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Treatment outcomes no better with single tablet regimens than individual tablets
Roger Pebody, 2015-04-23 18:10:00
One pill a day HIV treatments such as Atripla, Stribild and Eviplera have the same rates of virological failure, drug resistance and side-effects as multiple tablet regimens, according to a meta-analysis presented to the British HIV Association conference in Brighton today. Single tablets cost the NHS five times more but have unproven clinical benefits, Andrew Hill of the Chelsea & Westminster Hospital said.
Typically, new drugs stay on patent for 20 years. This means that the pharmaceutical company which originally developed the drug has the exclusive right to sell it. Following this, other manufacturers can produce generic versions of the drug, which are equivalent to the branded product, but are typically 80% cheaper.
The NHS has been encouraging the increased use of generic equivalents wherever possible across a wide variety of health conditions.
With the NHS currently spending £411 million a year on antiretroviral drugs alone and the number of patients expected to keep on growing, there is a particular need to control this spending. Generic versions of efavirenz, lamivudine, ritonavir, zidovudine and nevirapine are already available in the UK. Within the next three years, tenofovir, abacavir, lopinavir, atazanavir and darunavir will also come off patent.
However pharmaceutical companies often use a strategy known as ‘evergreening’ in order to extend the period of time in which they have patented products in the market. One form this can take is the development of fixed dose combinations and single tablet regimens.
For example, lamivudine (Epivir) was first produced in 1990. Although the patent on this expired in 2010, GlaxoSmithKline had by then produced a pill that combined lamivudine with zidovudine (Combivir) which remained under patent until 2013. They also combined lamivudine with abacavir in Kivexa, which they will have the exclusive right to manufacture until 2019. Furthermore, the company has recently launched a one-pill-a-day HIV treatment, Triumeq, which puts lamivudine, abacavir and dolutegravir into a single tablet regimen.
Another example of ‘evergreening’ is Gilead’s tenofovir alafenamide fumarate (TAF), an alternative formulation of tenofovir that is safer for the kidneys and bones. While TAF was discovered in 2001 it will probably only be launched a few months before the original drug’s patent expires in 2017.
The development of single tablet regimens may meet a demand from patients and clinicians for treatments that are more convenient and easier to take, but can the high price tags be justified by better patient outcomes?
Antiretroviral regimens made up of generic drugs in three separate tablets typically cost less than £1000 per person per year. Branded single tablet regimens cost between £4500 and £7400 per person per year.
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