ANVISA clarifies that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine for the treatment of COVID-19.
Debated Scientific Evidence
In the context of the current pandemic resulting from the new Coronavirus, scientific evidence on the potential use of Chloroquine and Hydroxychloroquine in the treatment of disease are being generated and published.
An in vitro study developed by Chinese researchers evaluated the effect antiviral of hydroxychloroquine against SARS-CoV-2 compared to Chloroquine. The researchers affirm that Hydroxychloroquine has effectively inhibited the viruses in the cell as well as later cell stages related to infection by SARS-CoV-2. This effect was also observed with chloroquine.
Gautret et al. conducted a non-randomized open-label clinical trial. Although its small sample size (20 patients were treated), the authors affirm that this research shows that treatment with Hydroxychloroquine is significantly associated with the reduction / disappearance of the viral load in patients with COVID-19 and its effect is reinforced by Azithromycin.
According to systematic review, there is pre-clinical evidence of effectiveness and of safety of long-standing clinical use for other indications, which justifies the clinical research with Chloroquine in patients with COVID-19. The conclusion of this review was that safety data and higher quality clinical trial data are urgently needed.
According Anvisa the use of hydroxychloroquine and chloroquine for the treatment of Covid-19, Anvisa;
– these drugs are registered by the Agency for the treatment of arthritis, lupus erythematosus, photosensitive diseases and malaria;
– reinforces that for the inclusion of new therapeutic indications in medicines and that it is necessary to conduct clinical studies on a representative sample of human beings, demonstrating safety and effectiveness for the intended use;
-There is no recommendation from Anvisa, at the moment, for their use in infected patients or even as a way to prevent contamination by the new coronavirus
– warns citizens that self-medication may represent a serious risk to their health.
- Anvisa. Clarifications on hydroxychloroquine and chloroquine.
- Anivsa. Technical note.
- Gautret, P., Lagier, J. C., Parola, P., Meddeb, L., Mailhe, M., Doudier, B., … & Honoré, S. (2020). Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents, 105949.
- Liu, J., Cao, R., Xu, M. et al. Hydroxychloroquine, a less toxic derivative of
chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov 6, 16 (2020). https://doi.org/10.1038/s41421-020-0156-0
- Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J CritCare. 2020 Mar 10. pii: S0883 9441(20)30390-7. doi:10.1016/j.jcrc.2020.03.005. [Epubahead of print] PubMed PMID: 32173110.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.