by MoH, and absence of HIV treatment guidelines.

PRESS CONFERENCE WITH V. POZNER AND DANCE4LIFE
Alexandra Volgina spoke about problems with access to diagnostics, stock-outs of ART, lack of communication with MoH, and other issues raising concerns among the activists regarding access to HIV treatment in Russia.

ARTICLE IN ROSSIYSKAYA GAZETA (THE RUSSIAN NEWSPAPER)
Gaps in the list – Russia lacks essential medications for combating AIDS
Circulation: 185 445 copies (as of 2nd half of 2010). Coverage: 44 cities of Russia, with regional inserts and issue-related supplements. The newspaper issues a series of books with state documents and comments.

FAX ATTACK ON MoH

December 1
- 50 organizations from different countries sent a fax to MoH, drawing their attention  to the issue of access to tenofovir and nevirapine.
Nevirapine for children has not been purchased by the MoH, despite the fact that only one month is left till the end of the year.
Tenofovir is not included in the list of essential drugs, and MoH does not purchase it for Russian patients.

On average, a fax from activists was sent every ten minutes.



--
Best regards,
Sergey Golovin 
Public Relations Officer
Skype: sergej.golovin

August 12, 2011

April 25, 2011

HIV PrEP Explained: Critical Prevention Opportunity

by John S. James, AIDS Treatment News, April 25, 2011


The Good News

In late 2010 the New England Journal of Medicine published an authoritative report of a trial of PrEP (pre-exposure prophylaxis) in over 2,000 HIV-negative but high-risk gay men, showing that one pill a day of the approved HIV medicine Truvada could prevent HIV infection.[1] Science magazine listed this study as one of the top 10 achievements of 2010 [2]; and President Obama issued a statement about this trial.[3] For background, see [4].

The headline result is that Truvada was 44% effective (compared to placebo) in preventing HIV transmission in this population. This sounds disappointingly low. Why then is the study considered so important?

Much of the answer is that 44% is not the whole story. In the group randomly assigned to take a placebo, 64 became infected during the study; in the group randomly assigned to take Truvada, 36 became infected. Because the sizes of the groups were almost exactly equal (1251 participants, vs. 1248), you can compute the 44% by simple arithmetic.

Fortunately the study did blood testing of the 36 people who became infected despite being assigned to take Truvada, to see if they were really taking the drug. About 90% of them (33 of the 36) had no drug in their body when tested, at the last blood draw before they were found to have HIV. (Truvada consists of two drugs, and no detectable level of either drug was found in any of the 33 people.) The drug-level testing methods had been carefully validated, and can detect the active form of at least one of the drugs two weeks after people stop using the pills. Clearly these study participants had not been taking the medicine when tested. When these trial volunteers who were assigned to take the drug (but had not in fact taken it) were not counted, the effectiveness was not 44%, but over 90%.

It gets better. The other 3 participants who became HIV infected during the trial had very low levels of the active forms of the drugs, just above the limit of detection. Clearly they had taken some Truvada, but were far from using it as directed.

So of the 100 participants who became HIV-infected during this trial, 97 had not used Truvada at the time of the last blood draw -- and the other 3 had used it very poorly. Of those who actually took one Truvada pill per day throughout the study, not one became HIV-infected during this trial (vs. 64 of those who had been given the placebo). So for those who actually used the drug as directed, throughout the entire study, it was 100% effective in this trial, which had over 1,000 high-risk gay men assigned to take Truvada.

But the blood draws occurred in this study at weeks 4, 8, 12, 16, 24, and then every 12 weeks. So we cannot rule out the possibility that one or more people who had not taken Truvada for about two weeks or more before one of those visits, then got religion after the visit, and starting taking the pills daily -- yet got infected despite having adequate drug levels. This seems unlikely in view of the overall findings. But if it did happen, then it would mean that the protection was less than 100% in those who were using the drug. It was not possible to have everyone wear a device that that could record drug levels continuously -- and also tell exactly when they got HIV. So there is no way to be sure that nobody had enough drug in their body when they were infected. For this reason, 100% effectiveness is not claimed or reported.[5]

Still, the fact remains that Truvada for HIV prevention worked very well in this trial. Truvada when used properly (once a day, throughout the trial) completely prevented HIV infection, in a study of over 1,000 people -- when a comparable, randomly chosen group of 1,000 other people given a placebo had 64 HIV infections during the same time. Almost no drug for anything works this well.


