We are surprised by the position of the Ministry of Health in relation to the efficacy and safety of the drug Rendesivir, recently approved by Anvisa and in more than 50 countries worldwide.

We have had continuous dialogue with the Ministry to define the best use of Rendesivir. During the product registration process, we kept in constant contact to keep them informed about the evolution of the studies and the data on the use of the product in real life.

We emphasize that Rendesivir is the only approved antiviral treatment and indicated on the label for the treatment of Covid-19 and important therapy in the viremic phase of the disease, that is, in the early stages. However, the drug is still not approved for CMED price for commercialization in Brazil.

We would like to point out that the best use of the product is when the patient is hospitalized, with pneumonia by SARS – CoV 2 using low or high flow oxygen and not when the patients are intubated and under mechanical ventilation. One of the benefits of Rendesivir is that it reduces the length of hospital stay and, therefore, the release of beds for patients to be welcomed in the already saturated hospital environment.

The ACTT 1 study demonstrated that patients randomized to the Rendesivir arm had a shorter recovery time than patients on the placebo arm, in addition to reducing progression to more severe forms. Also according to FDA approval: in the general patient population, there was a 27% reduction in mortality with Rendesivir compared to placebo on Day 29 (11.4% vs. 15.2%, HR 0, 73; 95% CI, 0.52 to 1.03). Additional mortality data from a post-hoc analysis was published in the New England Journal of Medicine on October 8, 2020.

With this, we believe that, in the current scenario in which we live with the health system operating at maximum capacity, the use of Rendesivir is essential.

Finally, Gilead is committed to accessing drugs that can save lives and reiterates its commitment to the country at this very important time.

São Paulo, April 1, 2021.

Cordially,

GILEAD SCIENCES FARMACÊUTICA DO BRASIL LTDA.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical dedicated to the research, development and commercialization of innovative therapies for the prevention, treatment and cure of potentially fatal diseases, such as HIV / AIDS, viral hepatitis, among others. Gilead was responsible for great achievements for health and quality of life by offering the first single-pill antiretroviral regimen for the treatment of HIV / AIDS, in addition to revolutionizing the treatment of hepatitis C with the first drug that presented the possibility of cure of the disease. Present in Brazil since 2013 with headquarters in São Paulo, Gilead has operations in more than 35 countries, with headquarters in Foster City, California, in the United States.