September 3, twenty-five patient organizations working in the field of HIV response in Russia published an open letter to Gilead Sciences, asking the pharmaceutical company to disclaim patent rights for the combination of tenofovir and emtricitabine, marketed under the tradename Truvada.
Before that, Humanitarian Action Charitable Foundation, a St. Petersburg-based NGO, with the technical support of Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru), filed an opposition against a patent for this drug. The next hearing in the Chamber for Patent Disputes is scheduled for September 9, 2020.
The combination of tenofovir and emtricitabine is part of the key recommended regimen for initiating antiretroviral therapy according to the World Health Organization and the Russian Association of Specialists in HIV Prevention, Diagnostics and Treatment. Currently, it is the only regimen approved in Russia for pre-exposure prophylaxis (PreP).
It is important to note that Gilead Sciences on several occasions have made it clear that the company has no plans to actively market Truvada in Russia, and that the company’s strategy would focus on the novel drugs instead.
The drug is not included in the Essential Medicines List (EML), and during one of the meetings with patient organizations the company stated explicitly that it was not planning to re-submit the dossier for inclusion of TDF/FTC into the EML. Due to the absence of TDF/FTC in the EML, the price of TDF/FTC in Russia is not regulated. The current price in the range of USD200 per month places the drug out of reach for most patients either as HIV pre-exposure prophylaxis (PreP) or as treatment. In 2019, only 10 people could access it as part of the antiretroviral therapy within the government HIV treatment programme in Russia.
PreP is not yet covered and provided by the government, and patients must purchase the drug themselves. According to a study about PreP carried out by one of the Russian patient organizations (Phoenix-PLUS), only 6% of the respondents are willing and able to buy the original version of TDF/FTC at approximately USD200 per month.
There are currently several generic versions of TDF/FTC registered in Russia, which could be marketed at considerably lower prices if there were no patent protection (registration in itself is not a patent violation). The global prices for generic TDF/FTC can be as low as 3 USD per month; in some countries of EU, the price of generic TDF/FTC is below 50 EUR. In the Netherlands, for example, the price of TDF/FTC has dropped from 344.28 Euro (Gilead’s Truvada) for a 30 day supply to 47.95 Euro for the generic version.
The activists believe that availability of generic versions of tenofovir and emtricitabine in Russia will enable to significantly decrease the costs of PreP and expand its availability, as well as improve access to recommended fixed-dose combinations of antiretroviral drugs. This, in its turn, will increase the effectiveness of therapy and the HIV response.