Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Doravirine
Doravirine, Tenofovir, Lamivudine · 1 trial · 1 indication
The percentage of participants in each arm with HIV-1 RNA levels \<50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach in which all missing data are considered treatment failures, regardless of the reason.
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).
| Arm | Type | Description |
|---|---|---|
| Doravirine, Tenofovir, Lamivudine | EXPERIMENTAL | Treatment-naive HIV-infected participants will receive doravirine, tenofovir, lamivudine, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. |
| ATRIPLA™ | ACTIVE_COMPARATOR | Treatment-naive HIV-infected participants will receive ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to doravirine, tenofovir, lamivudine q.d. by mouth for 96 weeks in order to maintain blinding. |
| Name | Type | Description |
|---|---|---|
| Doravirine, Tenofovir, Lamivudine | DRUG | One doravirine, tenofovir, lamivudine tablet taken q.d. by mouth. |
| ATRIPLA™ | DRUG | One ATRIPLA™ tablet taken q.d. by mouth |
| Placebo | DRUG | Placebo tablets matched to ATRIPLA® or Doravirine, Tenofovir, Lamivudine. |
Inclusion Criteria: * Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and has HIV treatment indicated based on physician as...
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.