A new clinical trial is underway in Spain that will assess whether Truvada, a drug commonly used as PrEP for HIV prevention, can stave off COVID-19 infection among medical practitioners seeking to treat patients amid the pandemic.
If successful, the trial may have broader implications for the general public and not just health workers. But the next step would be awaiting the result of the trials before the drug is determined to be effective.
The study, which began April 1 and is expected to run through the summer, is being conducted at Ramón y Cajal University Hospital in Madrid and sponsored by the Spanish National AIDS Plan, an arm of the Spanish government.
An estimated 4,000 participants will participate in the study, each of whom are medical workers age 18 to 65 working in areas of Spain heavily afflicted with the coronavirus.
Dr. Jose Arribas, research director of HIV and infectious diseases at La Paz Hospital in Madrid, said in Spanish via email to the Washington Blade one underlying basis for testing Truvada against COVID-19 is his findings that relatively few HIV-positive people have 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.”
Asked whether Truvada could be used for everyone, not just health care workers, if shown to have a positive impact in the study, Arribas replied, “You have to wait for the results of the study before we can answer this question.”
The National Institutes of Health in the United States posted a notice Monday about the test on the agency’s website, which lists ongoing or upcoming clinical trials across the globe.
According to the abstract, the study will seek to assess whether the components of Truvada — as well as hydroxychloroquine, a drug with well publicized potential use against COVID-19 — are effective in preventing coronavirus infection among medical practitioners because “healthcare workers are particularly at risk of SARS-CoV-2.”
“In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specifically in healthcare workers is being sought,” the abstract says. “Administration of effective drugs to people at risk of developing an infectious disease is well accepted and is part of clinical practice.”
The choice of Truvada for the study, according to the abstract, is the result of anecdotal evidence the medicine may be effective against COVID-19.
“Existing recent and scarce literature shows that RNA synthesis nucleos(t)ide analogue inhibitors, acting as viral RNA chain terminators, like TDF, abacavir or lamivudine, amongst others, could have an effect against SARS-CoV-2 infection,” the abstract says.
Over the course of the 12-week study, administrators will provide daily doses of Tenofovir Disoproxil Fumarate and Emtricitabine, the components of Truvada, Hydroxychloroquine and placebos to study participants.
One group will receive a daily dose of Truvada and a hydroxychloroquine placebo; another will receive hydroxychloroquine and a Truvada placebo; another will receive both drugs; and another will receive a placebo of both drugs.
The trial will assess confirmed infections of COVID-19 as a primary outcome measure, then the severity of disease, including its duration, among confirmed infected participants as a secondary outcome measure.
The initial results of the study are expected to be compiled by June 30, but the study won’t be completed until July 31, the abstract says.
Overseeing the test will be Dr. Rosa Polo of the Spanish National AIDS Plan and Miguel Hernan, an epidemiologist at the Harvard School of Public Health, according to the abstract.
Ramón y Cajal University Hospital in Madrid and the Spanish National AIDS Plan didn’t respond to a request for comment.
Truvada has been brought up as a potential drug to test against COVID-19 among many other medications being assessed for use against the epidemic. Also in the mix is Remdesivir, an antiviral drug the medical experts have said may hold the best chance against COVID-19.
Dr. Sarah Henn, chief health officer of the D.C-based Whitman-Walker Health, welcomed news of the trial in an email responding to the Washington Blade’s request to comment on the study.
“We are happy to see trials focusing on both prevention and treatment of COVID-19 infections and look forward to learning from these results,” Henn said.
Dr. David Hardy, adjunct professor of medicine for the Division of Infectious Diseases at Johns Hopkins University School of Medicine, on expressed skepticism about study because it makes “a big jump” on the use of Truvada for HIV prevention to its use for COVID-19 prevention.
“Truvada for PrEP was created as a new option for trying to prevent
those who aren’t infected with HIV,” Hardy said. “If we can use that analogy with COVID-19, we don’t have a treatment that we can easily extrapolate into prevention yet.”
Based on that, Hardy said he’d be more supportive of a study that strictly tested hydroxychloroquine as a means to prevent COVID-19, and not the combination of the drug with Truvada.
“That’s simply because of the fact that we list up some laboratory information that says that hydroxychloroquine does in fact have some anti SARS-CoV-2 antiviral activity,” Hardy said. “We know that it works against the virus, at least in a test tube.”
Gilead Sciences, the manufacturer of Truvada, has told the Blade it would conduct an in vitro test of the components of Truvada against the coronavirus, but has low expectations for the drug’s effectiveness. The company hasn’t responded to requests from the Blade for an update.
The Spain study appears strictly to be a project of the Spanish government; U.S. government health officials aren’t involved even though NIH posted an abstract of the study online.
Kathy Stover, a spokesperson for the National Institutes of Health, told the Washington Blade NIH doesn’t have any involvement in the study.
“The study you highlighted is actually not being funded or conducted by the NIH,” Stover said. “It’s being led by the Plan Nacional sobre el Sida (PNS) in Spain.”