Doravirine, Lamivudine, and Tenofovir
Doravirine, lamivudine, and tenofovir are three antiviral ingredients combined in Delstrigo to treat HIV-1 infection in adults and eligible pediatric patients.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important warning for people with both HIV and hepatitis B: If you have HIV and hepatitis B at the same time, stopping Delstrigo can cause a sudden, severe worsening of your hepatitis B infection. This can be life-threatening — in some cases leading to liver failure. If you need to stop Delstrigo for any reason, your doctor must monitor your liver function closely with blood tests for at least several months after you stop. Anti-hepatitis B treatment may need to be started to protect your liver, especially if you already have advanced liver disease.
📖 Doravirine, Lamivudine, and Tenofovir: Patient Information Guide
A plain-language walkthrough of Doravirine, Lamivudine, and Tenofovir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Doravirine, lamivudine, and tenofovir together form a complete HIV treatment regimen. Here is the full set of approved uses:
- Delstrigo (oral tablet): treats HIV-1 infection in adults and pediatric patients weighing at least 35 kg who have never taken HIV medicines before
- Delstrigo (oral tablet): replaces a current HIV regimen in adults and eligible pediatric patients whose HIV is already suppressed (viral load below 50 copies/mL), as long as there has been no treatment failure and no known resistance to doravirine, lamivudine, or tenofovir
⚙️How it works▾
HIV needs an enzyme called reverse transcriptase to make copies of itself inside your cells. All three ingredients in Delstrigo attack this enzyme, but in different ways. Doravirine is an NNRTI (non-nucleoside reverse transcriptase inhibitor) — it binds directly to the enzyme and blocks it. Lamivudine and tenofovir disoproxil fumarate are NRTIs (nucleoside/nucleotide analogues) — they mimic the building blocks HIV uses and get inserted into the viral genetic code, jamming the copying machine. Hitting reverse transcriptase from two angles at once makes it much harder for HIV to reproduce and develop resistance.
💊How it's taken▾
Delstrigo is taken as one tablet by mouth once a day. It can be taken with or without food — eating does not meaningfully change how the drug is absorbed. If you are also taking rifabutin, your prescriber will instruct you to take an additional doravirine tablet (Pifeltro) about 12 hours after your Delstrigo dose for as long as you take rifabutin.
- Take it at the same time each day to keep levels steady
- Do not stop taking it without talking to your doctor first — especially if you also have hepatitis B
- Delstrigo is not recommended in patients whose kidney function (creatinine clearance) is below 50 mL/min
🤒Side effects — in detail▾
Most people tolerate Delstrigo well — the majority of reported side effects were mild (Grade 1). The most common ones include:
- Dizziness
- Nausea
- Abnormal or unusual dreams
- Headache
- Insomnia (trouble sleeping)
- Diarrhea
- Drowsiness
Serious reactions are less common but require prompt medical attention: severe skin reactions (blistering, peeling, or rash with fever and organ symptoms), signs of kidney damage (bone pain, muscle weakness, decreased urination), and a hepatitis B flare if treatment is stopped. Call your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Hepatitis B flare after stopping: If you have both HIV and hepatitis B, stopping Delstrigo can trigger a sudden, severe worsening of hepatitis B — including liver failure. Never stop without medical supervision, and get liver monitoring for months afterward.
- Kidney damage: The tenofovir component can harm the kidneys, including causing Fanconi syndrome (a tubular injury that leaks important minerals). Kidney labs must be checked before and during treatment. Delstrigo should not be used with other kidney-stressing drugs.
- Severe skin reactions: Rare but serious skin reactions including Stevens-Johnson syndrome and DRESS syndrome have been reported. Stop Delstrigo immediately if you develop a painful or blistering rash, mouth sores, or rash with fever or swollen glands.
- Bone loss: Tenofovir is associated with reduced bone density and, rarely, bone softening (osteomalacia). Patients with fracture history or osteoporosis risk may need bone density monitoring.
- Immune reconstitution syndrome: When your immune system rebounds on HIV treatment, it can react to hidden infections or cause autoimmune flares. Report any new or unexpected symptoms after starting treatment.
🔀What it interacts with▾
Delstrigo has several important drug interactions — some are contraindicated, meaning they must never be combined:
- Strong CYP3A inducers (contraindicated): carbamazepine, oxcarbazepine, phenobarbital, phenytoin (seizure medicines); rifampin, rifapentine (TB antibiotics); enzalutamide (prostate cancer); mitotane (cancer); St. John's wort (herbal) — all drastically lower doravirine levels and make Delstrigo ineffective
- Rifabutin: lowers doravirine levels but is not contraindicated — requires adding an extra doravirine dose (Pifeltro) roughly 12 hours after Delstrigo
- Certain hepatitis C antivirals (ledipasvir/sofosbuvir, sofosbuvir/velpatasvir): raise tenofovir levels — monitor for kidney side effects
- Sorbitol-containing medicines: reduce lamivudine absorption — avoid combining when possible
- NSAIDs and nephrotoxic drugs: increase the risk of kidney damage when combined with tenofovir — consider alternatives if you're at kidney risk
- Drugs eliminated by the kidneys (e.g., acyclovir, ganciclovir, aminoglycoside antibiotics): can compete with lamivudine and tenofovir for kidney clearance, raising levels of all involved
- Other HIV medicines: Delstrigo is a complete regimen — adding other antiretrovirals is not recommended without specific guidance
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B co-infection: Test for HBV before starting. If you have both HIV and hepatitis B, stopping Delstrigo carries serious risk — your care team must manage this carefully.
- Kidney disease: Delstrigo is not recommended if your estimated creatinine clearance is below 50 mL/min. Kidney labs should be checked before and regularly during treatment.
