Dual dolutegravir/lamivudine submitted to US FDA as switch option

18 October 2019. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 16 October 2019, ViiV Healthcare reported that the company had submitted a supplemental new drug application to the US FDA to use dolutegravir/lamivudine as a switch options for adults with undetectable viral load on their current combination. [1]

This is based on results from the phase 3 TANGO study, reported at IAS 2019. [2, 3]

The current indication, both in the EU and the US is for use as initial ART in people without resistance to either drug.

The fixed dose combination (FDC) of dolutegravir is marketed with the trade name Dovato.

References

1. ViiV Healthcare press statement. ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1 (16 October 2019).
   https://viivhealthcare.com/en-gb/media
2. van Wyk J et al. Switching to DTG+3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 24 weeks (TANGO Study). 10th IAS Conference on HIV Science (IAS 2019), 21-24 July 2019, Mexico City. Late-breaker oral abstract WEAB0403LB.
   http://programme.ias2019.org/Abstract/Abstract/4903
3. Collins S. Switching to dolutegravir/lamivudine dual therapy is non-inferior to TAF-based triple therapy at week-48 in TANGO study. HTB (24 July 2019).
   https://i-base.info/htb/36450