Week 48 results from phase III TANGO study were announced. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a Tenofovir alafenamide fumarate ( TAF )-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen ( 2DR ) of Dolutegravir plus Lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA greater than or equal to 50 copies per millilitre ( c/mL ) using the FDA Snapshot algorithm at week 48.
No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.
The safety results for the 2DR of Dolutegravir plus Lamivudine were consistent with the product labelling for the medicines.
The single-pill, 2DR of Dolutegravir plus Lamivudine, was authorised in the United States earlier this year 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.
It was also authorised in Europe in July 2019 for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor ( INI ) class, or Lamivudine.
TANGO is a randomised, open-label, active-controlled, multicentre study to assess the antiviral efficacy and safety of switching to a 2DR consisting of Dolutegravir plus Lamivudine in HIV-infected adults who are virally suppressed and stable on a TAF-containing regimen.
Study participants were HIV-1 infected adults on a TAF-containing regimen with HIV-1 RNAless than 50c/mL for at least six months, without prior virologic failure, no historical nucleoside reverse transcriptase inhibitors ( NRTI ) or INI major resistance mutation, and no evidence of hepatitis B infection.
Participants were randomised to switch to Dolutegravir plus Lamivudine or continue on the TAF-containing regimen through week 148.
The primary endpoint was the proportion of participants with a viral load of more than 50 c/mL at week 48 ( FDA Snapshot algorithm ) for the Intention To Treat-Exposed ( ITT-E ) population.
Dolutegravir is an INI for use in combination with other antiretroviral agents for the treatment of HIV. INIs block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells ( T-cells ). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection.
Dolutegravir plus Lamivudine ( Dovato ) is a once-daily, single-pill, 2-drug regimen that combines the INI Dolutegravir ( 50 mg ) with the NRTI Lamivudine ( 300 mg ). ( Xagena )
Source: ViiV Healthcare, 2019