For the first time, a two-drug HIV treatment regimen was been given the US FDA’s seal of approval on Tuesday.
The therapy, called Juluca, is one of a growing number of treatment options designed to reduce the number of drugs – and therefore side effects – that people living with HIV need to take in order to suppress the virus.
Juluca is a fixed-dose tablet that combines two previously approved drugs, and is available to patients who have been on another stable treatment regimen for at least six months.
The therapy is the first out of three rival two-drug treatments to receive FDA approval after successful clinical trials.
The FDA has approved a new two-drug HIV therapy. Juluca combines two previously approved drugs to maintain undetectable viral loads in people with HIVwho have been on consistent standard treatments
Juluca uses dolutegravir and rilpivirine to prevent the HIV virus from making copies of itself.
Both ingredients have been previously approved by the FDA, but studies on Juluca found that patients who switched to the two-drug regimen from their previous ones were able to maintain an undetectable viral load after the change, even without a third antiretroviral drug in the cocktail.
The standard of treatment for people with HIV is one of a number of antiretroviral therapies that combine three drugs.
These treatments have been astonishingly successful in extending and improving the quality of the lives of people who are HIV positive.
Recently, the CDC declared that those on a consistent treatment could reduce their viral loads – the number of copies of the HIV virus in their blood – to such a low level that the disease can be considered non-transmissible.
Yet, standard treatments require strict and sometimes complicated dosage regimens, and can cause unpleasant day-to-day side effects like nausea, weakness and insomnia, as well as long-term damage to the liver and kidneys and heart.
The benefits of these treatments outweigh their risks, but the side effects have inspired a push for innovative therapies like Juluca.
Standard therapies like Truvada have to be taken daily and at exactly the same times. Failure to do so can drastically weaken the immune system and increase the risk of transmitting the HIV virus.
Many researchers are looking to gene and other therapies that might involve a less rigid regimen. Alternatives might include therapies that are injectable or, like Juluca, involve fewer active drugs.
Some patients are already involved in trials for Charlie Sheen, for example, started on a drug called PRO-140 as part of a clinical trial in 2016, and claimed that the weekly injection had kept his virus at undetectable levels.
Like many HIV treatments in trial, PRO-140 only works to suppress certain strains of the virus.
Juluca’s approval puts it ahead of rival Gilead Sciences in the race to market with two-drug combinations for HIV treatments, although uptake could be slow because rilpivirine has the downside that it must be taken with a meal at the same time every day.
Juluca belongs to GlaxoSmithKline Plc’s majority-owned ViiV Healthcare, in which Pfizer and Shionogi also have small stakes.
ViiV’s dolutegravir is part of GSK’s traditional triple-therapy used to control the AIDS virus.
The FDA has a February deadline to decide on Gilead’s competing combination.
GSK is also working on a second two-drug combination that will replace rilpivirine with a common off-patent drug called 3TC that could reach the market in the second half of 2019 if clinical trials are successful.