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ViiV's Tivicay suppresses HIV in patients who also have tuberculosis

ViiV Healthcare Ltd.'s Tivicay, in combination with a class of antiretroviral drugs, showed high levels of viral suppression in a phase 3b study of certain HIV patients who also had tuberculosis.

The study, called Inspiring, enrolled 113 adults with HIV who had not received antiretroviral treatment and also had tuberculosis, or TB, an infectious disease that usually affects the lungs. The patients received TB treatment for eight weeks in the form of the antibiotic rifampin.

Antiretroviral drugs are medications that do not kill or cure the HIV virus but can slow down or prevent the growth of the virus.

The results were presented at the 2018 Conference on Retroviruses and Opportunistic Infections in Boston.

Tivicay, also known as dolutegravir, is being rolled out widely in areas where tuberculosis incidence is high, so researchers felt it would be important to test the medicine in populations co-infected with HIV and TB, Kelly Dooley, an infectious diseases researcher at Johns Hopkins University, said on the sidelines of the conference.

"It's very important primarily in areas of the world where there are very few other alternatives for treatment of TB and HIV, to understand how dolutegravir fits with the treatment paradigms in those areas, particularly as most of the countries with the highest burden don't have dolutegravir access and they will very soon," said Constance Benson, researcher at the University of California San Diego and the chair of the press conference.

Of the enrolled participants in the trial, 69 patients received Tivicay along with two nucleoside reverse transcriptase inhibitors, or NRTIs, a type of antiretroviral drug. The remaining 44 patients received Bristol-Myers Squibb Co.'s Sustiva, or efavirenz, with two NRTIs.

An interim analysis conducted at 24 weeks into the study showed that 56 patients, or 81% of the patients on Tivicay, maintained viral suppression. Viral suppression is reached when the level of HIV in the blood is very low and undetectable, but it does not mean that the patient is cured.

In the Sustiva group, 39 patients, or 89%, maintained viral suppression at 24 weeks.

"I certainly would feel comfortable using the dolutegravir regimen that was done in this trial. In fact, many of us already are using it," Benson stated.

No patients in the Tivicay group and two patients in the Sustiva group discontinued the treatment due to side effects. However, five patients in the Tivicay group discontinued the therapy due to reasons not related to treatment.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline PLC, and Pfizer Inc. GSK holds a majority stake in the company. Japan-based Shionogi & Co. Ltd. is also a shareholder in ViiV Healthcare.