[e-drug] Why it's time to say goodbye to stavudine

E-DRUG: Why it's time to say goodbye to stavudine
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Please find below a short 'debate' article just published in the Southern
African Journal of HIV Medicine (SAJHIV), titled: "Why It’s Time To Say
Goodbye To Stavudine ... Everywhere."

In this article, we articulate our concerns regarding a head-to-head trial
comparing low-dose (20mg) stavudine (d4t) to tenofovir (TDF) as part of a
regimen with 3TC and EFV, which will begin enrollment next month in India,
South Africa, and Uganda. MSF and the co-authors from TAC, TAG, and
i-base have met with the sponsor of the trial, the Bill and Melinda Gates
Foundation, multiple times over the last two years to express these
concerns directly. See also a joint civil society letter (link below).

In short, we believe that the trial length (96 weeks) is too short a
duration to account for toxicity and associated adverse effects with
longer-term use of stavudine. Furthermore, the known clinical benefits of
tenofovir outweigh even the best-case scenario, should efficacy of
stavudine d4t 20mg be on par with TDF in terms of achieving viral
suppression.

Related to this, we'd also like to direct your attention to a report of
recommendations developed by participants to a meeting convened by MSF,
Esther, and SOLTHIS on the optimal usage of the existing ARVs or those
currently in the pipeline. This report also articulates an advocacy agenda
for promoting access to better drugs and tools for the near future.

One message from that meeting is clear: while we can attribute much of the
last decade’s achievements in ART coverage scale-up to the availability of affordable d4t, we do not need to continue to accept compromising clinical management of HIV. Fortunately, with the changes that most countries have put in place, treatment protocols are now more closely resembling those available to patients in North America, Europe, and other countries. We are slowly but surely or closing the equity gap in HIV treatment protocols.

This next era of treatment scale-up has the potential to be defined by
earlier initiation of ART at lower levels of health systems, requiring
fewer clinical visits or even peer-managed care (e.g. Community ART Groups
in Mozambique). To achieve this ambition, we need to place primacy not
only on effectiveness and robustness, but on treatment strategies that
have lower pill counts, fewer side effects, and lower monitoring
requirements.

In every sense, we should be going forward, not backward, in improving HIV
care, and opting for the most robust options along the way.

Tido von Schoen-Angerer, MD, MSc
Executive Director, Access Campaign
Médecins Sans Frontières International
Tido.von.SCHOENANGERER@geneva.msf.org

"Why It’s Time To Say Goodbye To Stavudine ... Everywhere." SAJHIV
article, March 2012:
http://www.sajhivmed.org.za/index.php/sajhivmed/article/view/813

MSF Issue Brief: Rationale for Tenofovir as the First Choice for
First-Line Treatment of HIV, March 2012:
http://www.msfaccess.org/content/rationale-tenofovir-first-choice-first-line-treatment-hiv-0

Joint civil society letter, 14 December 2011:
http://www.msfaccess.org/content/joint-letter-bill-melinda-gates-foundation-clinical-trial-comparing-stavudine-and-tenofovir

MSF, Esther, SOLTHIS: Antiretroviral Sequencing Meeting Report, 22-23
September 2012
http://www.msfaccess.org/content/antiretroviral-sequencing-meeting-report

E-DRUG: Why it's time to say goodbye to stavudine (2)
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Hi Chikuta,

I noticed that stavudine is still used here, but in many countries it has
been completely removed.

FYI

regards,

Murray
--
Independent Consultant
Pharmaceutical Policy, Systems and Public Health Development.
Email: pharmdevelop@gmail.com

Adjunct Associate Professor Pharmacy
James Cook University
Townsville, Queensland, Australia
Email: murray.bailey@jcu.edu.au

PO Box 1893,
Potts Point, Sydney NSW 1335,
Australia
telephone +61 (0)414 310 338

E-DRUG: Why it's time to say goodbye to stavudine (3)
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Dear Tido and colleagues,

A US Senator has asked me to look into how more, or less, innovative drug companies have been over the past 10-15 years in the development of AIDS drugs? To what extent have they used patent protection and other privileges (accelerated review, etc) to dig deep and find superior new drugs and address real needs? Or to what extent have they used these to develop a lot of marginally different, better, or worse new drugs? In sum, how well are the current ways of rewarding innovation in HIVAIDS drugs (through high prices) working?

If you or colleagues have materials on this question or can recommend reports assessing the degree of clinical advances vs minor variations, I would greatly appreciate your help. Meantime, Joel Lexchin and I have completed an analysis of "innovation" in R&D and addressed the question of what are we getting for the billions it costs.

With best regards,
Donald

Donald W. Light
Cell: 609-216-0071
Professor, UDMNJ-SOM
Lokey Visiting Professor, Stanford University
Visiting Researcher, Center for Migration & Development,
Princeton University
dlight@princeton.edu