Using PrEP Now

Since doctors can legally prescribe Truvada for prevention now, the U.S. CDC (Centers for Disease Control and Prevention) in January 2011 published interim guidance for physicians who want to use it to prevent HIV infection in high-risk HIV-negative men who have sex with men.[6,7]. Guidance will change as more information becomes available from other studies currently ongoing.

The main obstacle now is the price. Gilead Sciences, which holds the patent on Truvada, charges about 100 times as much for Truvada in the U.S., as other companies charge profitably for the same generic medicine in countries where Gilead's patent does not apply. And unless the FDA approves a formal "indication" for prevention use, insurance is unlikely to pay. This means that you can get Truvada for prevention in the U.S. today -- if you have over $12,900 per year to spend out of pocket -- or possibly, very good health insurance. (Gilead raised the price early in April, 2011; on April 18 we checked retail prices on Drugstore.com, which offers 90 once-daily pills for $3,180,90.)

Clearly PrEP will not be used enough to impact the epidemic, if individuals must pay so much out of pocket. (Just taking a $35 pill before sex is not expected to work. The body must convert both drugs into their active forms, which takes time.)


Adherence Issues

Some of the media discussion on Truvada adherence (taking one pill a day consistently) vs. effectiveness for HIV prevention is confusing, because in this study adherence was measured in different ways. Drug-level testing was clearly the gold standard -- while other methods, like asking people how often they took the pills, or counting pills returned, were often confusing, and much less reliable.

If any drug is so hard to take correctly that people seldom do so, then that drug is much less valuable. This is part of the reason that studies are most conservatively reported as “intent to treat” (counting everybody assigned to take the drug or other treatment as being treated -- even if they never actually take any of that treatment at all), instead of “on treatment” (counting only those who actually did take the drug -- partially a self-selected group, which could make the trial results hard to interpret). The purpose of intent-to-treat reporting is to make the study results both more accurate and also more relevant to social policy -- since doctors can only recommend a treatment, not make sure it gets used. In this case, the difference in result was huge: 44% effective, vs. over 90% -- or even close to 100% effective in this trial (depending on how you count the three participants with extremely low drug levels who were using the medication very poorly).

Why did so many of the study participants not take the Truvada?

No one knows for sure at this time. But something unusual and unexpected happened in this study. This clinical trial took place at 11 sites in 6 countries -- with two of the 11 sites in the United States (Boston and San Francisco -- with 113 U.S. participants on Truvada, 114 on placebo). And adherence at the U.S. sites was much better than at the non-U.S. sites -- 97% among all the U.S. participants, considered extremely good, compared to far less overall. The "44% effective" headline just averages these very different situations.

We know of three theories about this difference: (1) The U.S. participants were about 10 years older on the average (though this would hardly explain the huge adherence differences observed); (2) Many of the non-U.S. participants were living at home and probably not “out” to their families, so they would have needed to conceal their participation in the study, making adherence difficult; or (3) Boston and San Francisco have excellent HIV treatment access, perhaps the best in the U.S., while in many countries most people with HIV are dying with no treatment at all. So trial participants may have given or sold their pills to someone with immediate need.

We think that the latter is most likely.

Whatever the reason, the excellent U.S. adherence shows that people can use the drug properly for prevention. And in the future, patients will know that they are getting the active drug (not a placebo), and that it has been proven to work -- both of which should boost adherence. Researchers need to find out what went wrong at some of the sites, and learn how fix it.

But the bottom line is that we do have proof of principle that Truvada prophylaxis can work in high-risk gay men, and prevent close to 100% of the HIV infections that would otherwise occur.


Who Should Take Truvada?

No one we know thinks that all gay men should take Truvada.

But using this new prevention option in a targeted way should help a lot to control the HIV/AIDS epidemic. Remember that in any epidemic, if each person infected infects fewer than one other person on the average, and this can be maintained, then the epidemic will end.

And it turns out that a disproportionate amount of transmission takes place very early in someone's HIV infection -- when viral load is extremely high, but people do not know and seldom even suspect that they are infected, so they are much less careful about risk to others, than if they did know their status.

Also, in HIV as in most epidemics, a few so-called “superspreaders” account for a very disproportionate amount of transmission.[8] In HIV, they are much like those in the Truvada prevention study -- high risk, meaning that they have many sexual partners, especially with unprotected anal intercourse. (In the iPrEx study, volunteers were interviewed by the researchers, and those considered not to be at high risk were rejected -- so that the trial would be more likely to answer the question of whether or not this PrEP treatment worked.)

