The multinational pharmaceutical company Gilead has announced the launch of its drug lenacapavir (Sunleca) in Spain, intended for patients with multi-resistant HIV, who until now had very few therapeutic options and were in a very vulnerable situation, as they have a higher risk of suffering from opportunistic infections, comorbidities such as cardiovascular diseases and cancer, progression to AIDS and death. In addition, they face greater drug toxicity due to more complex treatment regimens, with more tablets and daily doses.
It is estimated that approximately 250 people in Spain will benefit from this drug, which has been funded by the Ministry of Health since July 1 and is the first to be administered twice a year subcutaneously. In the Capella clinical trial, which led to the approval of lenacapavir, this drug demonstrated 83% efficacy in terms of virological suppression when combined with an optimized background treatment for patients with multi-resistant HIV. Spain has been the eighth country in the world to launch lenacapavir and one of the 11 countries that participated in the Capella clinical trial.
“We have been working on this drug for a long time, we have tested more than 4,000 molecules to develop lenacapavir. But having a drug with 83% efficacy in these multi-resistant patients has made these 16 years worthwhile,” said Pau Arbós, director of the HIV Unit of Gilead Spain and Portugal, during the meeting ‘Multi-drug resistance in HIV: a major clinical and public health challenge’.
Reducing the risk of multidrug-resistant HIV transmission
José Luis Blanco, a researcher on the study and a specialist in the Infectious Diseases Service at the Hospital Clínic in Barcelona, stressed that the collaboration of 42 centres around the world was necessary to recruit 72 patients for the study. In the trial, 50% of the participants were resistant to four families of drugs, and 75% were in a state of severe immunosuppression, which put them at high risk of opportunistic infections. Blanco stressed that “the results regarding the virological response rate in patients with highly resistant viruses are very positive.”
These patients are resistant to at least three families of antiretrovirals or to two families and are intolerant to a third. Although the number of those affected is small, their treatment represents a major challenge for specialists. Furthermore, from a public health perspective, the lack of control of the virus increases the risk of transmission of multi-resistant HIV.
Lenacapavir acts at three different points in the HIV life cycle and is administered by a six-monthly subcutaneous injection, which simplifies treatment.
The new antiretroviral addresses the problem of resistance thanks to its unique mechanism of action. Blanco explains that this capsid inhibitor acts at three different points in the life cycle of the virus. He also highlighted the advantages of its dosage, “as it is a six-monthly subcutaneous injection that will simplify its administration to the patient” and its safety and tolerability profile, since all the adverse effects observed during clinical development were mild or moderate and “only one person stopped treatment in week 26 due to a mild adverse effect.”
For all these reasons, the arrival of lenacapavir in Spain represents “great hope and improvement”, as commented by Dr. Arbós, who adds that “innovation saves lives”. “The low prevalence may make us think that it is a small problem, but multi-resistance presents a great clinical challenge”, he concludes.
