NRTI/NRTI/NNRTI single-tablet regimen Pregnancy: eMC §4.6: as a precautionary measure, it is preferable to avoid the use of Delstrigo during pregnancy. There are no or limited data on doravirine in pregnant women; a large amount of data (more than 3000 first-trimester outcomes) on lamivudine with other antiretrovirals indicates no malformative toxicity, and a moderate amount of data (300-1000 outcomes) indicates no malformations or foetal/neonatal toxicity with tenofovir disoproxil. Physicians are encouraged to register patients in the Antiretroviral Pregnancy Registry. It is recommended that women living with HIV do not breast-feed, in order to avoid transmission of HIV.

Lamivudine with tenofovir disoproxil and doravirine

Brand names: Delstrigo

This is a fixed-dose oral combination of lamivudine and tenofovir disoproxil (two nucleos(t)ide reverse transcriptase inhibitors) with the non-nucleoside reverse transcriptase inhibitor doravirine, used as a complete single-tablet regimen for HIV-1 infection in suitable adults.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet (doravirine 100 mg / lamivudine 300 mg / tenofovir disoproxil 245 mg) once daily

Route: Oral - swallowed whole, with or without food

Frequency: Once daily

eMC §4.2 (Delstrigo 100 mg/300 mg/245 mg film-coated tablets). Therapy should be initiated by a physician experienced in the management of HIV infection. DOSE ADJUSTMENT: if co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily, achieved by adding one 100 mg tablet of doravirine (as a single agent) taken approximately 12 hours apart from the Delstrigo dose. Co-administration with other moderate CYP3A inducers has not been evaluated but decreased doravirine concentrations are expected; if co-administration with other moderate CYP3A inducers (e.g. dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg doravirine tablet should be taken daily, approximately 12 hours after the Delstrigo dose. MISSED DOSE: if missed within 12 hours of the usual time, take as soon as possible and resume the normal schedule; if missed by more than 12 hours, skip it and take the next dose at the regularly scheduled time - do not take 2 doses at one time. ELDERLY: limited data in patients aged 65 years and over; no evidence a different dose is required, but special care is advised because of age-associated decreases in renal function. HEPATIC IMPAIRMENT: no dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; doravirine has not been studied in severe impairment (Child-Pugh C), so caution is advised. SAFETY (§4.4): severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported post-marketing with doravirine-containing regimens - withdraw immediately if suggestive signs or symptoms appear and never restart after a serious reaction such as TEN. All patients should be tested for hepatitis B before starting antiretroviral therapy; severe acute exacerbations of hepatitis B have been reported in HIV-1/HBV co-infected patients who discontinued lamivudine or tenofovir disoproxil, so monitor clinically and with laboratory follow-up for at least several months after stopping. PAEDIATRIC: safety and efficacy in children aged less than 12 years or weighing less than 35 kg have not been established and no data are available - verify any such use against a children's formulary.

Dose adjustments

Renal

eMC §4.2: no dose adjustment is required if estimated creatinine clearance is 50 mL/min or greater. Delstrigo should not be initiated if estimated CrCl is below 50 mL/min and should be discontinued if estimated CrCl declines below 50 mL/min. Patients with moderate or severe renal impairment require a dose-interval adjustment of lamivudine and tenofovir disoproxil that cannot be achieved with the combination tablet.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients (eMC §4.3)
Co-administration with strong cytochrome P450 CYP3A enzyme inducers, because significant decreases in doravirine plasma concentrations are expected and may reduce effectiveness (eMC §4.3). These include, but are not limited to: carbamazepine, oxcarbazepine, phenobarbital, phenytoin; rifampicin, rifapentine; St John's wort (Hypericum perforatum); mitotane; enzalutamide; lumacaftor

Side effects

Nausea (4%) - common, together with diarrhoea, abdominal pain, vomiting and flatulence
Headache (3%), dizziness and somnolence - common; abnormal dreams and insomnia - common; nightmare, depression, anxiety, irritability, confusional state and suicidal ideation - uncommon
Rash and alopecia - common; toxic epidermal necrolysis - frequency not known (severe cutaneous adverse reactions including SJS/TEN reported post-marketing, see §4.4)
Renal: increased creatinine and proximal renal tubulopathy including Fanconi syndrome - uncommon; acute kidney injury, acute renal failure, acute tubular necrosis, nephritis and nephrogenic diabetes insipidus - rare
Musculoskeletal: muscle disorders and decreased bone mineral density - common; myalgia, arthralgia, rhabdomyolysis and muscular weakness - uncommon; osteomalacia and myopathy - rare
Metabolic/haematological: hypophosphataemia and hypokalaemia - uncommon; hypomagnesaemia and lactic acidosis - rare; neutropenia, anaemia and thrombocytopenia - uncommon; pure red cell aplasia - very rare

Interactions

Strong CYP3A inducers (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, St John's wort, mitotane, enzalutamide, lumacaftor) - co-administration is contraindicated (eMC §4.3)
Rifabutin (eMC §4.2) - increase the doravirine dose to 100 mg twice daily by adding a separate 100 mg doravirine tablet approximately 12 hours apart from the Delstrigo dose
Other moderate CYP3A inducers, e.g. dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl (eMC §4.2) - if unavoidable, add one 100 mg doravirine tablet daily approximately 12 hours after the Delstrigo dose
Nephrotoxic medicinal products, e.g. high-dose or multiple NSAIDs (eMC §4.4) - avoid concurrent or recent use; cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in HIV-infected patients
The full eMC §4.5 interaction section was not captured in this bundle - clinician to review it in the SPC

Clinical monograph

How it works

Lamivudine and tenofovir are phosphorylated and incorporated into viral DNA to terminate reverse transcription, while doravirine binds non-competitively to reverse transcriptase, inhibiting the enzyme at a separate allosteric site.

Prescribing in practice

Tenofovir disoproxil can cause renal impairment, including proximal tubulopathy, and reduced bone mineral density, so renal function and bone risk must be assessed before and during treatment.
Doravirine exposure is markedly reduced by strong CYP3A4 inducers such as rifampicin and certain anticonvulsants, which are contraindicated or require regimen review.
Both lamivudine and tenofovir are active against hepatitis B, so co-infection should be identified and discontinuation managed carefully to avoid a severe hepatitis flare.

Monitoring

Monitor HIV viral load and CD4 count alongside renal function, serum phosphate and hepatitis B status, with attention to bone health in those at risk.

Counselling the patient

Take the single daily tablet consistently to maintain viral suppression.
Avoid starting medicines or herbal products that may interact, and mention rifampicin or anti-seizure drugs to your team.
Report new bone pain, muscle weakness or symptoms suggesting kidney problems.

Evidence & guidelines

Doravirine-based regimens are supported by the DRIVE programme of trials and are recommended options within UK HIV treatment guidance.

Reference: BHIVA; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways