doravirine/lamivudine/tenofovir DF (Rx)

Brand and Other Names:Delstrigo
  • Print

Dosing & Uses


Dosage Forms & Strengths

doravirine/lamivudine/tenofovir DF


  • 100mg/300mg/300mg

HIV Infection

Indicated as a complete regimen for treatment of HIV-1 infection in adults

  • Without prior antiretroviral therapy (ART) treatment history, OR
  • To replace a current ART regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART regimen with no history of treatment failure and no known substitutions associated with resistance to the individual drug components

1 tablet PO qDay with or without food

Dosage Modifications

Renal impairment

  • Estimated CrCl <50 mL/min: Use not recommended (unable to adjust fixed-dose combination)

Hepatic impairment

  • Mild or moderate (Child-Pugh A or B): No dosage adjustment required
  • Severe (Child-Pugh C): Not studied

Coadministration with rifabutin

  • If coadministered with rifabutin, 1 tablet (ie, 100 mg) of doravirine (Pifeltro) should be taken ~12 hr after Delstrigo dose

Dosing Considerations


  • Obtain baseline test for hepatitis B virus (HBV) infection (see Black Box Warnings)
  • Patients with chronic kidney disease: Obtain baseline serum phosphorus and periodically assess during treatment
  • Obtain the following tests at baseline and periodically assess during treatment for all patients
    • Serum creatinine
    • Estimated CrCl
    • Urine glucose
    • Urine protein

<18 years: Safety and efficacy not established



Interaction Checker

and doravirine/lamivudine/tenofovir DF

No Results

     activity indicator 
    No Interactions Found
    Interactions Found


      Serious - Use Alternative

        Significant - Monitor Closely


            All Interactions Sort By:
             activity indicator 

            Adverse Effects


            Sleep disorders and disturbances (12%)


            Dizziness (9%)

            Nausea (7%)

            Headache (6%)

            Fatigue (6%)

            Diarrhea (5%)

            Abdominal pain (5%)

            Total bilirubin 1.1 to <1.6x ULN (5%)

            Altered sensorium (4%)

            AST 2.5 to <5x ULN (4%)

            Lipase 1.5 to <3x ULN (4%)

            Creatinine >1.3 to 1.8x ULN (3%)

            ALT 2.5 to <5x ULN (3%)

            Lipase ≥3x ULN (3%)

            Creatine kinase ≥10x ULN (3%)

            Rash (2%)

            Total bilirubin 1.6 to <2.6x ULN (2%)

            Creatinine >1.8x ULN (2%)

            Creatine kinase 6 to <10x ULN (2%)

            Abnormal dreams (1%)

            Insomnia (1%)

            ALT ≥5x ULN (1%)


            AST ≥5x ULN

            Alkaline phosphatase 2.5 to <5x ULN

            LDL cholesterol, fasted ≥190 mg/dL

            Triglycerides, fasted >500 mg/dL

            Postmarketing Reports


            • Body as a whole: Redistribution/accumulation of body fat
            • Endocrine and metabolic: Hyperglycemia
            • General: Weakness
            • Hemic and lymphatic: Anemia (eg, pure red cell aplasia and severe anemias progressing on therapy)
            • Hepatic and pancreatic: Lactic acidosis and hepatic steatosis, posttreatment exacerbations of hepatitis B
            • Hypersensitivity: Anaphylaxis, urticaria
            • Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis
            • Skin: Alopecia, pruritus

            Tenofovir DF

            • Immune system disorders: Allergic reaction, including angioedema
            • Metabolism and nutrition disorders: Lactic acidosis, hypokalemia, hypophosphatemia
            • Respiratory, thoracic, and mediastinal disorders: Dyspnea
            • Gastrointestinal disorders: Pancreatitis, increased amylase, abdominal pain
            • Hepatobiliary disorders: Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
            • Skin and SC tissue disorders: Rash
            • Musculoskeletal and connective tissue disorders: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
            • Renal and urinary disorders: Acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
            • General disorders and administration site conditions: Asthenia


            Black Box Warnings

            Test all patients for HBV before initiating ARTs

            Severe acute hepatitis B exacerbations reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir DF

            Monitor both clinical and laboratory values for several months after discontinuing Delstrigo in patients who are coinfected with HIV-1 and HBV

            If appropriate, initiate antihepatitis B therapy


            Hypersensitivity to lamivudine

            Strong CYP3A inducers

            • Doravirine is contraindicated with strong CYP3A inducers, which may decrease effectiveness
            • Strong CYP3A inducer examples
              • Anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
              • Antimycobacterials (eg, rifampin, rifapentine)
              • Enzalutamide
              • Mitotane
              • St. John’s wort (Hypericum perforatum)


