ViiV's HIV Drug Hits Endpoints in Late-Stage Comparison Trial
GlaxoSmithKline’s ViiV Healthcare said HIV patients who switched to Dovato (dolutegravir plus lamivudine) had similar success in maintaining viral suppression at 48 weeks as patients on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs.
ViiV, which is also backed by Pfizer and Shinogi Limited, said its Phase III TANGO study met its primary endpoint of non-inferiority. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study, ViiV said in its announcement this morning. The safety results for Dovato were consistent with the product labeling for the medicines. Full results from the TANGO study will be presented later this month at the 10th International AIDS Society Conference on HIV Science in Mexico City.
Kimberly Smith, head of global research and medical strategy at ViiV, said the TANGO study was designed to ask whether or not HIV patients who were virally suppressed could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. And, the 48-week results of the TANGO trial show that question has been answered in the affirmative.
“These Week 48 data clearly indicate that they can – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to Dovato,” Smith said in a statement.
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. The oral treatment contains dolutegravir, an integrase strand transfer inhibitor (INSTI), which prevents HIV replication, and lamivudine, a nucleoside reverse transcriptase inhibitor that interferes with the conversion of viral RNA into DNA. Dovato was approved for use in Europe earlier this month.
The TANGO trial included patients who were HIV-1 infected adults on a TAF-containing regimen with HIV-1 RNA<50c/mL for at least six months. The patients were also without prior virologic failure, had no historical nucleoside reverse transcriptase inhibitors (NRTI) or INI major resistance mutation, and no evidence of hepatitis B infection. Participants were randomized to switch to Dovato or continue on the TAF-containing regimen through Week 148. The primary endpoint was the proportion of participants with a viral load of >50 c/mL at Week 48 for the intent to treat population.
Earlier this year, HIV-focused ViiV submitted a New Drug Application to the FDA for approval of its monthly injectable combination of ViiV’s cabotegravir and Janssen’s rilpivirine (Edurant) as a treatment of HIV-1 in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. Deborah Waterhouse, ViiV’s chief executive officer, said the once-per-month injectable treatment has the potential to improve quality of life of HIV patients due, in part, to the dosing regimen. Waterhouse said the once-per-month dose provides a medication with the same level of safety and efficacy as today’s standard of care, an oral three-drug regimen that has to be taken every day. In June, the FDA granted the NDA Priority Review and set a target approval date of Dec. 29. In preparation for potential approval of the injectable, ViiV said it launched a study to evaluate approaches to implementing the once-per-month injectable treatment for HIV into clinical practice. The injectable will require monthly visits to a clinic for patients who currently only see their doctors a few times per year, but take numerous medications per day.