ViiV's Tivicay superior to Kaletra in Phase IIIb DAWNING trial for HIV-1 infection

In July, ViiV Healthcare Ltd. (Brentford, U.K.) said data from the Phase IIIb DAWNING trial to treat HIV-1 infection showed that a regimen containing Tivicay dolutegravir showed superior efficacy and had a favorable safety profile compared with a regimen including Kaletra lopinavir/ritonavir. An IDMC recommended discontinuation of the study's Kaletra arm based on differences in the rates of virologic non-response and increasing differences in virologic failure between patients in the Kaletra and Tivicay arms. ViiV amended the trial protocol to allow Kaletra patients to switch to Tivicay.

The open-label, international trial enrolled 627 patients who failed first-line treatment with 2 nucleoside reverse transcriptase inhibitors (NRTIs) to receive treatment with 2 NRTIs plus once-daily 50 mg oral Tivicay or either of two dosages of Kaletra from AbbVie Inc. (NYSE:ABBV). The primary endpoint is the proportion of patients with virologic success, defined as HIV-1 RNA levels of <50 copies/mL at week 48. Secondary endpoints include the change from baseline in CD4+ lymphocyte count at weeks 24 and 48, proportion of patients with HIV-1 RNA levels of <50 copies/mL at week 24 and <400 copies/mL at weeks 24 and 48, proportion of patients without virologic or tolerability failure by weeks 24 and 48, time to viral suppression, incidence of disease progression up to week 48, safety, change from baseline to weeks 24 and 48 in total cholesterol/HDL-C ratio, change from baseline to weeks 4, 24 and 48 in Gastrointestinal Symptom Rating Scale (GSRS), HIV Treatment Satisfaction Questionnaire (HIVTSQ) and Morisky Medication Adherence 8-item scale (MMAS-8) and incidence of treatment-emergent genotypic and phenotypic resistance...