Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vesatolimod · 4 trials · 3 indications
An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation.
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the last exposure date after permanent discontinuation of study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. The severity grades were defined by Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, Antiviral Toxicity Grading Scale, Version 01 April 2015. The CTCAE v5 grading scale was used to grade AEs determined to be cytokine release syndrome and infusion-related reactions. The grading for both scales are as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening, Grade 5 = Death.
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
AE was any untoward medical occurrence in a clinical study participant administered a medicinal product (MP), which did not necessarily had a causal relationship with treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with use of MP, whether or not considered related to MP. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation. TESAEs: event that resulted in following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; medically important event or reaction: such events might not have been immediately life-threatening or resulted in death or hospitalization but may jeopardize participant or may require intervention to prevent one of the other outcomes constituting SAEs.
The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.
| Arm | Type | Description |
|---|---|---|
| VRC07523LS + CAP256V2LS + Vesatolimod (VES) | EXPERIMENTAL | In Period 1 (Days 0-28), participants will receive ART through Period. On Days 0 \& 14, participants will be administered VES 6mg orally and on Day 28, participants will be administered VES either 6 or 8mg orally. VRC07-523LS \& CAP256V2LS 20mg/kg will be administered intravenously on Day 7. In Period 2 (Days 29-133 or until ART restart), participants will discontinue ART at Day 35 and remain off ART until reaching ART restart criteria. Participants will receive VES 6 or 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA is \>=5000 copies/mL. In Period 3, (Days 134-336 or until ART restart), participants will continue ATI and no study treatment will be administered. In Period 4, (Days 337-413) participants who have not met ART restart criteria by Day 337 may choose to restart ART (Period 4a) or may choose to continue ATI until end of study (Period 4B). Any participants who meet ART restart criteria before the end of the study will remain in follow-up on ART (Period 4A). |
| Placebo 4 Weeks (Cohort A) | PLACEBO_COMPARATOR | Placebo tablet once a week for 4 weeks |
| Vesatolimod 1 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 4 weeks |
| Vesatolimod 2 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 4 weeks |
| Vesatolimod 4 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 4 weeks |
| Placebo 8 Weeks (Cohort B) | PLACEBO_COMPARATOR | Placebo tablet once a week for 8 weeks |
| Vesatolimod 1 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 8 weeks |
| Vesatolimod 2 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 8 weeks |
| Vesatolimod 4 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 8 weeks |
| Placebo 12 Weeks (Cohort C) | PLACEBO_COMPARATOR | Placebo tablet once a week for 12 weeks |
| Vesatolimod 1 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 12 weeks |
| Vesatolimod 2 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 12 weeks |
| Vesatolimod 4 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 12 weeks |
| Vesatolimod | EXPERIMENTAL | Participants in Period 1 will receive 10 doses of vesatolimod (4 mg to 8 mg) once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) will discontinue ART and vesatolimod and will be monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restart ART during Period 2 due to virologic rebound will complete the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who complete 24 Weeks of ATI without restarting ART will move onto Period 3 and have 2 options. They can remain off ART for up to an additional 24 weeks. Those who restart ART at the start of Period 3 will complete ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| Placebo | EXPERIMENTAL | Participants in Period 1 will receive 10 doses of placebo matched to vesatolimod once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) will discontinue ART and placebo and will be monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restart ART during Period 2 due to virologic rebound will complete the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who complete 24 Weeks of ATI without restarting ART will move onto Period 3 and have 2 options. They can remain off ART for up to an additional 24 weeks. Those who restart ART at the start of Period 3 will complete ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| Vesatolimod 1 mg (Cohort 1) | EXPERIMENTAL | Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen |
| Vesatolimod 2 mg (Cohort 2) | EXPERIMENTAL | Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen |
| Vesatolimod 4 mg (Cohort 3) | EXPERIMENTAL | Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen |
| Vesatolimod 6 mg (Cohort 4) | EXPERIMENTAL | Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen |
| Vesatolimod 8 mg (Cohort 5) | EXPERIMENTAL | Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen |
| Vesatolimod 10 or 12 mg (Cohort 6) | EXPERIMENTAL | Vesatolimod 10 or 12 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen. Participants will receive 3 administrations of 10 mg, followed by 7 administrations of 12 mg (after review of 10 mg safety data) |
| Vesatolimod 12 mg (Optional Cohort 7) | EXPERIMENTAL | Vesatolimod up to 12 mg for up to 127 days for up to 10 total doses administered following overnight fasting, while continuing their existing ARV regimen |
| Vesatolimod 6 mg with an acidic solution (Optional Cohort 8) | EXPERIMENTAL | Vesatolimod 6 mg for 127 days for up to 10 total doses administered with an acidic solution (cranberry juice), while continuing their existing ARV regimen |
| Vesatolimod up to 12 mg (Cohort 9) | EXPERIMENTAL | Vesatolimod up to 12 mg for 127 days for up to 10 total doses administered following a moderate-fat meal, after the review of the data from the highest tolerated fasted dose cohort while continuing their existing ARV regimen |
| Placebo (Cohorts 1-9) | PLACEBO_COMPARATOR | Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen |
| Name | Type | Description |
|---|---|---|
| Vesatolimod | DRUG | Administered orally |
| VRC07523LS | BIOLOGICAL | Administered intravenously |
| CAP256V2LS | BIOLOGICAL | Administered intravenously |
| Placebo | DRUG | Placebo to match vesatolimod tablet administered orally |
| ART | DRUG | ART regimens administered in accordance with their prescribing information. The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc. |
| ARV regimen | DRUG | Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc. |
Key Inclusion Criteria: * Age ≥ 18 years * Females recruited from the Females Rising through Education, Support, and Health (FRESH) acute human immunodeficiency virus (HIV) infection cohort. * Plasma human immunodeficiency -1 (HIV-1) ribonucleic acid (RNA) levels \< 50 copies/mL at the screening vi...
Vesatolimod is an investigational small molecule being studied for the treatment of chronic Hepatitis B and HIV-1 infection. It is being developed by Gilead Sciences, Inc. (NASDAQ: GILD) and is currently in Phase 2 clinical development for these infectious disease indications.
Vesatolimod is a Toll-like receptor 7 (TLR7) agonist. It works by stimulating the immune system to recognize and fight viral infections, including chronic Hepatitis B and HIV-1. This mechanism is being evaluated in clinical trials to assess its safety and efficacy.
Vesatolimod is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the drug's safety and efficacy for chronic Hepatitis B and HIV-1 infection.
Vesatolimod is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for chronic Hepatitis B and HIV-1 infection, with studies evaluating safety, efficacy, and biological activity.
Vesatolimod has been studied in several completed clinical trials. NCT02166047 evaluated its safety and efficacy in chronic Hepatitis B. NCT02858401 and NCT03060447 assessed its safety and biological activity in HIV-1 infected adults. NCT05281510 studied it in early antiretroviral-treated HIV-1 clade C-infected women.
Vesatolimod is also known as GS-9620. It is an investigational TLR7 agonist being developed by Gilead Sciences for the treatment of chronic Hepatitis B and HIV-1 infection. The drug is currently in Phase 2 clinical development.