Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-8591A, DOR
Doravirine/Islatravir · 10 trials · 3 indications
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported.
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE is reported.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE is reported.
Percentage of participants with serious adverse events (SAEs)
Percentage of participants who discontinued study treatment due to an AE.
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The final analysis for this outcome is presented here.
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one AE up to Week 48 was reported. The final analysis for this outcome is presented here.
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE up to Week 48 were reported. The final analysis for this outcome is presented here.
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE was reported.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE was reported.
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The plasma AUC0-24 will be assessed.
The plasma Cmax will be assessed.
The plasma Tmax will be assessed.
The plasma t½ will be assessed.
The CL/F will be assessed.
The Vz/F will be assessed.
The percentage of participants with AE(s) will be assessed.
The percentage of participants discontinuing from therapy due to AE(s) will be assessed.
The AUC0-24 of ISL in plasma was determined at steady state.
The Tmax of ISL in plasma was determined at steady state.
The CL/F of ISL from plasma was determined at steady state.
The Vz/F of ISL was determined at steady state.
The AUC0-24 of ISL-TP in PBMCs was determined at steady state.
The Cmax of ISL-TP in PBMCs was determined at steady state.
The C24 of ISL-TP in PBMCs was determined at steady state.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| DOR/ISL | EXPERIMENTAL | Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first. |
| BIC/FTC/TAF | ACTIVE_COMPARATOR | Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks. |
| ART + DOR/ISL | ACTIVE_COMPARATOR | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
| DOR/ISL and Placebo to BIC/FTC/TAF | EXPERIMENTAL | Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). |
| BIC/FTC/TAF and Placebo to DOR/ISL | ACTIVE_COMPARATOR | Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). |
| MK-8591A | EXPERIMENTAL | Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks. |
| Group 1: doravirine/islatravir (DOR/ISL) | EXPERIMENTAL | Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168. |
| Group 2: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | ACTIVE_COMPARATOR | Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168. |
| Group 2: Baseline Antiretroviral Therapy (ART) | ACTIVE_COMPARATOR | Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks. |
| Name | Type | Description |
|---|---|---|
| DOR/ISL | DRUG | FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily |
| BIC/FTC/TAF | DRUG | Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth. |
| Placebo to DOR/ISL | DRUG | Placebo tablet matched to DOR/ISL tablet taken by mouth. |
| Placebo to BIC/FTC/TAF | DRUG | Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
| ART | DRUG | Standard of care ART, per approved product list, taken orally |
| MK-8591A | DRUG | FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks |
| Placebo to FDC DOR/ISL | DRUG | Placebo to FDC DOR/ISL in a single tablet taken orally, once daily |
Inclusion Criteria: * Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]). Exclusion Criteria: * Has...
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Doravirine/islatravir is an investigational combination treatment for HIV-1 infection in adults and, in a pediatric study, in participants under 18 years of age weighing at least 35 kg. It is being studied both in antiretroviral treatment-naive patients and as a switch option for people already virologically suppressed on antiretroviral therapy.
Doravirine/islatravir is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program, which includes Phase 3 studies in adults and a Phase 2 study in pediatric participants with HIV-1.
Doravirine/islatravir is in Phase 3 clinical development. It is investigational and has not been approved. The program includes Phase 3 trials in treatment-naive adults, in virologically suppressed adults switching therapy, and in participants who previously received doravirine/islatravir, plus a Phase 2 pediatric study.
The program includes NCT05705349 in antiretroviral treatment-naive adults, NCT05631093 in virologically suppressed adults switching therapy, NCT05766501 in participants who previously received doravirine/islatravir, and NCT07862569, a Phase 2 study in pediatric participants with HIV-1 who are under 18 years of age and weigh at least 35 kg.
Yes. Doravirine/islatravir is also known as MK-8591A, and the shorthand DOR/ISL is used in trial titles. The names MK-8591A, DOR/ISL, and doravirine/islatravir refer to the same Merck combination product under study for HIV-1 infection.
Across the six listed doravirine/islatravir trials, total enrollment is 4,245 participants. The Phase 3 studies are randomized, double-blind, and actively controlled, and four of the six trials are currently active, with two completed.