DOR/3TC/TDF doravirine/lamivudine/tenofovir disoproxil fumarate
Standard DoseOne tablet once daily without regard to food for people taking HIV treatment for the first time (treatment-naïve) or individuals with suppressed viral load on a stable HIV regimen for at least 6 months who have no known resistance to components of the regimen: doravirine, lamivudine, or tenofovir. Tablet contains 100 mg of the NNRTI doravirine plus 300 mg lamivudine and 300 mg tenofovir DF (TDF). Approved only for adults at this time.
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. Dose cannot be adjusted for people with kidney problems; Delstrigo is not recommended for people with estimated creatinine clearance less than 50 mL/min. Should not be used by people with moderate or severe kidney impairment or severe liver impairment.
- See the individual drugs contained in Delstrigo: Pifeltro, Viread, and Epivir.
- See package insert for more complete information on potential side effects and interactions.
ManufacturerMerck and Co.
delstrigo.com; (800) 672-6372
Potential Side Effects and Toxicity
The most common adverse reactions observed with Delstrigo in clinical trials were dizziness (7%), nausea (5%), abnormal dreams (5%), and headache (4%). Neuropsychiatric events—such as depression, sleep disturbances, dizziness, etc.—are another common side effect of the NNRTI drug class. The proportion of people who reported one or more neuropsychiatric adverse events overall was 24% for the Delstrigo group compared to 57% for the Atripla group in the DRIVE-AHEAD study. Neuropsychiatric adverse events associated with depression and suicide/self-injury were reported in 4% of the Delstrigo group compared to 7% of the Atripla group. Overall, sleep disturbances (e.g., abnormal dreams, insomnia, nightmares, etc.) were associated with 12% of people in the Delstrigo group compared to 26% of people in the Atripla group.
Dizziness was experienced by 9% of the Delstrigo group compared to 37% of the Atripla group. Altered sensorium (e.g., lethargy, drowsiness, etc.) was associated with 4% of people in the Delstrigo group compared to 8% of those on Atripla. The doravirine component of Delstrigo did not appear to negatively affect cholesterol in studied populations. Decreases in bone mineral density (BMD) have been observed in people on TDF-containing regimens. BMD monitoring should be considered for people who have a history of bone fracture due to bone disease or are at risk for osteopenia or osteoporosis. TDF may cause kidney toxicities. Creatinine clearance (CrCl) should be assessed before initiating treatment. In addition to CrCl, glucose and protein in the urine and serum phosphorus should be monitored more often in patients at risk for kidney problems.
Tell your provider about any pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits, as these could be signs of kidney problems. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Delstrigo (due to elimination of the lamivudine and TDF components, which also treat HBV). Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Delstrigo discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs.
Potential Drug Interactions
Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, all used for hepatitis B. When using with the antibiotic drug rifabutin (used for TB and to prevent MAC in AIDS patients), increase the doravirine dose by adding a Pifeltro 100 mg tablet approximately 12 hours later. Avoid taking Delstrigo with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain such as Advil or Motrin (ibuprofen) and Aleve (naproxen). The following medications may lower the blood levels of doravirine, and therefore may decrease its effectiveness, and should not be used with Delstrigo: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent (a cancer drug) mitotane; and the herbal St. John’s wort.
Avoid use of sorbitol-containing medicines with lamivudine; there are many, such as acetaminophen liquid (Tylenol liquid and others). Epclusa and Harvoni each increase the concentration of TDF; monitor for adverse reactions. Not intended to be taken with other HIV medications, unless prescribed that way. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Stand-alone versions of doravirine (Pifeltro) and lamivudine/tenofovir DF (Cimduo, Temixys) are also approved; see those pages. Unfortunately, Delstrigo contains an older prodrug of tenofovir, TDF. A safer version, TAF, is available and used in some STRs. Ironically, however, as TAF and INSTIs may have some association with weight gain, Delstrigo may become a more popular option. (See Tivicay; also, go to positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues.) TDF is still an effective and quite tolerable medication, but TAF has potentially less long-term renal and bone toxicity. Doravirine has not been directly compared to integrase inhibitor-based regimens in clinical trials yet. For individuals with HIV-2, commonly found outside the U.S., an NNRTI would not be recommended as HIV-2 is inherently resistant to NNRTIs. There are no data on the safe use of Delstrigo during pregnancy.
In the DRIVE-FORWARD study comparing doravirine to darunavir, at 96 weeks, 72% of treatment-naïve individuals in the doravirine group attained undetectable status (a viral load of less than 50 copies/mL), compared to 65% for the darunavir group.
Dr. Melanie Thompson:
Delstrigo is an STR containing doravirine (DOR), the newest NNRTI, as well as generic 3TC and TDF. DOR has not been compared directly with any INSTI-containing regimens, therefore it is not a recommended option for most people starting therapy according to DHHS and IAS-USA guidelines. It is, however, recommended “in certain situations” when an INSTI can’t be used. Finding a niche for an NNRTI-based regimen is a bit of a challenge these days. Delstrigo was found to be non-inferior to efavirenz, which now is rarely prescribed to anyone who is not still clinging to their Atripla, but DOR + nukes also was non-inferior to ritonavir-boosted darunavir. It could possibly be an option for people on a boosted PI regimen without substantial viral resistance to NNRTIs and NRTIs and who could benefit from getting away from a boosted regimen.
Delstrigo is well tolerated and DOR has the advantage of having fewer and less severe central nervous system side effects than efavirenz. It also has no food requirements.
An analysis of weight gain on DOR-containing regimens found no difference between DOR, ritonavir-boosted darunavir, and efavirenz after nearly 2 years.
Delstrigo should not be prescribed to anyone who is pregnant as there are insufficient data on pregnancy.
The inclusion of generic drugs allows Delstrigo to be priced lower than other three- or four-drug STRs, although one can certainly argue that the price could be substantially lower because of the generic components.
Activist Bridgette Picou:
Delstrigo can be taken with or without regard to food. When taking Delstrigo, you should be tested for hepatitis B virus (HBV). While having HBV does not preclude you from taking the medication, you need to know your status so that you do not suddenly stop taking it, as this can cause a flare in your HBV. Take missed doses as soon as possible, as with all HIV meds, and do not double up on missed ones. Should you find yourself running low or know you may be without medication, speak with your clinician or a case management specialist for options.