[Ip-health] MSF addresses MGH study on implications of switching from branded to generic antiretrovirals for HIV

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Wed Jan 16 09:12:20 PST 2013

*Médecins Sans Frontières/Doctors Without Borders addresses study by
Massachusetts General Hospital on implications of switching from branded to
generic antiretrovirals for HIV*

*Study on generic antiretrovirals ignores fact that patents prevent use of
more affordable patient-friendly combination drugs*

The just-released study led by Massachusetts General Hospital in the Annals
of Internal Medicine stating that switching patients from the branded
combination antiretroviral ‘Atripla’ to generics could be therapeutically
‘less effective’ is misleading and misses a big part of the picture. The
harmful role played by patents in blocking the use of quality-assured
generic combination drugs is overlooked. The article further conflates
evidence that single-pill "fixed-dose combination" HIV drugs lead to better
treatment outcomes with the false notion that generic medicines themselves
may lead to worse outcomes. [1] <#_ftn1>,[2] <#_ftn2>

The study concludes that switching to generic regimens in the US could
result in savings of US$1 billion in the first year alone, but this
important and hard-hitting conclusion is obscured by the fact that the
quality and efficacy of generic medicines is erroneously questioned.

In countries where patents do not block their use, generic versions of
‘Atripla’ (the triple fixed-dose combination of
tenofovir/emtricitabine/efavirenz, and its therapeutic
equivalent[3]<#_ftn3>using lamivudine instead of emtricitabine), are
available for between
US$132 and $207 per person per year, less than 1% of the US price of up to
$30,000 per year. These generics are largely produced in India, are
quality-assured by the World Health Organization, and are used by MSF and
the US-government’s PEPFAR treatment programme in developing countries.

Fixed-dose combination antiretrovirals were first developed by generic
manufacturers in India because the individual medicines weren’t patented
there, allowing them to be combined into one pill. MSF's experience
providing HIV treatment and a number of studies have shown that fixed-dose
combinations make adhering to treatment easier for patients. MSF, with the
University of Montpellier's Research Institute for Development in France,
conducted a clinical trial in 2004, which found that generic fixed dose
combinations were as effective as the brand version. [4] <#_ftn4>

Although two of the three drugs in the combination will be available as
generics in the US, the third drug, tenofovir disoproxil fumarate (TDF) is
still patented by Gilead Sciences. The patents on this drug are what block
the production of combinations of TDF with the two generics and prevent
patients in the US from accessing generic versions of the Atripla
combination. While the basic patent for tenofovir has expired, the company
was able to extend its monopoly and obtain additional patents on the drug,
and combinations that include it, through a process known as
‘evergreening,’ whereby pharmaceutical companies extend the life of a
patent by making a small alteration to an existing compound. Generic
versions of TDF will not be available in the US before 2018.

“This study fails to take into account the fact that drug patents are what
prevent patients from being able to stay on an easier-to-take and more
affordable combination pill,” said Sharonann Lynch, HIV/AIDS Policy Advisor
for MSF. “Generic versions of this combination exist for $200 per person
per year in countries where patents do not block their use – less than one
percent of what they cost in the US. MSF and PEPFAR use these generics that
are quality-assured by the World Health Organization and the US FDA, and
work just as well as the brand versions.”


[1] <#_ftnref1> Bangsberg DR, Ragland K, Monk A, Deeks SG. A single tablet
regimen is associated with higher adherence and viral suppression than
multiple tablet regimens in HIV+ homeless and marginally housed people.
AIDS. 2010;24:2835- 40. [PMID: 21045636]

[2] <#_ftnref2> Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW,
Gross R, et al. Guidelines for improving entry into and retention in care
and antiret- roviral adherence for persons with HIV: evidence-based
recommendations from an International Association of Physicians in AIDS
Care panel. Ann Intern Med. 2012;156:817-33, W-284-294. [PMID: 22393036]

[3] <#_ftnref3> World Health Organization. Technical update on treatment
optimization: pharmacological equivalence and clinical interchangeability
of lamivudine and emtricitabine: a review of current literature. Geneva:
World Health
Organization; June 2012. Available:

[4] <#_ftnref4> Christian Laurent, Charles Kouanfack, Sinata Koulla-Shiro,
Nathalie Nkoué, et al. Effectiveness and safety of a generic fixed-dose
combination of nevirapine, stavudine, and lamivudine in HIV-1-infected
adults in Cameroon: open-label multicentre trial. Lancet 2004; 364: 29–34

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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