This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.
This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

Doravirinesafety information: adverse events

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Doravirine/3TC/TDF = DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)

144-week results of DRIVE-SHIFT1

Most common adverse events of any causality through to Week 1441

Drive Shift logo
Nasopharyngitis 16.2%
Headache 12.3%
Diarrhoea 9.1%

Adapted from Kumar P et al. 20211

These events were rated as mild intensity by 73.6% (nasopharyngitis), 74.1% (headache) and 75% (diarrhoea) of participants.1

Overall 4.1% participants discontinued due to adverse events through to Week 144.1

96-week results of DRIVE-AHEAD2 and DRIVE-FORWARD3

Summary of all cause adverse events with ≥10% incidence in either treatment group through Week 96 in DRIVE-AHEAD2

AEs DOR/3TC/TDF (n=364) EFV/FTC/TDF (n=364)
Neuropsychiatric AE (prespecified)a 26% 59%
Adverse eventb
Headache 16% 15%
Nasopharyngitis 14% 12%
Diarrhoea 13% 16%
Upper respiratory tract infection 11% 8%
Dizziness 10% 38%
Nausea 9% 12%
Insomnia 7% 10%
Rash 6% 12%
Abnormal dreams 5% 12%

aPrespecified AEs included dizziness, sleep disorders and disturbances. altered sensorium, depression and suicide/self-injury, and psychosis and psychotic disorders
bAEs with ≥10% incidence in either treatment group
3TC = lamivudine; AE = Adverse Event; DOR = doravirine; EFV = efavirenz; FTC = emtricitabine; TDF = tenofovir disoproxil fumarate.

Proportion of participants with neuropsychiatric adverse events in prespecified categories through Week 96 in DRIVE-AHEAD2

Neuropsychiatric Adverse Events

3TC = lamivudine; AE = Adverse Event; DOR = doravirine; EFV = efavirenz; FTC = emtricitabine; TDF = tenofovir disoproxil fumarate.

Drive shift logo

Consistent with results from weeks 0–48,4 overall neuropsychiatric AEs (weeks 0–96) were less common for DOR/3TC/TDF (26.4%) than for EFV/FTC/ TDF (58.5%).2

The majority of reported neuropsychiatric AEs occurred before week 48 for both groups, with minimal difference in new-onset neuropsychiatric AEs between groups after week 48.2

3TC = lamivudine; DOR = doravirine; EFV = efavirenz; FTC = emtricitabine; TDF = tenofovir disoproxil fumarate

Summary of all cause adverse events with ≥5% incidence in either treatment group through Week 96 in DRIVE-FORWARD3

  PIFELTRO + 2 NRTIs once daily (n=383) DRV/r + 2 NRTIs once daily (n=383)
Adverse eventa
Abdominal pain upper 5% 3%
Back pain 7% 3%
Bronchitis 6% 8%
Cough 6% 3%
Diarrhoea 17% 24%
Dizziness 5% 5%
Fatigue 9% 6%
Headache 15% 12%
Insomnia 5% 5%
Nausea 12% 14%
Syphilis 6% 6%
Upper respiratory tract infection 13% 8%
Viral upper respiratory tract infection 11% 13%

aAEs with ≥5% incidence in either treatment group.
NRTI = Nucleoside Reverse Transcriptase Inhibitor; DRV/r = darunavir/ritonavir.

Neuropsychiatric adverse events through week 48 in DRIVE-FORWARD5

This was an interim analysis only completed in the initial study and reported in the week 48 publication

PIFELTRO + NRTIs once daily (n=383) 11%
DRV/r + NRTIs once daily (n=383) 13%

Neuropsychiatric events in the DRIVE-FORWARD study include disturbances in attention, dizziness, somnolence, abnormal dreams, confusion, depressed mood, depression, insomnia, major depression, nightmares, and psychotic disorder. No participants discontinued study treatment due to neuropsychiatric adverse events.

Please refer to the relevant Summary of Product Characteristics for full details of adverse events and contraindications before prescribing.

Precautions6,7
Contraindications6,7

References

  1. Kumar P et al. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2021 Feb 17. doi: 10.1097/QAI.0000000000002642. Epub ahead of print.
  2. Orkin C et al. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double blind, Phase 3 DRIVE-AHEAD Noninferiority Trial. Clinical Infectious Diseases. 2020: 1-10.
  3. Molina JM et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD):96-week results of a randomised, double-blind, non-inferiority, phase 3 trial. Lancet HIV. 2020;7: 16-26.
  4. Orkin C et al. Doravirine/lamivudine/tenofovir disoproxil fumarate is non-inferior to efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults with human immunodeficiency virus-1 infection: week 48 results of the DRIVE-AHEAD trial. Clin Infect Dis. 2019;68(4):535-544.
  5. Molina JM et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018;5:e211-e220.
  6. DELSTRIGO Summary of Product Characteristics.
  7. PIFELTRO Summary of Product Characteristics.

Supporting documentation

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-DOV-00020 | Date of Preparation: May 2021