Standard DoseOne tablet once daily without regard to food. Tablet contains 100 mg of doravirine.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
ManufacturerMerck and Co.
Potential Side Effects and Toxicity
See package insert. In one study, side effects observed in 10% or more of 383 patients taking a regimen containing doravirine included nausea (11%), neuropsychiatric symptoms (11%, including depression, abnormal dreams, insomnia, and dizziness), diarrhea (14%), and headache (14%). Brain-related side effects (including dizziness, nightmares, and depression) were significantly less common in study participants taking doravirine than in those who received efavirenz.
Potential Drug Interactions
See package insert. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not. Do not take with any other HIV antiretroviral medication unless specifically instructed to do so by expert consultation. Therefore, do not take with the following HIV medications, since these are already in this drug or they have medication from similar drug classes: Atripla, Complera, Desltrigo, Edurant, Intelence, Juluca, Odefsey, or Sustiva.
Received FDA approval in 2018. Doravirine may be an option for patients who have developed drug resistance to other NNRTIs. A single-tablet regimen (STR) containing doravirine was also approved this year; see Delstrigo page. Doravirine was found to be non-inferior to boosted darunavir (brand name Prezista) at 48 weeks. Darunavir is one of two protease inhibitors recommended for first-time use in certain clinical situations by U.S. HIV treatment guidelines. Doravirine has not yet been compared to an integrase inhibitor (INSTI), all of which are DHHS recommended for most people taking HIV medication for the first time. Doravirine is a non-nucleoside medication, a drug class that includes rilpivirine (brand name Edurant, found in Complera and Odefsey).
In the DRIVE-FORWARD study, with people taking HIV therapy for the first time (treatment-naïve), there was a lower success rate than is expected in HIV therapy today. This was thought to be affected by the number of people who quickly dropped out of the study when given so many pills to take—they were not given a single-tablet regimen (STR). Those drop-outs were counted as virologic failures. The success rate was 80% for the darunavir group and 84% for the doravirine group (achieving undetectable viral loads of less than 50 copies per mL). Only one of 364 doravirine-treated patients developed drug resistance, a relatively low number for an NNRTI; there was no resistance in the boosted darunavir group (as could be expected). The doravirine STR is being studied in treatment-naïve individuals (first time on HIV therapy) who have virus that doesn’t respond well to other NNRTIs (the DRIVE BEYOND study). It is also being studied in people with undetectable viral loads on their current treatment who are switched to the doravirine STR (the Phase 3 DRIVE-SHIFT study).
See package insert for more complete information on potential side effects and interactions.
Pifeltro (doravirine) is considered a “second generation” NNRTI due because of its enhanced resistance profile compared to Sustiva and other older “first generation” NNRTIs. In fact, lab studies predict that it may be effective after a first generation NNRTI has failed and left HIV resistance mutations. To date, data from two large clinical trials comparing doravirine to Sustiva and to Prezista/Norvir have shown that doravirine has similar anti-HIV potency as those two known potent medications and with fewer side effects. Doravirine was also developed as an STR combined with Viread and Epivir (Delstrigo).
This new drug is effective against NNRTI drug-resistant mutations. Individuals with resistance to other NNRTIs may benefit from regimens containing doravirine. It is also contained in the new single-tablet regimen doravirine/TDF/3TC (Delstrigo). The potency of doravirine is comparable to efavirenz and boosted darunavir when used in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-naïve individuals. Brain and central nervous system side effects are less common in individuals taking doravirine compared to those taking efavirenz. Doravirine was approved in 2018 by the FDA.