            Severe acute exacerbations of hepatitis B (eg, liver decompensated, liver failure) reported in patients coinfected with HIV-1 and HBV and who have discontinued products containing lamivudine and/or tenofovir DF

            Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with tenofovir DF; avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs)

            Discontinue if CrCl declines below 50 mL/min

            Tenofovir DF associated with decreased bone mineral density (BMD) and increased biochemical markers of bone metabolism; consider assessing BMD in patients at risk

            Immune reconstitution syndrome reported with combination ART

            Autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) reported to occur in the setting of immune reconstitution; however, time to onset varies and can occur many months after initiation of treatment

            Drug interaction overview

            • Coadministration of doravirine with strong CYP3A inducers may decrease systemic exposure and lead to loss of therapeutic effect and possible HIV resistance
            • Since Delstrigo is a complete regimen for HIV-1 infection, coadministration with other antiretroviral medications for HIV-1 infection not recommended; information regarding potential drug-drug interactions with other antiretroviral medications is not provided



            Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263; pregnancy exposure registry monitors pregnancy outcomes in individuals exposed during pregnancy

            Data are not available to establish drug-associated risks to pregnancy outcomes

            Doravirine has not been evaluated in pregnancy; however, lamivudine and tenofovir DF use during pregnancy has been evaluated in a limited number of individuals reported to the APR; available data from the APR show no difference in the overall risk of major birth defects for lamivudine and TDF compared with the background rate for major birth defects of 2.7% in the US reference population


            The Centers for Disease Control and Prevention do not recommend HIV-infected women breastfeed their infants, owing to potential risk for postnatal transmission of HIV

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.



            Mechanism of Action

            Doravirine: Non-nucleoside reverse transcriptase inhibitor (NNRTI); inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase

            Lamivudine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation to active metabolite, inhibits HIV reverse transcriptase via DNA chain termination after incorporation

            Tenofovir DF: NRTI; following hydrolysis and subsequent phosphorylation, inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine 5′-triphosphate (ATP) and, after incorporation into DNA, by DNA chain termination



            • Doravirine: 64%
            • Lamivudine: 86%
            • Tenofovir AF: 25%

            Peak plasma time

            • Doravirine: 2 hr
            • Tenofovir AF: 1 hr

            Peak plasma concentration

            • Doravirine: 0.962 mcg/mL
            • Lamivudine: 2.04 mcg/mL
            • Tenofovir AF: 0.3 mcg/mL


            • Doravirine: 16.1 mcg·h/mL
            • Lamivudine: 8.87 mcg·h/mL
            • Tenofovir AF: 2.29 mcg·h/mL


            Protein bound

            • Doravirine: 76%
            • Lamivudine: <36%
            • Tenofovir AF: <0.7%


            • Doravirine: 60.5 L
            • Lamivudine: 1.3 L/kg
            • Tenofovir AF: 1.3 L/kg


            Doravirine: CYP3A (primary)

            Lamivudine: CYP3A (minor)

            Tenofovir AF: No CYP metabolism



            • Doravirine: 15 hr
            • Lamivudine: 5-7 hr
            • Tenofovir AF: 17 hr

            Renal clearance

            • Doravirine: 9.3 mL/min
            • Lamivudine: 199.7 mL/min
            • Tenofovir AF: 243.5 mL/min

            Total clearance

            • Doravirine: 106 mL/min
            • Lamivudine: 398.5 mL/min
            • Tenofovir AF: 1043.7 mL/min


            • Major elimination route
              • Doravirine: Metabolism
              • Lamivudine and tenofovir AF: Glomerular filtration and active tubular secretion
            • Urine (unchanged)
              • Doravirine: 6%
              • Lamivudine: 71%
              • Tenofovir AF: 70-80%
            • Biliary/fecal (unchanged)
              • Doravirine: Minor
              • Lamivudine and tenofovir AF: Not applicable


            Oral Administration

            Complete regimen for HIV in adults without prior ART treatment history; do not prescribe with other ARTs

            Instruct patient to take at a regularly scheduled time of the day

            May take with or without food

            Missed dose

            • If patient forgets dose, instruct them to take the missed dose right away, unless it is almost time for the next dose
            • If time nearer to next dose, advise not to take 2 doses at once and to take the next dose at the regularly scheduled time


            Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Store in original bottle

            Keep bottle tightly closed to protect from moisture; do not remove desiccants





            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient



            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient



            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.