TreatmentUpdate
228

July/August 2018 

Switching from Triumeq to Biktarvy

Triumeq is the brand name of a pill containing the following three anti-HIV medicines:

  • dolutegravir
  • abacavir
  • 3TC

Triumeq is a complete HIV treatment—taken once daily, with or without food, day or night—and is widely used. Clinical trials have found it to be highly effective and generally well tolerated, though some users have reported difficulty falling asleep and/or staying asleep.

Biktarvy is the brand name of a pill with the following three anti-HIV medicines:

  • bictegravir
  • TAF (tenofovir alafenamide)
  • FTC (emtricitabine)

Dolutegravir and bictegravir belong to a class of drugs called integrase inhibitors.

In a double-blind study conducted in Canada and other countries, researchers recruited participants who were taking Triumeq and who had undetectable viral loads (less than 50 copies/mL) and randomly assigned them to receive one of the following:

  • Biktarvy – 282 people
  • continue taking Triumeq – 281 people

At 48 weeks, similar proportions of participants maintained an undetectable viral load. Although rates of side effects were greater among people who continued taking Triumeq, more people quit Biktarvy than Triumeq because of bothersome side effects.

Study details

The average profile of participants upon entering the study was as follows:

  • 87% men, 13% women
  • age – 46 years
  • major ethno-racial groups: white – 73%; black – 21%; Asian – 3%; Indigenous – 2%
  • CD4+ count – 700 cells/mm3
  • 87% did not have symptoms of HIV disease
  • hepatitis B virus (HBV) co-infection – no people
  • hepatitis C virus (HCV) co-infection – 1 person
  • eGFR (estimated glomerular filtration rate; a general measure of kidney health) – 101 mL/minute

Results

At the 48th week of the study, the proportions of participants with a viral load less than 50 copies/mL were similar and distributed as follows:

  • Biktarvy – 94%
  • continued Triumeq – 95%

Also, at week 48, the proportions of participants with a viral load less than 20 copies/mL were distributed as follows:

  • Biktarvy – 90%
  • continued Triumeq – 91%

These differences were not statistically significant and suggest that both regimens have similar effectiveness. The technical term for this is that Biktarvy is “non-inferior” to Triumeq.

Safety

The researchers stated that both regimens were “well tolerated” and most side effects that occurred were “mild or moderate in severity.”

Premature withdrawal from the study due to drug-related side effects was uncommon and distributed as follows:

  • Biktarvy – 2% (six people)
  • continued Triumeq – 1% (two people)

These side effects were distributed as follows:

Biktarvy

  • headache – two people
  • abnormal dreams – one person
  • stroke – one person
  • vomiting – one person
  • thoughts of suicide – one person

Investigation suggested that these issues were likely related to Biktarvy—all except for the thoughts of suicide, as researchers stated that the person had an “extensive psychiatric history” prior to entering the study.

Triumeq

  • headache – one person
  • itchy skin – one person

Investigation suggested that both of these problems were likely related to the use of Triumeq.

The distribution of side effects that were not serious was as follows:

Headache

  • Biktarvy – 2%
  • Triumeq – 3%

Diarrhea

  • Biktarvy – 1%
  • Triumeq – 1%

Abnormal dreams

  • Biktarvy – less than 1%
  • Triumeq – 2%

Nausea

  • Biktarvy – 0%
  • Triumeq – 2%

Difficulty falling asleep and/or staying asleep

  • Biktarvy – 0%
  • Triumeq – 1%

Other issues

Between 2% and 3% of participants on each study regimen developed fractures. However, investigation revealed that these were not due to the study medicines.

Overall, when it came to measures of kidney health, there were no clinically significant differences between regimens.

Deaths

Two people taking Biktarvy died. One person died because their heart stopped beating—a consequence of serious cardiovascular disease. Another person died because of toxicity arising from excess intake of alcohol combined with opioids.

No one taking Triumeq died.

Abnormal lab test results

About 3% of participants on each study regimen developed abnormal lab test results. No one suffered serious injury associated with these lab test results.

Overall, there were no clinically significant changes in routine laboratory measures of kidney and heart health (cholesterol and triglycerides).

Bear in mind

The present study suggests that, overall, both Biktarvy and Triumeq are generally well tolerated. Most side effects were mild and temporary.

—Sean R. Hosein

REFERENCE:

Molina JM, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48-week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018; in press.

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