HIV medications expected to be approved in 2019:
Cabotegravir/rilpivirine long-acting injectable (Name tba): Consisting of ViiV Healthcare’s integrase inhibitor cabotegravir and Janssen’s NNRTI rilpivirine, this long-acting injectable can be administered every four to eight weeks. Clinical trials used a cabotegravir injection of 400 mg plus 600 mg rilpivirine injection. The dose consisted of two 2-mL injections. While oral rilpivirine must be taken with food, this injectable does not. Researchers found there was an induction phase with oral medication, which is also expected to be used when the drug goes to market. A tablet form of cabotegravir tablet may not be available for other use.
Fostemsavir: An entry inhibitor currently under development by ViiV Healthcare and GlaxoSmithKline, fostemsavir is a prodrug, which means it’s an inactive drug. Once taken, it does not work until the body converts it into an active form. In the body, fostemsavir is converted to temsavir. In clinical trials, participants took the drug after eating and in combination with one or more other antiretrovirals. It is recommended for heavily treatment-experienced patients with a history of resistance to three classes of antiretrovirals who also have a background therapy of other active antiretroviral drugs. It has not been studied in treatment-naïve patients, pregnant women, or people under age 18.
2020 and Beyond:
Leronlimab (PRO 140): After four years of trials, drugmaker CytoDyn now has the data to submit to the Food and Drug Administration for approval. This CCR5 antagonist would be dosed weekly and delivered subcutaneously. This would be the first in a new class of therapeutics called viral-entry inhibitors. It works by masking CCR5, thus inhibiting HIV’s ability to enter healthy T cells.
PGT121: A small study showed that an experimental monoclonal antibody called PGT121 led to viral suppression that lasted for up to six months in HIV-positive people who started with a low viral load. Being developed by a collaboration that includes the International AIDS Vaccine Initiative, the Bill & Melinda Gates Foundation, the Scripps Institute, and Theraclone Science, the recombinant monoclonal antibody targets the V3 glycan site on the outer envelope of HIV. At the 2019 Conference on Retroviruses and Opportunistic Infections, researchers reported that two participants with low viral loads experienced treatment-free viral suppression, which for one lasted over five months and for the other was still ongoing at six months. PGT121 could eventually become a very long-acting HIV medication.
UB-421: In a phase 2 trial, this broadly neutralizing antibody targeting domain 1 of CD4 was shown to maintain viral suppression after antiretroviral therapy ended. Weekly or biweekly intravenous infusions of UB-421 kept the viral loads of all 29 participants suppressed after they stopped taking oral HIV meds.
GS-6207: Currently in a phase 1b proof-of-concept study, GS-6207, developed by Gilead Sciences, is a first-in-class capsid inhibitor that interferes with the transport of the viral genetic material and replication of HIV’s genetic blueprint into a host cell’s nucleus. It is given subcutaneously. At CROI 2019, researchers noted, based on an early clinical trial, that they believed it could be safely administered every three months.
Disulfiram: This drug, currently FDA-approved for helping in the management of alcohol use disorder, is being tested as a latency-reversing agent, a substance that draws HIV out of hiding so the body’s immune system and antiretroviral drugs can attack the virus. A recent study showed promise in this area.
Lefitolimod: Currently in phase 1b/2a development as an HIV therapeutic, lefitolimod is a type of latency-reversing agent called a toll-like receptor agonist. Researchers believe it may also improve the body’s immune response to HIV in addition to its effect on latent virus cells. Researchers in Denmark tested lefitolimod in the TEACH study, which showed it to be safe in early phase trials.