Since the formal recognition of the human immunodeficiency virus (HIV) in 1981 in the United States, there have been ongoing research efforts to both better understand the cause of HIV and to develop effective antiretroviral drugs to target the virus. The introduction of a new antiretroviral agent into the therapeutic landscape of the HIV drug market has brought both optimism toward meeting this goal and conflict among two competing pharmaceutical companies.
It is well known that an HIV regimen can consist of a number of drugs that are taken simultaneously in an effort to suppress the symptoms of the virus. However, the Food and Drug Administration (FDA) recently approved a new once-a-day pill that contains bictegravir, emtricitabine and tenofovir to treat HIV. Specifically, what sets this new regimen apart from other treatments on the market is that it contains a novel, unboosted integrase strand transfer inhibitor (INSTI) — bictegravir.
This not only helps to reduce the pill burden that many patients have become used to with their antiretroviral regimens, but also serve to reduce the adverse effects that many patients can experience with multidrug antiretroviral regimens.
"Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients," said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.
The reported $22 billion HIV drug market could experience some dramatic effects as a result of this approval because of a rival integrase inhibitor that was on the market prior to the approval of the combination that contains bictegravir.
The pharmaceutical firm GlaxoSmithKline indicated that its subsidiary ViiV filed a patent infringement proceeding against Gilead Sciences, the manufacturer of the bictegravir pill, arguing that the drug violated the intellectual property that was held by ViiV for its integrase inhibitor, dolutegravir. Dolutegravir is recognized as a key element in the most recent HIV product that ViiV launched in a three-drug regimen called Juluca.
The introduction of litigation against Gilead may impact the availability of this new regimen until a decision has been made by a court of law. The desired goal of the release of any new drug is to provide new therapeutic options for patients and potentially a better way to treat an existing condition or disease.
While it is still to be determined if the approval of the once-daily pill containing bictregravir will surpass other drugs in the market to treat HIV, it is one that individuals with HIV should be able to have access to and not be restricted by the current legal battle.
