Yesterday the BBC issued a misleading news report on the efficacy of generic antiretroviral drugs (ARVs) suggesting that generic ARVs are less efficacious than branded alternatives. The report, based upon a study led by Massachusetts General Hospital (MGH) and Weill Cornell Medical College investigators, fails to separate the issues of ‘treatment efficacy’ and ‘adherence’ leading to distorted and alarmist conclusions.
The current recommended treatment for newly diagnosed patients in the US is Atripla, a fixed dose combination (FDC) made up of three branded drugs; tenofovir disoproxil fumarate ,emtricitabine and efavirenz. Last year a generic form of the antiretroviral drug lamivudine became available on the US market (which shares the same molecular structure as FTC and can thus be substituted in a combination treatment regimen) and a generic version of Efavirenz is expected in the relatively near future.
The entry of these generic equivalents mean that instead of issuing Atripla as an FDC, doctors could put patients on a 3-pill a day regimen including the two generic versions and branded tenofovir disoproxil fumarate, an option that could save $1 billion for the US who last year spent $9 billion procuring antiretroviral drugs. Generic drugs are much cheaper than their monopolised branded equivalents, as widespread competition amongst generic manufacturers pushes prices down.
The quoted study used modelling to compare the branded Atripla regimen with a combination of generic efavirenz and lamivudine with brand tenofovir disoproxil fumarate. However, the study did not compare like with like and has been misinterpreted.
The reporting of the study confuses adherence to treatment with drug efficacy. From a clinical perspective FDCs have advantages over separate pills. Logically it is easier to take one pill a day, than three pills a day, thus people adhere better to their treatment regimens when their ‘pill burden’ is lighter. Adherence is important as missing pills, or taking them at the wrong time can lead to drug resistance and ultimately treatment failure. However, missing a pill does not mean that the actual drug is not efficacious but rather that the patient finds it harder to take three pills than to take one.
What the study and the reporting of it fail to mention is that quality assured generic FDCs of Atripla are currently available on the global market- generic Atripla is manufactured by several generic companies and the lowest cost for a quality assured1 FDC available in developing countries is currently only US$ 197 per patient per year2- less than 1% of the price paid for the branded product in the US. The issue is just that these medicines are not available in the US due to decisions of the US government. Generic companies have led the way in producing FDCs for developing countries, whilst people in wealthy countries had to continue to take multiple pills due to restrictive patent systems.
The issue in question is not around whether generic drugs are less effective, which is an incorrect assumption based on a misreading of the study. It is rather whether restrictive and anti-competitive patenting activity carried out by the pharmaceutical industry to protect their profit should be allowed to block effective and less expensive FDCs from being available to people living with HIV. Without constant patent ever-greening (modifying existing drugs in order to lengthen patent terms) an effective generic version of Atripla would be available in the US, like it is in developing countries. The real question is whether people should suffer in order to allow greater profits for the pharmaceutical industry.
1 Products quality assured by US FDA and WHO prequalification.
2 For a list of generic FDCs of TDF/FTC/EFV please see, Médecins Sans Frontières, ‘Untangling the Web of Antiretroviral Price Reductions’, (October, 2012), http://utw.msfaccess.org/drugs/4fe29ea5850dfc2ba800001f