Drugs

New HIV Drug, Tivicay, Approved By FDA, Deemed Slightly Better Than Atripla

GlaxoSmithKline
A new HIV drug made by GLaxoSmithKline, Tivicay, has gained approval by the FDA approval to treat HIV infection. GSK

The U.S. Food and Drug Administration (FDA) has approved a new drug from GlaxoSmithKline, Tivicay, for the treatment of individuals with HIV infection. The drug was given a "Fast Track" approval designation in February because it showed promise at being better than current treatments on the market.

Tivicay — or as it is technically called, Dolutegravir — is an integrase inhibitor which prevents the HIV virus from initially infecting its target cell type, CD4 cells. The drug is designed to be combined with other drugs currently on the market, abacavir (Ziagen) and lamivudine (Zeffix). The drug is designed for those patients for which other integrase inhibitors do not work because their HIV infection had or is resistant.

HIV infection lays waste to the immune system and decimates the CD4 T-cell population of the immune system. Patients who are not treated with anti-retroviral drugs will progress to AIDS, a syndrome in which their immune system does not function properly and they are susceptible to opportunistic infections that people with a healthy immune system would easily fend off.

One of the reasons HIV is so hard to treat is because the virus mutates more quickly than normal. This is due to a number of reasons, including some patients not taking their medication and others not knowing they are infected. As a result, there needs to be a steady stream of new drugs to counter the fast-evolving virus.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

The clinical trials that proved to the FDA that the drug was an improvement over currently available treatment was a study which showed that the drug brought down viral load to undetectable levels in 88 percent of patients compared to 81 percent for patients treated with Atripla after four months of treatment. The clinical trials consisted of four studies and 2,539 participants.

For patients whose medication works at making their viral load undetectable are advised to not switch medications unless their medication stops working. Patients with HIV infection must remain on medication their entire lives to prevent the virus from becoming activated once more and killing of the remaining CD4 T-cells that they have remaining.

About 50,000 Americans are infected with HIV every year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention. Most people who died of the disease did not know that they were infected and were not on proper treatment to keep their immune system healthy and viral loads low. By being treated with medications, patients signifigantly reduce and close to eliminate, their risk of transmitting their infection to others in addition to keeping themselves healthy. 

The drug is approved for patients 12 years and older who are at least 88 lbs and have not previously been on an integrase inhibitor drug, and those that have been treated with other drugs. 

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