RE:RE:RE:RE: PLWH and Nash I think I've always tried to point out that I think THTX's data is a bit of an ugly duckling. It has the potential to be a beautiful swan but it's flawed.
HIV is both the thing that has highlighted it's potential but it's also a bit of an anchor. I think because this came to the regulators via hiv data that if the company wanted to move into the general population at a higher trial then there was an insistence from the regulators that this be done as a head-to-head against hiv patients. I don't think there is necessarily a thought this drug has any special ability in hiv patients either compared to the general population or relative to other drugs that might help with NASH. I think at least for one more step it remains anchored to hiv until it has proved itself with the general population. If it ever got into a trial with the general NASH population and that data looked okay then it could break from hiv. At that point it would be a purely commercial decision on the side of the company, I can see arguments pro and con for sticking with hiv. I don't want to appear cynical but I thinking the drug is linked with hiv because it's come to the regulator via a weird path and that raises question that need to answer if the are going to pivot to the general population at a higher trial phase. I don't think they are specifically doing this to offer hiv patients different options.
scarlet1967 wrote: I think it's up to the Doctors', discretion as in case of PLWH the disease can progress faster than the general population so with currently only one drug approved they might bite the bullet and go with it however since HiV patients were excluded one can question MDGL's drug efficacy on this subgroup as HIV liver is prone to fat accumulation and fat in some cases can act as a toxic substance cussing inflammations/infections. Also if the drug's label specifically excludes PLWH it might be an insurance issue.
palinc2000 wrote: If HIV patients are diagnosed for Nash they would not be prescribed the Madrigal drug?
scarlet1967 wrote: Exclusion criteria
Patients who meet any of the following criteria will be excluded from participation in the study...."
Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, who are known to be positive for HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections."
https://www.nature.com/articles/s41591-023-02603-1
I don't believe they had any HIV positive patients enrolled in their trial like most of the current trials.
palinc2000 wrote: We were told a few years ago that FDA insisted that THTX proposed Phase 3 trial include the general Nash population and not only PLWH .....In hindsight that was bad news since THTX could not handle such a large trial
Does anyone have access if any to the subset data from the Madrigal trial on results in theur Phase 3 trial for PLWH?
Scarlett and or Qwerty are the only posters imo on this MB who could find out but of course others are invited also
Maybe just maybe there could be an opportunity for going back to the original Nash protocol to include only PLWH