Multidrug-resistant HIV: an update on therapeutic options after Trogarzo’s withdrawal

The TRT-5 CHV collective, an interassociative treatment and therapy research group, is concerned about the future of care for people living with multidrug-resistant HIV while the drug Trogarzo – the monoclonal antibody ibalizumab – is withdrawn from the European market. collective
denounces the profit law in the pharmaceutical industry.

In an April 27 press release, biopharmaceutical company Theratechnologies announced that it would end its European commercialization activities for Trogarzo and return the drug’s European commercialization rights to TaiMed – the company that developed it – within the next 180 days.

“Prices and reimbursement conditions for Trogarzo in the main European countries have not been satisfactory for Theratechnologies, the company complains. Although Trogarzo is an important and effective treatment for people living with HIV-1, continued commercial sale of Trogarzo at the prices and reimbursement terms offered by the various European governments would have resulted in continued losses for Theratechnologies. »

The TaiMed company, for its part, pointed this out “Determined to continue commercializing Trogarzo and making the drug available to patients who need it and has already started searching for a new commercial partner for the European region. »

Have molecules with different mechanisms of action

Not enough to calm down TRT-5 CHV that warns: “The unavailability of Trogarzo in France risks exacerbating the critical condition that patients are in, while their lives and care pathways are already very difficult. » Professor Jean-Michel Molina, specialist in infectious diseases at the Paris Cité University and the Saint-Louis and Lariboisière Hospitals (AP-HP), also regrets with the “Quotidien”, “that public health interests collide with commercial issues”.

He remembers that “Fortunately, these multifault situations remain the exception and affect approximately one in 1,000 patients.” and specifies that in France “Since 2019, 12 patients have been treated with Trogarzo in Early Access”. Nonetheless, he continues “These are complex and precarious situations that can progress to the AIDS or death phase, tripling the risk of death in these patients.”. It is therefore essential for the person skilled in the art to have effective molecules with different mechanisms of action in order to circumvent cross-resistance.

Lenacapavir stands out

Aside from Trogarzo, which has the disadvantage of being administered intravenously every 15 days, a few other molecules are available. For Professor Molina, lenacapavir, which is also in early access, seems to be the most promising. “It showed anti-viral in vitro Regardless of the virus strain, as it targets the capsid of the virus, a highly conserved protein, and has the advantage of being able to be administered once a week in tablet form or every six months as a subcutaneous injection, which has great advantages in terms of compliance”he explains.

The phase 3 capella study in which Professor Molina participated, recently published in the New England Journal of Medicine, confirms lenacapavir’s potent antiviral activity against HIV-1 and its good tolerability. “Lenacapavir is probably more potent than ibalizumab in terms of antiviral potency”specifies the infectiologist and affirms that these new results should lead to the forthcoming commercialization of lenacapavir.

Fuzeon (enfuvirtide) has been available since 2003. “While it is interesting for its mechanism, which inhibits fusion between the viral envelope and the target cell, its use has been gradually reduced due to a complex administration method involving two subcutaneous injections per day, causing nodules.”, explains Professor Molina. As for Rukobia (Fostemsavir), which received marketing approval in early 2021, its main advantage is that it comes in the form of an extended-release oral tablet.

“When all of these drugs have rare indications, it’s important to maintain their access for these patients in dangerous situations.”, emphasizes the infectiologist, adding that these treatments can also be combined. In the international Capella study, in which a total of 72 patients took part, 24% of the patients received trogarzo in addition to lenacapavir, 11% received rukobia and 7% received fuzeon. “Overall, more than 80% of the patients in the study were virologically controlled”reports Professor Molina.

*Collective of associations fighting against HIV, hepatitis and STIs around the challenges of clinical research and therapeutic advances to defend the interests of the people affected

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