April 17, 2020
With more than hundreds of thousands of confirmed cases, the coronavirus (SARS-COV-2) continues spreading across the globe at an alarming rate. In an effort to find a solution to the COVID-19 pandemic, researchers are considering a number of existing medications in pursuit in finding both an effective treatment, as well as a prevention protocol.
In their race to find a solution to this global pandemic, a number of clinical trials have begun recruiting patients and conducting studies using drugs that are already established as a treatment for other illnesses. The medications considered are drugs meant to treat HIV, Ebola and Malaria.
One of the therapies researchers have begun clinical trials on is a drug combination used in the treatment and prevention of HIV. PrEP (emtricitabine/tenofovir) is sold under the brand names Truvada and Descovy and is manufactured by Gilead Sciences.
In late March, the vice president for public affairs at Gilead Sciences, Sonia Choi, said the company planned to test the use of PrEP against the novel coronavirus in an email response to a Washington Blade inquiry on the use of the medication against COVID-19.
Although, Choi said the biotechnology company does not have high expectations that the drug will be effective due to its ineffectiveness against other diseases.
“We are planning to assess the in vitro antiviral activity of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), the components of Truvada, against coronaviruses,” Choi said. “However, based on in vitro testing against other RNA viruses including Ebola virus, hepatitis C virus, respiratory syncytial virus, and bovine viral diarrhea virus, we do not expect to observe the antiviral activity of TDF or FTC against coronaviruses.”
In addition to the clinical trials testing PrEP’s effectiveness to treat COVID-19, a new clinical trial being conducted at Ramon y Cajal University in Spain that began on April 1, will be determining if the drug can be used to prevent the infection of the disease, particularly in healthcare workers who are treating infected patients.
In an email to the Washington Blade, research director of HIV and infectious diseases at La Paz Hospital in Madrid, Spain, Dr. Jose Arribas, said one reason why they decided to pursue clinical trials testing PrEP’s effectiveness in preventing COVID-19 infection is the fact that there have been HIV patients who are on the medication that have tested positive for the disease.
“We are seeing few cases of HIV-positive people with severe COVID-19,” Arribas said. “This is surprising because the immune system of an HIV-positive person has similarities to that of older people who do have severe cases of COVID-19. Furthermore, there is evidence from in vitro studies support that Truvada can have an immunomodulatory effect.”
The clinical trial will be facilitated over the course of 12 weeks and will consist of participants of the trial being administered daily doses of tenofovir, disopoxil, fumarate and emtricitabine (the components of PrEP) and hydroxychloroquine, as well as placebos.
The participants of the trial will be divided into three groups with each group receiving a different combination of placebo and PrEP components, first assessing the number of COVID-19 infections followed by assessing the severity of each infection based on different criteria.
In a report posted on their website (clinicaltrials.gov) on April 9, The National Institutes of Health in the United States, who provide updates on existing clinical trials as well as emerging ones around the globe, said they will be assessing both PrEP’s effectiveness to treat and prevent COVID-19 and anticipate the study’s initial results to be made available no earlier than July 31.