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Also known as Doravirine
Doravirine+ tenofovir DF+ lamivudine · 1 trial · 1 indication
The non-inferiority will be assessed in terms of virologic efficacy at week 48 under allocated treatment using the FDA snapshot algorithm (window period of 42-54 weeks), and measured by the proportion of subjects achieving a rate of HIV 1 RNA \<50 copies/mL, in HIV-1 infected, treatment-naive subjects with pre-treatment viral load (HIV-1 RNA) ≥ 1,000 copies/mL. The rate of HIV 1 RNA will be measured by RT-PCR.
| Arm | Type | Description |
|---|---|---|
| Doravirine arm | EXPERIMENTAL | Doravirine (100 mg) + tenofovir DF (300 mg) + lamivudine (300mg) administered daily |
| Dolutegravir arm | ACTIVE_COMPARATOR | Dolutegravir (50 mg) + tenofovir DF 300 mg + XTC (300 mg if lamivudine or 200 mg if emtricitabine) administered daily |
| Name | Type | Description |
|---|---|---|
| Doravirine + tenofovir DF + lamivudine | DRUG | Oral administration |
| Dolutegravir + tenofovir DF + lamivudine or emtricitabine | DRUG | Oral administration |
Inclusion Criteria: * Be at least 18 years of age on the day of signing the informed consent. * Be HIV-1 positive as determined according to national testing strategies * Have a plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to the randomization, * Have HIV treatment indication based on phys...
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Doravirine is an investigational small molecule being studied for the treatment of HIV-1 infection, including in patients with renal impairment. It is being developed as a single agent and in combination with tenofovir DF and lamivudine for virologically suppressed HIV-1-infected adults.
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that targets the reverse transcriptase enzyme of HIV-1. By inhibiting this enzyme, it interferes with viral replication. The drug is being studied in combination with other antiretrovirals to maintain viral suppression in HIV-1-infected patients.
Doravirine is being developed by Merck & Company, Inc. (NYSE: MRK). The company is conducting clinical trials to evaluate the drug's safety and efficacy in HIV-1-infected participants, including those switching from other antiretroviral regimens.
Doravirine is in Phase 2 clinical development. While some completed trials were Phase 1 and Phase 3, the most recent completed trial was a Phase 2 study evaluating a switch to doravirine, tenofovir, and lamivudine in virologically suppressed participants.
Doravirine has been studied in several clinical trials, including NCT01466985, a Phase 1 study in HIV-1-infected participants; NCT02089659, a Phase 1 hepatic impairment study; NCT02397096, a Phase 3 switch study; and NCT02652260, a Phase 2 switch study from efavirenz-based therapy.
Doravirine is the single-agent form, while doravirine plus tenofovir DF and lamivudine is a fixed-dose combination being studied under the code MK-1439A. Clinical trials have evaluated both the single agent and the combination in HIV-1-infected patients.