- Severe liver disease: Delstrigo has not been studied in severe hepatic impairment (Child-Pugh Class C) — use with caution and discuss with your doctor.
- Pregnancy: Doravirine use in pregnancy has not been fully evaluated. Available registry data show no increased birth defect rate for lamivudine or tenofovir, but risks are still being tracked. Enroll in the Antiretroviral Pregnancy Registry if you become pregnant (1-800-258-4263).
- Breastfeeding: Not recommended — HIV can be passed through breast milk, and the drug components are present in milk.
- Children under 35 kg: Safety and efficacy have not been established; Delstrigo is not recommended.
- Older adults: Use with extra caution — age-related declines in kidney, liver, and heart function can affect drug levels.
- Previous allergic reaction to lamivudine: Delstrigo is contraindicated.
- Bone fracture history or osteoporosis risk: Consider bone density monitoring, as tenofovir can reduce bone mineral density.
🚑If you take too much▾
There is no specific antidote if someone takes too much Delstrigo. If an overdose occurs, the person should be monitored and treated supportively based on their symptoms. Tenofovir can be partially removed by hemodialysis (dialysis), but only a small portion of lamivudine is removed this way — and there is limited information on doravirine in overdose.
📡Pharmacodynamics — effects in the body▾
Doravirine does not meaningfully affect the heart's electrical rhythm (QT interval) even at doses much higher than those used in treatment. In clinical trials, no clear relationship was found between doravirine blood levels and how well it worked — suggesting the recommended dose is reliably effective across a range of patient sizes and exposures.
🔬Pharmacokinetics — how your body processes it▾
After taking one Delstrigo tablet, all three ingredients are absorbed into the bloodstream — food does not significantly change how much is absorbed, so it can be taken with or without a meal. Doravirine reaches peak blood levels in about 2 hours and is about 76% bound to proteins in the blood; it is primarily broken down by the liver enzyme CYP3A. Lamivudine is well absorbed (about 86% bioavailability) and is mainly cleared by the kidneys. Tenofovir has lower oral absorption (about 25%) and is also primarily eliminated by the kidneys — which is why reduced kidney function significantly raises tenofovir and lamivudine levels and makes Delstrigo unsuitable for patients with substantially impaired kidney function.
📦How to store it▾
Store DELSTRIGO in the original bottle. protect from moisture. Store DELSTRIGO at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Doravirine, Lamivudine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Doravirine, Lamivudine, and Tenofovir
145 supplements and herbal products have documented interactions with Doravirine, Lamivudine, and Tenofovir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 98
- Minor · 42
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Doravirine, Lamivudine, and Tenofovir — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Delstrigo and why has my doctor prescribed it? ▾
Does it matter if I take Delstrigo with food or on an empty stomach? ▾
What side effects should I expect, and which ones should make me call my doctor? ▾
I also have hepatitis B. Is there anything I need to know? ▾
Are there any medicines or supplements I need to avoid while taking Delstrigo? ▾
Is it safe to take Delstrigo if I'm pregnant or trying to become pregnant? ▾
Is Doravirine, Lamivudine, and Tenofovir available over the counter? ▾
When was Doravirine, Lamivudine, and Tenofovir first available? ▾
Who makes Doravirine, Lamivudine, and Tenofovir? ▾
💬 Answers drafted from Doravirine, Lamivudine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Doravirine, Lamivudine, and Tenofovir comes
Doravirine, Lamivudine, and Tenofovir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Delstrigo is used as a complete once-daily oral regimen for treating HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior HIV treatment history
- Delstrigo is used to replace a current HIV regimen in adults and eligible pediatric patients whose virus is already well controlled on a stable antiretroviral regimen with no treatment failure history and no known resistance to its components
- Delstrigo: take one tablet by mouth once daily, with or without food
- Delstrigo: if also taking rifabutin, take one Delstrigo tablet once daily plus one additional doravirine tablet (Pifeltro) approximately 12 hours later — follow your prescriber's exact instructions
- Delstrigo: not recommended if your kidney creatinine clearance is below 50 mL/min
- Delstrigo: have kidney function labs (serum creatinine, creatinine clearance, urine glucose, urine protein) checked before starting and regularly during treatment
📊 Doravirine, Lamivudine, and Tenofovir across the U.S. market
How Doravirine, Lamivudine, and Tenofovir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Doravirine, Lamivudine, and Tenofovir is used
A general measure of how commonly Doravirine, Lamivudine, and Tenofovir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Doravirine, Lamivudine, and Tenofovir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Doravirine, Lamivudine, and Tenofovir prescribed? Of the 1,594 medications we measure, Doravirine, Lamivudine, and Tenofovir ranks #1,026 by Medicaid prescriptions — more than 36% of them.
Utilization by Doravirine, Lamivudine, and Tenofovir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Doravirine, Lamivudine, and Tenofovir products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 2 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doravirine, Lamivudine, and Tenofovir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Doravirine, Lamivudine, and Tenofovir NDCs with Medicaid activity.
🔍 Compare Doravirine, Lamivudine, and Tenofovir products
A representative set of FDA-listed product records for Doravirine, Lamivudine, and Tenofovir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| DORAVIRINE 100 mg/1; LAMIVUDINE 300 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| 100; 300; 300 mg/1; mg/1; mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| DORAVIRINE 100 mg/1; LAMIVUDINE 300 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | — | MSD International GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Doravirine, Lamivudine, and Tenofovir NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doravirine, Lamivudine, and Tenofovir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doravirine, Lamivudine, and Tenofovir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Doravirine, Lamivudine, and Tenofovir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Doravirine, Lamivudine, and Tenofovir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Doravirine, Lamivudine, and Tenofovir belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.