ViiV Healthcare’s two-month injection proved to be as effective as monthly injections for HIV treatment that are currently on the market, the GlaxoSmithKline subsidiary said this morning as it continues to position itself for a leading share of the market alongside Gilead Sciences.
ViiV Healthcare’s two-month injection proved to be as effective as monthly injections for HIV treatment that are currently on the market, the GlaxoSmithKline subsidiary said this morning as it continues to position itself for a leading share of the market alongside Gilead Sciences.
U.K.-based ViiV, which is also supported by Pfizer and Shionogi Limited, said results from its Phase III ATLAS-2M study of its two-drug combination of cabotegravir and Janssen’s rilpivirine administered every eight weeks was non-inferior in treating the disease as the same two drugs administered monthly. In previous studies, the combination regimen in injection form has shown to be as effective as daily consumption of a three-pill regimen for HIV treatment. The results of this study indicate that the number of injections and HIV patient needs to maintain similar efficacy would only have to be administered every two months. ViiV did not provide full details of the ATLAS-2M study in its announcement. The company said it will provide detailed data at an upcoming scientific meeting.
Kimberly Smith, head of research and development at ViiV, said the data from the Phase III study is exciting news for HIV patients. Since the AIDS epidemic began more than three decades ago, Smith said the ATLAS-2M study demonstrated that it is possible to maintain suppression of the HIV virus with an injectable regimen containing two drugs administered every two months.
“This is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments. The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year. Approval of this regimen would mark a significant change in the HIV treatment paradigm,” Smith said in a statement.
The ATLAS results
Since its inception, ViiV has maintains an extensive focus on developing two-drug regimens for the treatment of HIV in order to boost efficacy, as well as benefit patient compliance. The announcement of the success of the ATLAS-2M study comes only a few weeks after ViiV announced another two-drug regimen, dolutegravir plus lamivudine, continued to provide the same level of efficacy as a three-drug cocktail of dolutegravir plus two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) with no cases of treatment emergent resistance in individuals with virologic behavior. The data from the Phase III GEMINI 1 & 2 studies showed the two-drug program was non-inferior through 96 weeks of study.
At the same time, the GEMINI data was revealed, ViiV also revealed results from the TANGO study that showed its approved two-drug combo, Dovato, (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally suppressed and stable adults with HIV-1. Dovato, a two-drug combination, was approved by the U.S. Food and Drug Administration in April for the treatment of HIV-1 infection in adults with no antiretroviral treatment (ARV) history and with no known resistance to either dolutegravir or lamivudine.
When these data were presented in July, Smith noted the importance of ViiV’s focus on developing two-drug regimens over three-and more treatment programs.
“With HIV now considered a chronic condition and people living with HIV needing antiretroviral treatments for life, taking fewer medicines over a lifetime has become an important consideration for the community,” she said.
