Dolutegravir/lamivudine/tenofovir

Dolutegravir/lamivudine/tenofovir (DTG/3TC/TDF) is a medication used to treat HIV/AIDS.[1] It is a combination of dolutegravir, lamivudine, and tenofovir disoproxil.[1] As of 2019, it is listed by the World Health Organization (WHO) as the first line treatment for adults, with tenofovir/lamivudine/efavirenz as an alternative.[2] It is taken by mouth.[3]

Dolutegravir/lamivudine/tenofovir
Combination of
DolutegravirIntegrase strand transfer inhibitor
LamivudineNucleoside reverse transcriptase inhibitor
Tenofovir disoproxil fumarateNucleoside reverse transcriptase inhibitor
Clinical data
Other namesTenofovir/lamivudine/dolutegravir (TLD)
ATC code

Side effects may include trouble sleeping, weight gain, and rash.[2][3] While there are concerns that use during pregnancy results in a 0.2% increased risk of neural tube defects in the baby, this does not rule out its use.[2] Use remains recommended after the first trimester.[2] Use is not recommended in those with kidney problems.[3] The combination is a type of antiretroviral therapy.[2]

It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.[4] In some countries it is available as a generic medication.[5] In the developing world it costs about US$75 per year.[6] It is tentatively approved in the United States as of 2019, full approval is pending expiration of the US patents on dolutegravir (Tivicay) and tenofovir disoproxil fumarate (Viread).[7][8]

Medical uses

As of 2019, it is listed by the World Health Organization (WHO) as the first line treatment for adults with HIV/AIDS, with tenofovir/lamivudine/efavirenz as an alternative.[2] It may be used in people with both HIV and tuberculosis, however if the person is on rifampicin a larger dose of dolutegravir is needed.[2]

Side effects

Side effects may include trouble sleeping and weight gain.[2] While there are concerns that use during pregnancy results in a 0.2% increased risk of neural tube defects in the baby, this does not rule out its use.[2] Use remains recommended after the first trimester.[2] It should not be used with dofetilide.[3]

Cost

In the developing world it costs about US$75 per year.[6] It is considered more cost effective than tenofovir/lamivudine/efavirenz as of 2019.[2]

References
  1. "Dolutegravir (DTG) and the fixed dose combination (FDC) of tenofovir/lamivudine/dolutegravir (TLD)" (PDF). World Health Organization (WHO). Retrieved 15 November 2019.
  2. World Health Organization (2019). "Policy brief: update of recommendations on first- and second-line antiretroviral regimens". World Health Organization. hdl:10665/325892. WHO/CDS/HIV/19.15; License: CC BY-NC-SA 3.0 IGO. Cite journal requires |journal= (help)
  3. "WHO-PQ Recommended summary of product characteristics" (PDF). July 2019. Retrieved 16 November 2019.
  4. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  5. "TDF/3TC/DTG" (PDF). Retrieved 16 November 2019.
  6. Vitoria, M; Hill, A; Ford, N; Doherty, M; Clayden, P; Venter, F; Ripin, D; Flexner, C; Domanico, PL (31 July 2018). "The transition to dolutegravir and other new antiretrovirals in low-income and middle-income countries: what are the issues?". AIDS. 32 (12): 1551–61. doi:10.1097/QAD.0000000000001845. PMID 29746295.
  7. "NDA 209618 Tentative Approval" (PDF). U.S. Food and Drug Administration (FDA). 25 March 2019. Retrieved 16 November 2019.
  8. "NDA 210796 Tentative Approval" (PDF). U.S. Food and Drug Administration (FDA). 18 August 2017.
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