Research Roundup: Coronavirus vaccine trial starts, second patient cured of HIV, and new collaboration fills data gap on use of antimalarials in pregnancy

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Due to overwhelming demand, Gilead Sciences has paused granting patients access to remdesivir, an experimental drug which up until now has been used under a “compassionate use” policy against COVID-19—the disease caused by the novel coronavirus. In a statement, the company said it is focused on processing previously approved requests and establishing a new system that allows patients to get the drug in a similar time frame to what it would have taken to work through the requests it has already received. The company will make exceptions for pregnant women and children under the age of 18, as well as those with confirmed cases of COVID-19 who are experiencing “severe manifestations” of the disease. Gilead noted that, in recent weeks, there has been an “exponential increase” in requests for compassionate use of remdesivir due to the spread of COVID-19 in the United States and Europe, which has flooded the treatment access system which was never intended for use in response to a pandemic. Remdesivir is currently being studied in five large clinical trials, two of which could yield results in early April. The World Health Organization (WHO) has announced it will launch a multi-arm, multi-country clinical trial, known as the SOLIDARITY trial, for potential coronavirus therapies. The trial will test four drugs or drug combinations already licensed and used for other illnesses as part of a global effort to identify treatments for COVID-19. The four therapies include the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and the antimalarial drug chloroquine—all of which have shown some effectiveness against the novel coronavirus either in vitro and/or animal studies. These therapies will be compared to the standard of care—the regular support hospitals treating patients currently use, such as supplementary oxygen. Ten countries have already indicated they will take part in the trial. WHO launched a similar trial in the Democratic Republic of Congo in November 2018 to test four therapies against Ebola. Phase 2 and 3 clinical trials of Takeda’s tetravalent dengue vaccine candidate showed that it is safe, produces immunity in children, and protects against the disease—regardless of previous exposure to different strains of the virus—according to studies published in The Lancet. In the phase 3 trial, researchers found an overall vaccine effectiveness of 80.2 percent in the first 11 months and 73.3 percent in the first 17 months. Takeda’s dengue vaccine candidate is only the second dengue vaccine to enter clinical trials, following Sanofi Pasteur's Dengvaxia. Sanofi’s vaccine was 56–61 percent effective in preventing dengue in children, but it was tied to severe illness in some individuals vaccinated without having prior exposure to infection. Dengvaxia was approved by the US Food and Drug Administration last May, but with caveats due to potential adverse effects. Takeda is conducting clinical trials in dengue endemic countries before seeking regulatory approval.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.  The new all-oral drug combination of bedaquiline, pretomanid, and linezolid cures 90 percent of people with deadly drug-resistant tuberculosis (TB) if given for six months, according to clinical trial results reported in the New England Journal of Medicine (NEJM).Typically, this high of a success rate is only seen when TB responds to conventional therapy. When TB is resistant, the success rate falls to well below 50 percent and averages just 14 percent in South Africa, where the trial was conducted by TB Alliance. Current therapy for drug-resistant TB requires taking up to seven drugs, which cause many side effects, for at least 18 months. The new regimen takes just six months, has fewer side effects, and is less costly. TB kills an estimated 1.5 million people annually and of the 10 million new cases each year, roughly 500,000 are drug resistant. The Bill and Melinda Gates Foundation have paid for 15,000 drug molecules to be shipped to the Rega Institute for Medical Research, outside of Brussels, to be tested as a potential cure to the novel coronavirus. The samples are all active ingredients in current antiviral treatments which will be rapidly screened to determine whether they have an inhibiting effect on a sample from the first Belgian patient to be diagnosed. They expect to complete the screening in a week or two. The Gates Foundation has said it will provide up to US$100 million to improve detection, isolation, and treatment efforts in response to the coronavirus outbreak. Though there are currently no proven treatments for coronavirus, a few drug trials are already underway. As of last Wednesday, more than 93,000 people had been infected in more than 80 countries and the global death toll was 3,190. Results from two phase 3 clinical trials reported in the NEJM suggest that a monthly shot of the antiretroviral (ART) drugs cabotegravir and rilpivirine work just as well as daily pills to suppress the viral load of HIV in the bloodstream. ART therapy can effectively halt the replication of the virus and nearly eliminate it from the bloodstream, prolonging life expectancy. If approved by regulators, this long-acting combination therapy could be a more convenient treatment for people living with HIV than the conventional treatment regimen of two or more pills per day, which experts say can pose adherence challenges for many. There is currently no cure for HIV, the virus that causes AIDS.