{"id":10190,"date":"2010-04-02T11:23:28","date_gmt":"2010-04-02T11:23:28","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=10190"},"modified":"2013-08-08T12:36:36","modified_gmt":"2013-08-08T12:36:36","slug":"msf-criticise-abbott-over-new-ritonavir-formulation","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/10190","title":{"rendered":"MSF criticise Abbott over new ritonavir formulation"},"content":{"rendered":"

MSF press\u00a0statement<\/strong><\/p>\n

Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration have recently approved the long-awaited heat-stable 100mg tablet\u00a0version of ritonavir, the antiretroviral booster drug produced by Abbott Laboratories.<\/strong><\/p>\n

The market authorisation of a heat-stable version of ritonavir as a separate pill finally ends both the stranglehold by Abbott on the treatment options\u00a0available to people living with HIV\/AIDS and the medical double standards the company has promoted by failing to prioritise the development of safer\u00a0versions of its medicines. Protease inhibitors (PIs) are the cornerstones of second-line AIDS therapy, as set out in World Health Organization (WHO)\u00a0guidelines.<\/p>\n

PI-based regimens recommended in the guidelines include a booster drug, to be taken in conjunction with the PI, in order to make the regimen more\u00a0effective. Ritonavir is still the only approved booster in existence.<\/p>\n

Although Abbott has been marketing the heat-stable version of ritonavir since 2005, this has only been as a fixed-dose combination with its own protease\u00a0inhibitor, lopinavir – not as a separate heat-stable pill. Until now, \u0091standalone\u0092 100 mg ritonavir was only available in a soft-gel formulation that\u00a0requires refrigeration, making it extremely ill-suited for use in developing countries. This in turn severely restricted the choice of protease inhibitors
\nfor people on antiretroviral treatment, particularly in the developing world, as the use of all PIs other than Abbott\u0092s own lopinavir came with\u00a0refrigeration constraints.<\/p>\n

By failing to move faster on creating a separate ritonavir tablet, the company therefore built a market advantage for its own PI lopinavir, and made the\u00a0use of other life-saving protease inhibitors less practical.<\/p>\n

Abbott\u0092s delay extends to promoting medical double standards. The soft-gel version of ritonavir comes with more side effects and more dietary restrictions\u00a0than the heat-stable version. In fact in 2007, the EMA raised this as a public health concern with Abbott. The absence of a heat-stable ritonavir also\u00a0restricted the possible use of second-line AIDS drugs for patients co-infected with tuberculosis.<\/p>\n

As a result of Abbott\u0092s inaction, many people living with HIV have therefore been deprived of additional, improved and vital treatment options.<\/p>\n

Looking ahead, one particular area of need is the development of a heat-stable combination of atazanavir and ritonavir, one of the two PIs (with\u00a0lopinavir\/ritonavir) recommended by WHO for second-line treatment. A fixed-dose combination of atazanavir\/ritonavir would in fact present considerable\u00a0advantages over lopinavir\/ritonavir, as it will reduce the pill burden from four to one pill a day.<\/p>\n

Other PIs that require boosting with ritonavir are darunavir (which WHO indicates may form part of a future third-line antiretroviral therapy), and nearly\u00a0all other PIs are more effective when used with a ritonavir booster. But to date, Abbott has not allowed manufacturers to produce any of these PIs in a\u00a0fixed-dose combination with ritonavir.<\/p>\n

It is hoped that generic manufacturers in developing countries will move forward with the development and registration of such boosted heat-stable PIs as\u00a0fixed-dose combinations. Where there are potential patent barriers that prevent them from doing so, use should be made of safeguards in patent laws to\u00a0ensure these are overcome.<\/p>\n

MSF calls on Abbott to:<\/p>\n