Date: 2017-07-25
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 9th International Aids Society Conference (IAS 2017)
Company: ViiV Healthcare (UK - USA)
Product: Tivicay® (dolutegravir)
Action
mechanism:
- integrase inhibitor. Dolutegravir is an investigational integrase inhibitor (INI) currently in development by Shionogi-ViiV Healthcare LLC for the treatment of HIV. It is currently the only once-daily, unboosted INI in Phase III clinical development. Integrase inhibitors 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. Given the stage of development of this investigational HIV therapy, the full picture of the efficacy and safety of dolutegravir has not been conclusively determined.
Disease: HIV infection
Therapeutic
area: Infectious diseases
Country:
Trial
details:
- DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs. The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.
- Adult patients failing first-line therapy, with HIV-1 RNA ?400 copies(c)/mL, were randomised (1:1, stratified by baseline plasma HIV-1 RNA and number of fully active background NRTIs) to 52 weeks of open-label treatment with DTG or LPV/RTV combined with an investigator-selected dual NRTI background, including at least one fully active NRTI. (NCT02227238)
Latest
news:
- • On July 25, 2017, ViiV Healthcare, a specialist HIV company, majority owned by GSK, with Pfizer. and Shionogi as shareholders, announced positive interim results from the DAWNING study. This non-inferiority study has been conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir and 2 NRTIs in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.
- The study’s Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.
- The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001).
- Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.
Is
general: Yes
