Long-Acting HIV Treatment Shows Promise with Nearly 100% Viral Suppression Rates

Strategic Insights -

Researchers from the CALIBRATE study published final results in the journal AIDS, demonstrating that a long-acting injectable antiretroviral, lenacapavir, can maintain nearly 100% viral suppression rates when administered with daily antiretrovirals to individuals starting HIV treatment for the first time. The study's findings suggest that a twice-yearly first-line regimen, if successful, would be a significant advancement in HIV treatment. With no other equally durable meds currently available, lenacapavir must be used in combination with daily antiretrovirals for HIV treatment. The Phase II CALIBRATE trial enrolled 183 previously untreated people with HIV between November 2019 and August 2020.

Key Takeaways:

  • Nearly 100% of participants maintained viral suppression after 132 weeks of treatment with lenacapavir administered once every six months along with daily antiretrovirals.
  • The study's findings support future development of lenacapavir-containing regimens for HIV-1 treatment.
  • Lenacapavir has been approved by the FDA as a component of combination therapy for heavily treatment-experienced people with multidrug-resistant HIV.
  • The most effective group maintained viral suppression at a rate of 100% after 132 weeks, with the majority experiencing mild to moderate injection-site reactions.
  • No serious treatment-related adverse events were reported, but 5 individuals in Group 1 and 3 in Group 2 discontinued lenacapavir due to adverse reactions.
  • The study population was racially diverse with about half Black and 45% Latino, but more than 90% were men.
  • The median CD4 T-cell count was approximately 450, and about one in six started with a high viral load above 100,000 copies.
  • Researchers reported 54-week data showing that 90% and 92% of participants in certain groups had undetectable virus; by 80 weeks, these rates increased to 87% and 92%.
  • Participants in all four groups gained around 250 CD4 cells, and Group 4 concluded the trial at the 80-week point.
  • Four people developed lenacapavir resistance mutations, but treatment was generally well-tolerated.

Statistics:

  • 183 participants were enrolled in the CALIBRATE study between November 2019 and August 2020.
  • 98% to 100% of participants in Groups 1, 2, and 3 maintained viral suppression at 132 weeks.
  • Four people developed lenacapavir resistance mutations.
  • Participants in the study gained approximately 250 CD4 cells across all four groups.
  • No serious treatment-related adverse events were reported, but 5 individuals in Group 1 and 3 in Group 2 discontinued lenacapavir due to adverse reactions.
  • The study population was racially diverse with about half Black and 45% Latino, but more than 90% were men.

Sources:

  • The study was published in the journal AIDS, "Lenacapavir-containing combinations achieved and maintained high rates of virologic suppression in treatment-naive participants through Week 132," authors' conclusions.
  • Gilead Sciences, "Lenacapavir (Sunlenca): a Long-Acting Injectable Antiretroviral for HIV Treatment."
  • Food and Drug Administration (FDA), "Lenacapavir (Sunlenca): Approved for HIV Treatment."