qwerty22 wrote: Here are the results from IDweek website in a little more detail
"
Cohort 2 enrolled 38 patients with a median age of 53 years, mostly male (87%) and white (53%). At Baseline, median VL was 4.7 log10 copies/mL, CD4 cell count was 26 cells/mm3 and overall susceptibility score of 1. A ≥0.5 log10 decrease in VL from Baseline was achieved in 28 of 37 patients (76%) at Day 7. Of 24 patients who completed the Week 24 visit, 11 (46%) had HIV-1 RNA levels < 50="" copies/ml.="" of="" 17="" patients="" with="" a="" vl="" assessment="" at="" week="" 48,="" 8="" (47%)="" achieved="">< 50="" copies/ml.="" seven="" patients="" did="" not="" have="" a="" week="" 48="" endpoint="" because="" they="" withdrew="" from="" the="" study="" to="" receive="" commercial="" iba.="" at="" both="" timepoints,="" the="" median="" change="" in="" vl="" from="" baseline="" was="" -2.6="">10 copies/mL.
The most frequently reported treatment-emergent adverse events (TEAEs) were diarrhea (24%), headache (21%), and nausea, cough, rash, and fatigue (16% each). No injection site reactions related to IBA were reported. Most events were mild; 9 patients reported Grade ≥3 TEAEs. Two events were fatal (sepsis and cardiac arrest); neither related to IBA. One event of immune reconstitution inflammatory syndrome was reported and considered possibly related to IBA."
First on communication - You can PR this event in advance when the abstract gets accepted, you can put the poster on your website or you can do the bare mininimum and leave people to hunt down extra info themselves. I'm not seeing any real change in communication behaviour. We have to HOPE they are talking to the right people behind the scenes because there's no evidence they have changed their attitude to communicating with the general market.
So this is a new cohort different to the phase 3 people I assume. Still very, very sick people, two died on study and average cd4 cell count still very very low. Non of this really screams 90% efficacy/retention rate. 37 started, 2 died, you could say they had 17+7 still on treatment at 48 weeks. At best they had 15 with undetectable virus if you assume all those that switched to commercial were <50. we="" could="" be="" generous="" and="" drop="" the="" two="" fatalities="" and="" assume="" the="" best="" of="" the="" commercial="">50.>
24/35 made it to week 48 68%
15/35 undetectable virus 43%
Spceo if you plugged those percents into the bloomberg numbers as retention rates do the new patient/ ongoing patient numbers make more sense?
I understand recruitment at the cliniic might (should) be broarder and healthier and so maybe more prone to success but it would be nice to have that confirmed.
FredTheVoice wrote: Here is the news that MUSLIX is refering to:
MONTREAL, Oct. 03, 2019 (GLOBE NEWSWIRE) - Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that new 48-week data from the TMB-311 Extended Study confirms that Trogarzo® (ibalizumab) provides long-lasting viral suppression and a consistent safety profile with the pivotal Phase III study of 24 weeks. The results of the study were presented today at IDWeek ™ in Washington, DC, USA. The results come from the TMB-311 Extended Access Protocol. A total of 38 patients were enrolled in Cohort 2. These patients had a viral load less than 1000 copies / mL, were resistant to at least one antiretroviral of three different classes and had a viral sensitivity to at least one antiretroviral. In Cohort 2 patients, the reduction in viral load at 24 weeks and at 48 weeks was similar. Respectively, 46% and 47% of patients taking Trogarzo®, combined with an Optimized Baseline Treatment (OBT), including at least one functional agent, had their viral load reduced and dropped below 50 copies / mL. In addition, at 24 but also at 48 weeks, the reduction in median viral load was -2.6 log10 copies / mL. This far exceeds the original goal of a reduction? 0.5 log10 copies / mL. Notably, a viral load below 50 copies / mL is considered undetectable and patients can not pass HIV to others.
FTV.