The Institute of Technology in Pharmaceuticals (Farmanguinhos / Fiocruz) obtained the registration of the generic Dolutegravir (DTG) sodium clone. The antiretroviral drug was submitted to the National Health Surveillance Agency (Anvisa) in August 2020 and approval was given by Resolution No. 3972, published (5/10) in the Federal Official Gazette. The drug will be the result of a technology transfer, signed in July 2020, with the pharmaceutical companies ViiV Healthcare and GSK. Called Strategic Alliance, the cooperation includes the technology transfer and the supply of the drugs Dolutegravir 50mg, Lamivudine 300mg, and Dolutegravir 50 mg + Lamivudine 300mg.

The largest public producer of antiretroviral drugs, Farmanguinhos / Fiocruz works to expand the population's access to treatment. In addition to the internalization of technology, the Foundation's unit will achieve lower costs with internal production and ensure greater technological autonomy for the country, from the acquisition of this new methodology without depending on the import of antiretroviral drug.

Farmanguinhos / Fiocruz director, Jorge Mendonça emphasizes the importance of the partnership for the country. “Throughout its history, Farmanguinhos has produced important antiretroviral drugs for the Brazilian Unified Health System. Internalizing the technology of such an effective drug for HIV / AIDS treatment, means expanding the population's access and valuing the Brazilian pharmaceutical industry, since we have also nationalized the active ingredient technology", he explains.

Technology transfer

The technology transfer was divided into four phases. The first one includes the adequacy of the manufacturing plant to the characteristics of Quality, transfer of Dolutegravir Analytical Methodology and Technical Assistance for the production of Lamivudine 300mg.

The next stage is scheduled for January 2021, and covers the technology transfer for manufacturing and packaging of the drug, Quality Control analyses, among others. In the final stages, transfers of other methodologies and analyses, and post-registration of the inclusion of the manufacturing site and Quality Control. The forecast is that all the technology will be completed by 2025.

At the end of the absorption transfer, Farmanguinhos will have added a new technological platform for the production of tablets in double layer, besides having acquired the necessary technical knowledge for the manufacture, packaging, and distribution of strategic drugs for the Ministry of Health.

HIV / Aids treatment

Since 2017, Dolutegravir has been included in the Ministry of Health's protocol for HIV / AIDS treatment. Patients who had not yet started treatment with other antiretroviral drugs, or had resistance to previous drugs, benefited from dolutegravir, which was later included in the clinical protocols and therapeutic guidelines for HIV.

The drug was the subject of a Brazilian study, carried out in 2018 with more than 100,000 patients beginning antiretroviral therapy. It demonstrated greater effectiveness in AIDS treatment when compared to other antiretroviral drugs.

Antiretroviral therapy significantly decreases the viral load in the blood, suppressing undetectable levels. Achieving and maintaining an undetectable viral load, in addition to bringing numerous health benefits to people living with HIV, reduces the risk of sexual transmission of the virus to almost zero. Therefore, the trial results are even more encouraging for the Brazilian response to HIV.