So far, the big problem in targeting early infection and/or superspreaders has been getting them diagnosed in time. Many are not aware of being sick at all during their early “primary” HIV infection, when they are so dangerous to their sexual partners. Most do get sick, but with the flu-like symptoms of an ordinary viral infection. They or their doctors have no reason to suspect that they have HIV. And if they do take a standard HIV antibody test, they will test negative even though they have a very high HIV viral load, because the body has not formed antibodies against HIV yet.

Recently there has been much interest in trying to stop the HIV epidemic by a policy of “test and treat” -- find people and get them into treatment right away, because on treatment their HIV viral load will be hundreds of times less than before, and they will be much less likely to transmit the infection to anyone else. One recent study [9] concluded that test-and-treat alone will not be enough in the United States, where only 19% of people with HIV have an undetectable viral load -- a "shocking" figure due largely to poor access to care. And it is very hard to find newly infected people soon enough.


PrEP's Big Advantage with Test-and-Treat

With effective PrEP, the problem of early HIV diagnosis goes away. If the high-risk individual never gets infected in the first place, a whole branch of the epidemic tree can be cut off. And as we explained above, the effectiveness of Truvada PrEP in gay men has been close to 100% so far, when it has been used properly (one pill a day, taken consistently).

The way to identify high-risk individuals is to let them identify themselves. After a conversation with their doctor (or a specialist physician at an AIDS organization), and with testing to make sure they do not already have HIV (in which case they would need medical management, not PrEP), they should be able to get a one-pill-a-day supply of the drug without obstacles. Periodic testing could be required, to guard against side effects (such as possible kidney damage), and to make sure the patient is still using the drug, and does not have HIV.

Of course there will be some worried well who end up taking Truvada for prevention even though they do not need to. The doctor can explain the small but real risks of doing so. Truvada is one of the least problematic AIDS medicines.

Note that the “superspreaders” are usually the same high-risk individuals who have many sexual partners and do not take needed precautions. They know who they are. And their own interest in protecting themselves closely parallels the public interest in stopping the HIV epidemic.

Notice that PrEP gives people a new, big incentive to get tested -- the chance to avoid HIV entirely if they get the good news, perhaps even without changing their sexual practices -- not just the chance to start treatment earlier in case of bad news.

We need combination HIV prevention; no one size fits all. But we now know that Truvada PrEP can provide very good protection for high-risk men who have sex with men. And by doing so, it will also be a major tool to help control and eventually end the global HIV epidemics.


Note on FEM-PrEP Trial Closing

Shortly before we went to press, a similar Truvada PrEP trial in women failed, and was closed early. It was ended because exactly the same number of women were infected in the group assigned to take Truvada, as in the group assigned to take the placebo. The study's Independent Data Monitoring Committee secretly examined these interim results, and determined that this trial was very unlikely to show that Truvada PrEP worked in the women. Therefore, the trial was stopped, due to "futility."

Why did the same iPrEx study drug work in men but not in women? No one knows. Blood samples were saved, and drug-level testing and other data will need to be analyzed, to see what can be learned.

There are at least two plausible theories as to why this may have happened:

(1) The iPrEx trial focused on anal HIV transmission, FEM-PrEP on vaginal. It is possible that oral Truvada does not block vaginal transmission, probably because it does not reach high enough levels in the vagina.

(2) There is also another possibility. As explained above, the iPrEx trial worked much better at the U.S. sites (Boston and San Francisco) -- than at other sites, where participants would often have strong reason to give their medication to someone who was sick due to HIV, and not tell the researchers. All of the FEM-PrEP sites were in Africa, where access to life-saving HIV treatment is much worse than in Boston or San Francisco. Unlike iPrEx, FEM-PrEP had no U.S., European, or other sites where no one would need to divert the pills to save the life of a family member or friend.

Neither one of these two possibilities would contradict the iPrEx results -- or the CAPRISA 004 results. In either case, both these studies remain as solid as they ever were.

Note: Truvada alone is not considered proper HIV treatment today, since at least one other anti-HIV drug is needed to more fully suppress the virus and prevent it from developing drug resistance. But if no other treatment is available, Truvada alone might restore someone with AIDS to health and save their life for some time. It is probably better than any HIV treatment anywhere before 1996. Of course it would be much better to take Atripla (or a generic equivalent, or a comparable combination); Atripla is Truvada plus a third drug that works well with it, a modern HIV treatment in one pill per day.

We will report new information as it becomes available.


References and Footnotes

[1] Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. New England Journal of Medicine (full text free); December 30, 2010, published online November 3, 2010, http://www.nejm.org/doi/full/10.1056/NEJMoa1011205.

