Prescription medicine
Doravirine and lamivudine and tenofovir disoproxil Brand names: Delstrigo
Doravirine and lamivudine and tenofovir disoproxil (Delstrigo) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $93.06 per Delstrigo 100-300-300 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the doravirine and lamivudine and tenofovir disoproxil FDA label on DailyMed (effective July 8, 2026, Merck Sharp & Dohme LLC); the NDA 210807 record on Drugs@FDA; every doravirine and lamivudine and tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of July 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DELSTRIGO. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2) ]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of DELSTRIGO. Closely monitor hepatic function in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageDELSTRIGO ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions a
Forms and strengths
- 100 mg / 300 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 30, 2018 Delstrigo, Msd Merck Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 29, 2036 Delstrigo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $93.06 per tablet Delstrigo 100-300-300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 301 through July 30, 2026
What is doravirine and lamivudine and tenofovir disoproxil used for?
From the label: indications and usageDELSTRIGO ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO [see Clinical Studies (14) ]. […]
Conditions named in the indications of doravirine and lamivudine and tenofovir disoproxil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (DELSTRIGO), Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set cd1e9f84-607a-46d3-b01e-2736018d67b6), via openFDA; the full label on DailyMed
What does the patient leaflet for doravirine and lamivudine and tenofovir disoproxil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DELSTRIGO?DELSTRIGO can cause serious side effects, including: Worsening of hepatitis B virus infection (HBV). If you have Human Immunodeficiency Virus-1 (HIV-1) and HBV infection, your HBV infection may get worse (flare-up) if you stop taking DELSTRIGO. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with DELSTRIGO. Do not run out of DELSTRIGO. Refill your prescription or talk to your healthcare provider before your DELSTRIGO is all gone. Do not stop taking DELSTRIGO without first talking to your healthcare provider. If you stop taking DELSTRIGO, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DELSTRIGO. For more information about side effects, see " What are the possible side effects of DELSTRIGO? " What is DELSTRIGO? DELSTRIGO is a prescription medicine that is used without other HIV-1 medicine to treat HIV-1 infection in adults and children who weigh at least 77 pounds (35 kg): who have not received HIV-1 medicine in the past, or to replace their current HIV-1 medicine for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). DELSTRIGO contains the prescription medicines doravirine, lamivudine and tenofovir disoproxil fumarate. It is not known if DELSTRIGO is safe and effective in children who weigh less than 77 pounds (35 kg). […]
From the patient leaflet: How should I store DELSTRIGO?Store DELSTRIGO tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep DELSTRIGO in the original bottle. Do not take the tablets out of the bottle to store in another container, such as a pill box. Keep the bottle tightly closed to protect DELSTRIGO from moisture. The DELSTRIGO bottle contains desiccants to help keep your medicine dry (protect it from moisture). Keep the desiccants in the bottle. Do not eat the desiccants. Keep DELSTRIGO and all medicines out of the reach of children.
Source: FDA drug label (DELSTRIGO), Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set cd1e9f84-607a-46d3-b01e-2736018d67b6), via openFDA; the full label on DailyMed
Is there a generic for doravirine and lamivudine and tenofovir disoproxil (Delstrigo)?
No generic doravirine and lamivudine and tenofovir disoproxil is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Delstrigo tablets: the compound patent runs to August 30, 2032, and the last listed entry to November 29, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for doravirine and lamivudine and tenofovir disoproxil (Delstrigo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $93.06 per Delstrigo 100-300-300 mg tablet, up 3% from $90.68 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Delstrigo 100-300-300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Delstrigo 100-300-300 mg tablet | Brand | $93.06 per tablet | $2,791.82 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the doravirine and lamivudine and tenofovir disoproxil label say about other medicines?
