RE:RE:Couple of recent articles about Trogarzo In my view it comes down to one word, stability. Since the introduction of new ART drugs in the early 2010's the whole HIV+ population has found much more stability. That's a phenomenon that has been well described in the general population and has lead to much healthier lives. That stability has not bypassed the MDR segment. Yes they have fewer options but they can still find stable regimens. When research started on Trogarzo that stability wasn't there, when THTX bought into Trogarzo that stability hadn't yet been described in the MDR population in the scientific literature. Now it has. The science says there has been a clear shift towards more stability in MDR population thru the 2010's. That process in my view has significantly reduced Trogarzo's market. People still lose stability, they still get to the end of the road for ART treatments and those people will benefit from Trogarzo because as you say the drug works but the trend over the past decade has been to lessen that flow of people to that desparate situation. I think there have been a number of publications over the past few years that show that process at work and I've heard and read a number of HIV treatment KOLs describe that process in practice.
I'm sure a superstar salesman can still work in that situation to find new ways to grow sales. Startraps idea that medics who want to intervene in treatment to take control of adherence with IV is one avenue. The drug might benefit from a sponsored study or some case reports demonstrating better adherence. But the basic clinical situation is clearly different to the way it was believed to be when THTX bought in and that in my view makes the expected target sales from that time not relevant anymore.
SPCEO1 wrote: The drug clearly works well. It is hard to fathom why it has not sold better than it has.
scarlet1967 wrote: "Background The principal goal of antiretroviral therapy (ART) is durable suppression of HIV RNA. In treatment-experienced (TE) patients, ongoing viremia can lead to further accumulation of drug resistance, increased morbidity and mortality. ART efficacy often depends on HIV disease severity; therefore, we sought to assess its impact on long-term virologic suppression in patients treated with Ibalizumab (IBA).
Conclusion In TE patients with advanced HIV disease, maximal viral suppression with IBA was observed regardless of BL CD4 or VL strata if patients remained on treatment. This demonstrates that TE patients across the spectrum of HIV disease, can achieve viral suppression by using drugs with a new mechanism of action." https://www.researchgate.net/publication/348173121_1008_Disease_Severity_Impact_on_Long-Term_Virologic_Response_to_Ibalizumab_in_Expanded_Access_Protocol_TMB-311
"Background Third line antiretroviral regimens have been associated with suboptimal virologic suppression, due to drug cross-resistance and regimen complexity. Yet, in treatment-experienced (TE) HIV patients, ART durability is essential for preventing further resistance and decreasing HIV-associated morbidity and mortality. Ibalizumab (IBA), the first long-acting, post-attachment inhibitor approved to treat multi-drug resistant (MDR) HIV, may support regimen durability given its directly observed administration.
Conclusion Data from 12 patients who received IBA for an average of 9 years validate the long-term efficacy and safety of IBA in TE patients. Importantly, for most patients, the durability of virologic response was maintained with minimal adjustments to the OBR. Altogether, these data demonstrate the contribution of IBA towards durable viral suppression in TE HIV patients with limited therapeutic options."
https://www.researchgate.net/publication/348173483_1027_Long-Term_Efficacy_Safety_and_Durability_of_Ibalizumab-Based_Regimens_in_Subgroup_of_TMB-202_Participants