[Ip-health] MSF: approval of heat-stable ritonavir ends years of neglect by Abbott

[James ARKINSTALL]

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Heat-stable ritonavir approved:=0D
Years of medical double standards and stranglehold by Abbott come to an=0D
end=0D
=0D
Both the European Medicines Agency (EMEA) and the U.S. Food and Drug=0D
Administration have recently approved the long-awaited heat-stable 100mg=0D
tablet version of ritonavir, the antiretroviral booster drug produced by=0D
Abbott Laboratories.=0D
=0D
The market authorisation of a heat-stable version of ritonavir as a=0D
separate pill finally ends both the stranglehold by Abbott on the=0D
treatment options available to people living with HIV/AIDS and the medical=
=0D
double standards the company has promoted by failing to prioritise the=0D
development of safer versions of its medicines.=0D
=0D
Protease inhibitors (PIs) are the cornerstones of second-line AIDS=0D
therapy, as set out in World Health Organization (WHO) guidelines.=0D
PI-based regimens recommended in the guidelines include a booster drug, to=
=0D
be taken in conjunction with the PI, in order to make the regimen more=0D
effective.  Ritonavir is still the only approved booster in existence.=0D
=0D
Although Abbott has been marketing the heat-stable version of ritonavir=0D
since 2005, this has only been as a fixed-dose combination with its own=0D
protease inhibitor, lopinavir - not as a separate heat-stable pill. Until=
=0D
now, =E2=80=98standalone=E2=80=99 100mg ritonavir was only available in a s=
oft-gel=0D
formulation which requires refrigeration, making it extremely ill-suited=0D
for use in developing countries.  This in turn severely restricted the=0D
choice of protease inhibitors for people on antiretroviral treatment,=0D
particularly in the developing world, as the use of all PIs other than=0D
Abbott=E2=80=99s own lopinavir came with refrigeration constraints.=0D
=0D
By failing to move faster on creating a separate ritonavir tablet, the=0D
company therefore built a market advantage for its own PI lopinavir, and=0D
made the use of other life-saving protease inhibitors less practical.=0D
=0D
Abbott=E2=80=99s delay extends to promoting medical double standards.   The=
=0D
soft-gel version of ritonavir comes with more side effects and more=0D
dietary restrictions than the heat-stable version. In fact in 2007, the=0D
EMEA raised this as a public health concern with Abbott.  The absence of a=
=0D
heat-stable ritonavir also restricted the possible use of second-line AIDS=
=0D
drugs for patients co-infected with tuberculosis.=0D
=0D
As a result of Abbott=E2=80=99s inaction, many people living with HIV have=
=0D
therefore been deprived of additional, improved and vital treatment=0D
options.=0D
=0D
Looking ahead, one particular area of need is the development of a=0D
heat-stable combination of atazanavir and ritonavir, one of the two PIs=0D
(with lopinavir/ritonavir) recommended by WHO for second-line treatment. A=
=0D
fixed-dose combination of atazanavir/ritonavir would in fact present=0D
considerable advantages over lopinavir/ritonavir, as it will reduce the=0D
pill burden from four to one pill a day.=0D
=0D
Other PIs that require boosting with ritonavir are darunavir (which WHO=0D
indicates may form part of a future third-line antiretroviral therapy),=0D
and nearly all other PIs are more effective when used with a ritonavir=0D
booster. But to date, Abbott has not allowed manufacturers to produce any=
=0D
of these PIs in a fixed-dose combination with ritonavir.=0D
It is hoped that generic manufacturers in developing countries will move=0D
forward with the development and registration of such boosted heat-stable=
=0D
PIs as fixed-dose combinations. Where there are potential patent barriers=
=0D
that prevent them from doing so, use should be made of safeguards in=0D
patent laws to ensure these are overcome.=0D
=0D
MSF calls on Abbott to:=0D
=C2=B7 Register heat-stable ritonavir tablet widely in developing countries=
.=0D
=C2=B7 Ensure that the price is affordable to patients in all developing=0D
countries (Abbott=E2=80=99s discounted price of US$83 per person per year f=
or the=0D
heat-stable and soft-gel versions of ritonavir is only available for the=0D
absolute poorest countries).=0D
=C2=B7 Develop a more adapted heat-stable paediatric formulation of=0D
lopinavir/ritonavir (such as soluble granules or sprinkles) for young=0D
children who can not swallow the existing tablet.=0D
=C2=B7 Facilitate access to more affordable versions of ritonavir and=0D
fixed-dose combinations containing ritonavir by putting the patents on=0D
ritonavir into the Patent Pool for HIV medicines currently being set up by=
=0D
UNITAID.=0D
=0D
=0D
- - - - - - - - - - - - - - - -=0D
James ARKINSTALL=0D
=0D
Managing Editor=0D
M=C3=A9decins Sans Fronti=C3=A8res - Campaign for Access to Essential Medic=
ines=0D
www.msfaccess.org=0D
=0D
+33 1 40 21 2837 (office)=0D
+33 6 13 99 7751 (mobile)=0D
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Follow us on Twitter:  http://twitter.com/MSF_access=0D
Join us on Facebook:  http://www.facebook.com/MSFaccess=0D