Ibalizumab, an intravenous humanised monoclonal antibody fusion inhibitor that binds CD4, has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency for adults who are heavily treatment-experienced and who cannot be successfully treated with other currently available therapies (e.g., multi-drug resistant HIV). In a phase III trial, 43% of patients achieved HIV RNA suppression after 25 weeks of treatment (in combination with other antiretroviral drugs). Patients with ongoing detectable viremia who lack sufficient treatment options to construct a fully suppressive regimen may be candidates for this drug.
Long-acting injectable antiretroviral therapies
Long-acting injectable antiretroviral therapies (e.g., cabotegravir, rilpivirine) that are administered monthly or every other month have entered phase III clinical trials for both the prevention and treatment of HIV infection, and will potentially be available for clinical use for certain patient groups within the next few years. An injectable regimen of cabotegravir plus rilpivirine administered every 4 or 8 weeks was found to be as effective as oral cabotegravir plus abacavir/lamivudine at maintaining viral suppression for up to 96 weeks, and was well accepted and tolerated.
PRO 140 (a humanised form of the PA14 antibody) is a monoclonal antibody targeted against the C-C chemokine receptor type 5 (CCR5) receptor on T-lymphocytes that has shown significant antiviral activity in three small trials, but is still considered an investigational drug.
Other antiviral therapies
Maraviroc (a CCR5 receptor antagonist) and enfuvirtide (a fusion inhibitor, which binds to the gp41 or chemokine receptors and inhibits entry of the virus into immune cells) are approved by the FDA for HIV infection; however, their exact place in therapy is yet to be determined and guidelines do not currently recommend their use. Other antiviral therapies currently under investigation include attachment inhibitors and maturation inhibitors Fostemsavir is an investigational, first-in-class attachment inhibitor in development for the treatment of HIV-1 infection. It works by binding directly to the glycoprotein 120 (gp120) subunit on the surface of the virus. An application for approval has been submitted to the FDA.
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