Editor’s note: To be clear, there is no scientifically proven evidence that Truvada or other HIV meds successfully treat or prevent COVID-19. The clinical trial discussed below hopes to assess Truvada’s potential as prevention.
Can health care workers take HIV med Truvada to prevent them from getting COVID-19? What about the anti-malaria drug hydroxychloroquine? A new clinical trial in Spain, which began April 1, aims to find out. Initial results of the 12-week study are expected June 30; final results arrive July 31.
Truvada, which consists of two meds—tenofovir disoproxil fumarate and emtricitabine—has long been a part of treatment regimens for people living with HIV. It is also highly effective when used by HIV-negative people as pre-exposure prophylaxis, or PrEP, to prevent contracting HIV.
So why test Truvada as a COVID-19 prophylaxis? “We are seeing few cases of HIV-positive people with severe COVID-19,” Jose Arribas, MD, research director of HIV and infectious diseases at La Paz Hospital in Madrid, tells The Washington Blade. “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…that Truvada can have an immunomodulatory effect,” meaning that it may affect the immune system’s activity and thus lower its inflammatory response.
Researchers therefore want to assess Truvada’s potential to protect health care workers, a population at higher risk of contracting COVID-19, the potentially lethal respiratory disease caused by the new coronavirus.
The U.S. National Institutes of Health posted a description of the study on ClinicalTrials.gov, but the U.S. government is neither conducting or funding it.
In total, the study will enroll 4,000 participants randomized into four groups taking one of the following single-dose daily regimens:
- Truvada + a placebo of hydroxychloroquine
- Hydroxychloroquine + a placebo of Truvada
- Truvada + hydroxychloroquine
- A placebo of Truvada + a placebo of hydroxychloroquine.
Once the study is complete, researchers will assess whether any of the four regimens lowered the number of symptomatic COVID-19 cases or reduced the severity of the disease.
Researchers can then evaluate whether the meds could be used by the general population, Arribas told the Blade.
The study is led by Plan Nacional sobre el Sida, the Spanish National AIDS Plan.
In related news, keep in mind that novel coronavirus guidance and concerns for unique populations may vary. For example, see “How Many People With HIV Are Getting COVID-19?,” “3 Reasons COVID-19 Poses a Higher Risk for the LGBTQ Population,” “UPDATED: What People With HIV Need to Know About the New Coronavirus” and the similar article for people with cancer.
Go to poz.com/tag/coronavirus for our continuing coverage of COVID-19.
Updated editor’s note April 20: It has come to our attention that the researchers in Spain may be using generic versions of Truvada instead of the tablet manufactured by Gilead Sciences.