Later analysis of the trial, not ready for the above publication, was included at the 18th Conference on Retroviruses, especially in the March 1, 2011, 10:00 a.m. session, "Advances in PrEP," at http://www.retroconference.org/2011/data/files/webcast_2011.htm (you need to select 'Tuesday'). Besides the Scientific Overview, also note “Adherence Indicators and Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men," and "PrEP Drug Levels in the iPrEx Study,” later in the same session.

[2] Science Magazine Names USAID-Funded HIV Research As Top 10 Breakthrough of the Year. [Both the CAPRISA trial (1% tenofovir vaginal gel for women) and the iPrEx trial (Truvada, a tenofovir + FTC pill for men) made the top-10 list.] Medical News Today, December 28, 2010, http://www.medicalnewstoday.com/articles/212499.php

[3] White House press release, November 23, 2010, http://www.whitehouse.gov/the-press-office/2010/11/23/president-obama-welcomes-new-hiv-prevention-research-results

[4] Background note: This international clinical trial is called iPrEx, which is an abbreviation for the Spanish name of the study; many participants were in Spanish-speaking countries. It used Truvada, a common HIV treatment marketed by Gilead Sciences; Truvada consists of two drugs, tenofovir and emtricitabine, combined in a single pill taken once a day. A related HIV prevention study in women, using a vaginal gel containing tenofovir, was also successful (CAPRISA 004, also recognized in the Science top-10 list. But a prevention trial using Truvada in women recently failed; see the discussion of FEM-PrEP in the text above.

[5] A major reason the "44%" effective (instead of "close to 100%") is widely headlined, instead of is that researchers are expected to highlight the study analysis that they planned in advance to do -- not other analyses that they may choose after looking at the study results. In this case, the planned analysis was the overall HIV-prevention result, with all the study sites considered together. The huge difference between the U.S. and some of the other sites was not expected.

The U.S. sites showed proof of principle that taking one Truvada pill a day can work very well to prevent HIV infection. The sites where people did not take the pills showed that these sites had other problems, which need to be investigated and addressed.

Those interested in statistical methods will note that headlining the pre-planned analysis turned out to be misleading in this case, because of the emergence of a "black swan" -- something totally unexpected which changes the entire picture. As seen also in the financial world (http://www.guardian.co.uk/business/2011/apr/05/world-economy-faces-black-swans-imf-strauss-kahn), modern analysis does not handle black swans well. In clinical research, a major purpose for favoring hypotheses stated in advance is to prevent researchers from falsely enhancing the value of their study by building hypotheses around the resulting data -- including its random variations.

We believe that an analysis revolution is possible here, since there must be better ways to handle these problems that what is done today. As a stopgap, we suggest letting medical researchers claim a black-swan exemption, when justified by an unexpected result that changes the whole picture -- giving them more freedom to highlight interpretations developed after they had seen the results, while also calling in more scrutiny from other professionals, to check that they were using the exemption in ways that were not misleading, and that made practical sense overall.

[6] Interim CDC Guidance on Pre-Exposure Prophylaxis for HIV Prevention in MSM (short overview with highlights for physicians, January 28, 2011), http://aids-clinical-care.jwatch.org/cgi/content/full/2011/214/1

[7] Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men (the official document), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm

[8] On the importance and the difficulty of reaching superspreaders in HIV, see: Autonomous targeting of infectious superspreaders using engineered transmissible therapies. PLoS Computational Biology; March 17, 2011, http://www.ploscompbiol.org/article/info%3Adoi%2F10.1371%2Fjournal.pcbi.1002015.

[9] Test-and-treat not enough to control HIV epidemic in the US, http://www.aidsmap.com/Test-and-treat-not-enough-to-control-HIV-epidemic-in-the-US/page/1724334/

Note: This post is Part I. We are researching Part II, on obstacles and opposition to using Truvada PrEP for individual protection, or to help end the HIV/AIDS epidemic. Part II will be controversial.

March 10, 2011

Changes to AIDS Treatment News blog

I'm planning changes to this blog and would like to hear what you think (either publicly by a comment, or privately by email to aidsnews@aidsnews.org).

My current thinking is to move the news stories to the right-hand column (via Twitter, but you do not need to use Twitter to read them). Then the main column of the blog will be for discussion, usually around one or more of the news stories.

The previous format was not good for discussion - largely because readers seldom saw blog comments, since they quickly got buried by all the news items coming in. And Twitter encourages many equal voices - important for community discussion and idea development.

The new format should result in more news stories, fewer blog posts, more interaction, and more in-depth discussion.

Thoughts?