Theratechnologies Inc T.TH

Couple of recent articles about Trogarzo

[scarlet1967]

Disease Severity Impact on Long-Term Virologic Response to Ibalizumab in Expanded Access Protocol

• • December 2020
  • Open Forum Infectious Diseases 7(Supplement_1):S532-S532

"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

Long-Term Efficacy, Safety, and Durability of Ibalizumab-Based Regimens in Subgroup of TMB-202 Participants

• December 2020
• Open Forum Infectious Diseases 7(Supplement_1):S542-S543

"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

[SPCEO1]

The drug clearly works well. It is hard to fathom why it has not sold better than it has.

[scarlet1967]

Well of reasons we already know, not user friendly and expensive, having said that all viruses mutate eventually thus more cross resistance so as other ART drugs start failing the doctors/patients have no choice to use a superior treatment regardless of the cost and method of administration. 

[SPCEO1]

I would argue the sales problems with Trogarzo had more to do with a very small trial that meant most doctors did not have a chance to have ownership in the drug's development and also the fact that a very small drug company with reduceed ability to access doctors versus big drug company sales reps, played a big role. For example, Fostemsavir had a much larger and longer trial and it is sold

[qwerty22]

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

[scarlet1967]

These articles are very relevant and the cross resistance is real therefore I don't think we should write off Trogarzo all together, it will not even come close to initially projected sale estimates but it definitely has room for further growth.