The doravirine and lamivudine and tenofovir disoproxil label names 29 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ]. |
| Atorvastatin | drug interactions | No clinically significant changes in concentration were observed for the following agents when co-administered with doravirine: lamivudine, TDF, elbasvir and grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, or midazolam. |
| Carbamazepine | contraindications | These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. … |
| Cidofovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ]. |
| Entecavir | drug interactions | No clinically significant changes in concentration were observed for tenofovir when co-administered with tacrolimus or entecavir [see Clinical Pharmacology (12.3) ]. |
| Enzalutamide | contraindications | These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. … |
| Ganciclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ]. |
| Gentamicin | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, or methadone [see Clinical Pharmacology (12.3) ]. |
| Ledipasvir and sofosbuvir | drug interactions | Drug Interactions with DELSTRIGO This table is not all-inclusive Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment ↑ = increase, ↓ = decrease All other drug-drug interactions shown are anticipated based on the known metabolic and elimination pathways. … |
| Levonorgestrel | drug interactions | No clinically significant changes in concentration were observed for the following agents when co-administered with doravirine: lamivudine, TDF, elbasvir and grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, or midazolam. |
| Magnesium hydroxide | drug interactions | TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, or methadone [see Clinical Pharmacology (12.3) ]. |
| Metformin | drug interactions | No clinically significant changes in concentration were observed for the following agents when co-administered with doravirine: lamivudine, TDF, elbasvir and grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, or midazolam. |
| Methadone | drug interactions | No clinically significant changes in concentration were observed for the following agents when co-administered with doravirine: lamivudine, TDF, elbasvir and grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, or midazolam. |
Every other medicine the doravirine and lamivudine and tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Midazolam | drug interactions | … containing ethinyl estradiol and levonorgestrel, metformin, methadone, or midazolam. |
| Mitotane | contraindications | … the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. John's wort ( Hypericum perforatum) DELSTRIGO is contraindicated in patients with a previous hypersensitivity … |
| Oxcarbazepine | contraindications | These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the … |
| Pantoprazole | drug interactions | … aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, or methadone [see Clinical Pharmacology (12.3) ]. |
| Phenobarbital | contraindications | These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the … |
| Phenytoin | contraindications | These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: rifabutin; Effect on Concentration: ↓ doravirine; Clinical Comment: If DELSTRIGO is co-administered with rifabutin, one tablet of doravirine (PIFELTRO) should be … |
| Rifampin | contraindications | … androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. … |
| Rifapentine | contraindications | … receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. John's wort ( Hypericum perforatum) DELSTRIGO is contraindicated in patients with a … |
| Ritonavir | drug interactions | TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, or methadone [see … |
| Sofosbuvir | drug interactions | Concomitant Drug Class/Drug Name: ledipasvir/sofosbuvir sofosbuvir/velpatasvir; Effect on Concentration: ↑ tenofovir; Clinical Comment: Monitor for adverse reactions associated with TDF. |
| Sofosbuvir and velpatasvir | drug interactions | Drug Interactions with DELSTRIGO This table is not all-inclusive Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment ↑ = increase, ↓ = decrease All other drug-drug interactions … |
| Tacrolimus | drug interactions | No clinically significant changes in concentration were observed for tenofovir when co-administered with tacrolimus or entecavir [see Clinical Pharmacology (12.3) ]. |
| Valacyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Valganciclovir | drug interactions | … are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) and … |
Check doravirine and lamivudine and tenofovir disoproxil against other medicines
Source: FDA drug label (DELSTRIGO), Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set cd1e9f84-607a-46d3-b01e-2736018d67b6), via openFDA; the full label on DailyMed
What do FAERS reports show for doravirine and lamivudine and tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 301 reports that list doravirine and lamivudine and tenofovir disoproxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 68 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as doravirine and lamivudine and tenofovir disoproxil?
29 other medicines are given the same way (oral) and in the same FDA class as doravirine and lamivudine and tenofovir disoproxil or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 mg tablet | No current entry |
| Efavirenz | HIV | 5 labelers | $1.28 per tablet 600 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
| Rilpivirine | HIV | 2 labelers | $48.04 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as doravirine and lamivudine and tenofovir disoproxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to doravirine and lamivudine and tenofovir disoproxil
- 29 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Doravirine and lamivudine and tenofovir disoproxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other