You may be wondering how generics can be cheaper when they are identical to the branded drug. Here’s why.
The medication used as PrEP is patented, which means that only one company, Gilead, is legally allowed to produce and sell emtricitabine/tenofovir in USA, Canada, the UK, Australia, EU, and other developed countries. As Gilead has no competition, they can charge whatever price they feel the market will bear.
Developing countries, such as those in sub-Saharan Africa, India, Pakistan, Thailand, etc. clearly cannot afford to pay $1600/month for essential anti-HIV medications. Companies like Gilead have, fortunately, agreed to not enforce their patents in these countries. This allows the production and distribution of generic versions of their drugs in resource-poor settings. As a result, over two-thirds of the world’s anti-HIV medications are now produced in India. Other major producers of generics include South Africa, Thailand and Brazil.
By purchasing this medication from a country where it is legally produced and distributed in generic form, PrEPGeneric customers are circumventing one company’s monopoly and price tag which is unaffordable for the vast majority of individuals and, arguably, the healthcare system itself.
There are reports of clinics in London, UK, who have used therapeutic drug monitoring (TDM) to confirm that the drugs are in present (and in effective/safe amounts) in the blood of people who are taking generic PrEP which was ordered online. There have been no reports available to-date of TDM revealing counterfeit or faulty generic PrEP. The use of TDM for this purpose in BC is currently being done as a part of a research study **see 11-Jun-2017 update below**
UPDATE 03-Sep-2016: The HIV/MSM clinic 56 Dean Street in London, England, has published a summary of results of TDM on 162 blood samples by patients on generic PrEP (including Ricovir-EM). They reported zero counterfeits. Click here to read the summary.
UPDATE 26-Oct-2016: At the International Conference on HIV Drug Therapy in Glasgow, a researcher from 56 Dean Street presented data showing adequate blood levels of drug among 234 patients who purchased generic PrEP online. Though this did include Mylan’s Ricovir-EM, most samples were of Cipla’s Tenvir-EM.
UPDATE 07-Nov-2016: There are reports of half a dozen Vancouverites taking Ricovir-EM who have had TDM through St. Paul’s Hospital — all with good results. There is no official channel through which generic PrEP users can access TDM yet, but talks are underway. Ask your doctor (and stay tuned!)
UPDATE 26-Mar-2017: We've posted the batch certification supplied by Mylan for for the current lot of generic emtricitabine/tenofovir being distributed (lot 3061516, exp Nov-2019). You can view it here: Page 1 and Page 2
UPDATE 22-Apr-2017: 56 Dean Street presented this poster at the British HIV Association conference, showing TDM data on 277 patients using generic PrEP.
UPDATE 11-Jun-2017: a research study measuring drug levels of generic PrEP has launched in Vancouver. Click here to learn more.