THTX's NASH protocol's advantages This is very current publication (September 2022) covering just about all aspects of HIV NAFLD/NASH.
“A high prevalence of fibrosis and rapid progression of fibrosis are seen in HIV associated NAFLD, with visceral fat as a major risk factor. Newer ART such as integrase strand inhibitors may have limited intrinsic hepatoxicity but do increase weight, which may secondarily lead to hepatic steatosis. Promising therapies for HIV-associated NAFLD include tesamorelin and CCR5 blockade agents.
Tesamorelin, a growth hormone releasing analog administered subcutaneously once daily and approved by the United States Food and Drug Administration (FDA) for HIV lipodystrophy, is an emerging therapy for HIV-associated NAFLD. Due to perturbations in growth hormone secretion with reduced pulsatile growth hormone in PLWH, weight gain and abdominal fat accumulation occur. Tesamorelin restores endogenous pulsatile growth hormone secretion and reduces visceral adiposity by stimulating lipolysis in HIV-infected patients. Correspondingly, it has been shown to reduce liver fat content and prevent fibrosis progression. Long-term treatment with tesamorelin also notably decreased markers of T-cell and monocyte/macrophage activity, suggesting reduction in immune activation and systemic inflammation in patients with HIV and NAFLD. Other classes of agents for NAFLD/NASH or reduction of hepatic fibrosis are under active evaluation (e.g., FXR agonists, thyroid hormone receptor agonists) in non-HIV infected populations and also show promising results, but studies in PLWH are lacking.”
https://www.natap.org/2022/HIV/Causes_and_outcomes_of_hepatic_fibrosis_in_persons.6.pdf
Therefore is an ongoing trial assessing among others the true prevalence of hepatic steatosis and NAFLD in PLWH.
From the description:
“The reported prevalence of NAFLD in PLWH without viral hepatitis co-infection ranges from 15-54% when assessed by imaging modalities and vibration-controlled transient elastography (VCTE), and is up to 73% in studies including liver biopsy, exceeding the reported prevalence of NAFLD in the general population.”
https://clinicaltrials.gov/ct2/show/NCT04795219
The prevalence of NAFLD in the US is estimated 25 percent of adult and NASH 5 percent!
NAFLD is estimated to be up to three times more prevalent in HIV patients compared to the general population, NAFLD progresses to NASH much faster in HIV and current studies/candidates under development “LACKING” HIV patients. Point is this is a very good publication for the MSL to use/sell the drug for aging MDR HIV patient with lipodystrophy and NAFLD/NASH and quite an advantage for THTX’s NASH asset compared with other protocols as the HIV/NASH cohort by itself is a big market of course if they don’t develop the drug for HIV NASH and other drugs get approved one can argue the doctors might try it on HIV patients but if a protocol include HIV patient(THTX’S NASH) and the drug get approved that would be the first choice, wouldn’t it?