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.

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The report contains the following:

• Volume and structure of procurements of ARV drugs in 2018
• Procurement structure of ARV drugs by expenses
• Cost of ARV drugs in 2018
• Cost of the most common treatment regimens
• Number of patients on ART, treatment coverage
• Conclusions and recommendations

The report in English is available here:

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The post The Analysis of Procurement of ARV Drugs in the Russian Federation in 2018 first appeared on ITPCru.

The findings and recommendations were used as a basis for discussions with stakeholders with the aime to optimize treatment regimens and increase treatment coverage. The original version in Russian can be found here. In 2019, a second report will be published, covering the situation with HIV and HCV drug procurement and provision in EECA in 2018.

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The post On the way to 90: Analysis of procurement and provision of ARV drugs in seven countries of Eastern Europe and Central Asia first appeared on ITPCru.

Based on the available information, including messages left on the website pereboi.kz, AIDS clinics either refuse to provide some antiretroviral drugs, or change HIV treatment regimens due to lack of medicines.

Civil society organizations report that the problem lies in the way the procurement and provision of antiretroviral drugs has been organized, including procurement via international agencies. This situation puts at risk the health of people living with HIV in the Republic of Kazakhstan, undermines the efforts to stop the epidemic and discredits the idea of optimizing procurement process and reducing prices using the opportunities provided by international procurement mechanisms.

We urge all the stakeholders, including the Ministry of Health of the Republic of Kazakhstan, SK-Pharmatsia, UNICEF, UNDP, UNAIDS, WHO, pharmaceutical companies, and community organizations to take all the necessary measures to solve the problem; if required, the option of urgent supplies of drugs as humanitarian aid shall be utilized. ITPCru is ready to provide informational or technical support should it be needed.

The post ITPCru’s statement on ARV stock-outs in Kazakhstan first appeared on ITPCru.

There are the following chapters in the report:

• ARVs procurement in Russia
• The list of the essential medicines
• The scope and structure of ARVs procured in 2017
• The procurement structure by the class and type of the medicine
• The cost of ARVs in 2017
• The number of patients on ART
• The cost of the most common treatment regimens

The report is available here:

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The post Coverage expansion: risks and opportunities. The findings of the ARV drugs procurement monitoring in 2017 first appeared on ITPCru.

The publication in English is available here:

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The poster is developed by ITPCru, it is available here in English:

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In Turkish:

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The post Good news for people with HIV poster first appeared on ITPCru.

The results of the study show that only 22% of people living with HIV have 95% and higher adherence. With this level of adherence, in fact, the treatment-as-prevention principle doesn’t work, and urgent measures have to be undertaken to improve the situation.

The assessment was performed by “Partners Network Association” with technical support of ITPC.

Full report (translation into English) is available here:

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The post Kyrgyzstan: Assessing Barriers for HIV/AIDS Treatment Coverage Expansion first appeared on ITPCru.

The purpose of the report is to obtain conclusions based on the analysis of 4500 public procurement monitoring data for ARV drugs in 2016, and to develop recommendations for improving the situation with drug provision in the Russian Federation.

We analyzed the following parameters:

• Minimum and maximum cost of the drugs (price dispersion among the regions);
• Weighted average cost of the drugs;
• Proportion of the drugs (based on one year treatment course and expences) in the total volume of purchases, by INN and trade names (TN);
• The timing of the announcement of auctions;
• The percentage of failed and canceled auctions from the total number of auctions included in the sample;
• The connection between the failure of auctions and the delivery of drugs;
• Distributors which win auctions in the constituent entities of the Russian Federation;
• The presence of competition in the auction;
• The amount of money for purchasing ARV drugs;
• Proportion of generic/original drugs in procurement;
• Number of one year treatment courses for drugs of various groups;
• Proportion of drugs included/not included in the VED list.

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Full version of the report in Russian language

The post Exit from the labyrinth: the end of decentralization. The results of monitoring of purchases of ARV drugs in Russia in 2016 first appeared on ITPCru.

The material can be downloaded from the following link:

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