March 10, 2020
Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study
-- Results Presented at CROI 2020 Support Further Evaluation of Vesatolimod as Part of Investigational Curative Regimens Aimed at Achieving ART-Free Control of HIV --
“This is the first study done in people that has shown with an immunotherapy that you can enhance immune function resulting in both a smaller viral reservoir and an increased time to viral rebound after treatment is interrupted. The effects are modest, and no one came close to any definition of a cure, but the data suggests real progress might be made when the drug is used in combination with other approaches,” said principal investigator
“While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy and potential complications,” said
Abstracts on cure research strategies presented at CROI 2020 include:
Oral 3982: Safety and Analytic Treatment Interruption Outcomes of Vesatolimod in HIV Controllers
This randomized, double-blind, placebo-controlled study evaluated 25 people living with HIV who had demonstrated partial viral suppression (HIV RNA of 50 to 5,000 copies per mL) prior to starting ART, a group referred to as “HIV controllers”. Participants received 10 biweekly doses of the investigational TLR7 agonist vesatolimod or placebo while continuing ART, followed by a treatment interruption in which they stopped therapy and were carefully monitored for viral rebound and safety.
The study found that vesatolimod was associated with a longer period of viral suppression following treatment interruption compared with placebo. The median time to viral rebound (>50 copies/mL) was 4.1 weeks for the vesatolimod group compared with 3.9 weeks for placebo (p=0.036). For rebound to >200 copies/mL, the median time was five weeks for vesatolimod compared with four weeks for placebo (p=0.024). Four individuals in the vesatolimod group had no virologic rebound (>50 c/mL) for six or more weeks.
Vesatolimod is an investigational agent and has not been approved anywhere globally; its safety and efficacy has not been established.
Oral 4545: Combined Active and Passive Immunization in SHIV-Infected Rhesus Monkeys
A separate study evaluated the potential of combining an investigational therapeutic vaccination, investigational broadly neutralizing antibodies (bNAbs), and Gilead’s investigational TLR7 agonist vesatolimod as an HIV cure strategy to activate and eliminate the latent HIV reservoir. HIV bNAbs are a class of antiviral and immunotherapy agents that were originally derived from HIV-infected individuals with a strong anti-HIV antibody response that are being developed to target HIV.
In the study, 49 Simian-Human Immunodeficiency Virus (SHIV)-infected rhesus monkeys were given tenofovir disoproxil fumarate/emtricitabine/dolutegravir (TDF/
Poster 4549: PGT121 and Vesatolimod in Chronically Treated SHIV-Infected Rhesus Monkeys
This study evaluated the efficacy of the investigational combination of broadly neutralizing antibodies (bNAbs) with vesatolimod in SHIV-infected rhesus monkeys who had been treated with continuous daily suppressive ART (TDF/
“These data help inform strategies aimed at a functional cure for HIV,” said co-author
Additional studies focused on HIV cure research presented at CROI 2020 include:
- Oral 3126: Safety & Pharmacokinetics of GS-9722 in HIV-Negative Participants & People with HIV
- Poster 1708: Impact of GS-986, PGT121 & N6-LS on CNS Immune Activation in SHIV-infected Macaques
- Poster 3797: NOD2 & TLR8 Agonists Enhance IL-15-Mediated Activation of HIV Expression
Vesatolimod, the bNAbs PGT121 and GS-9721, and the other experimental compounds noted are investigational and are not approved by the
There is no cure for HIV infection or AIDS.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving vesatolimod, GS-9722 and other investigational compounds, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of these investigational compounds, and as a result, they may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended
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