This 7% difference was statistically significant for superiority of the dolutegravir based regimens.

Common side effects of dolutegravir in clinical trials included insomnia and headache.

In 2014 this license was extended to include dolutegravir and adults with HIV.

Dolutegravir and abacavir were shown to be excreted in the milk of lactating rats.

As of early 2014, two other clinically approved integrase inhibitors are elvitegravir and dolutegravir.

It is an integrase inhibitor, with a carbamoyl pyridone structure similar to dolutegravir.

Abacavir and dolutegravir are both seen as priority products for fighting HIV in poor countries.

In February, 2013 the Food and Drug Administration announced that it would fast track dolutegravir's approval process.

Tivicay (dolutegravir)

"It's an affirmation of our belief in dolutegravir as a potential important medicine in HIV," he said in an interview.

The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.

Analysts see dolutegravir as a strong competitor to HIV treatments from market leader Gilead Sciences.

SPRING-2 compared dolutegravir to another integrase inhibitor, raltegravir.

In total, 88 percent of study participants on once-daily dolutegravir had their virus suppressed against 85 percent of those on twice-daily Isentress.

The once-daily drug, known generically as dolutegravir, belongs to a novel class known as integrase inhibitors that block the virus from entering cells.

In exchange, Shionogi will give Viiv the rights to its HIV/AIDS treatment dolutegravir.

The FLAMINGO study was an open-label trial of dolutegravir versus darunavir boosted with ritonavir.

Drug interactions was updated to include a statement that in vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3.

The result is the second positive final-stage Phase III clinical read-out for dolutegravir, following encouraging results against Merck & Co's rival Isentress in April.

After 48 weeks of treatment 88% of those on dolutegravir had less than 50 copies of HIV per mL compared to 85% in the raltegravir group, thus demonstrating non-inferiority.

Dolutegravir inhibits the HIV replication cycle by binding to the integrase active site and inhibiting the strand transfer step of HIV-1 DNA integration.

Dolutegravir, a once-daily drug that has performed strongly in clinical trials, is seen by analysts as a potential multibillion-dollar-a-year seller and a strong competitor to treatments from market leader Gilead Sciences.

Dolutegravir, brand name Tivicay, licensed by ViiV Healthcare, was approved by the FDA in 2013 and has recently gained European approval in January 2014.

David Redfern, GSK’s chief strategy officer, who chairs Viiv’s board, said the deal confirmed GSK’s belief in dolutegravir as a potentially important medicine in HIV.

It is also hoping for approval of the two lung drugs, Relvar and Anoro; an HIV medicine called dolutegravir; and two melanoma drugs dabrafenib and trametinib.