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Doravirine versus Darunavir

March/April 2017

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Doravirine is an experimental non-nuke that is undergoing phase III clinical trials. It is designed to be effective against most strains of HIV that are resistant to other non-nukes, such as the following:

  • efavirenz (Sustiva, Stocrin and in Atripla)
  • nevirapine
  • rilpivirine (Edurant and in Complera)

Doravirine can be dosed once daily with or without food. In addition to being developed in a 100-mg pill, doravirine is also being developed as a fixed-dose formulation with the following two drugs:

  • tenofovir DF (Viread and in Truvada and many other combinations)
  • 3TC (lamivudine and in Triumeq and many other combinations)

Merck, the developer of doravirine, recently conducted a randomized, placebo-controlled study comparing regimens based on doravirine to regimens based on darunavir (Prezista and Prezcobix). Darunavir is the leading protease inhibitor used in high-income countries today. It has to be taken with a small dose of another drug, ritonavir (Norvir), which helps to boost or maintain levels of darunavir in the blood so that it can be taken only once daily. In its clinical trial Merck found that doravirine was roughly equivalent in potency to darunavir-based regimens.


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Study Details

Upon entering the study the average profile of participants was as follows:

  • no participants had previously used HIV drugs  and no participants were infected with HIV that was resistant to doravirine or darunavir
  • age -- 35 years
  • 84% men, 16% women
  • 10% had symptoms of AIDS in the past
  • 70% had the strain of HIV that is most common in North America and Western Europe -- subtype B
  • viral load -- 25,000 copies/mL
  • 20% of participants had a viral load greater than 100,000 copies/mL
  • CD4+ count -- 422 cells/mm3
  • 14% of participants had a CD4+ count of 200 cells/mm3 or less

The nukes used in this study were as follows:

  • tenofovir DF + FTC
  • abacavir + 3TC

Data were released on study participants after one year. Their distribution was as follows:

  • doravirine-based regimen -- 327 people
  • darunavir-based regimen -- 312 people

The study will continue for two years.


Results -- Changes in Viral Load and CD4+ Cell Counts

Overall, after one year, the proportions of participants who had a viral load less than 50 copies/mL were distributed as follows:

  • doravirine-based regimens -- 84%
  • darunavir-based regimens -- 80%

Statistical analysis found that both regimens are roughly equivalent (the technical term for this is non-inferior).

The following proportions of participants were unable to keep their viral load suppressed:

  • doravirine-based regimens -- 11%
  • darunavir-based regimens -- 13%

Data from the remaining participants was not yet available.

Among participants who entered the study with a viral load greater than 100,000 copies/mL, the proportions with a suppressed viral load at week 48 were as follows:

  • doravirine-based regimens -- 81%
  • darunavir-based regimens -- 76%

Among participants who entered the study with a CD4+ count greater than 200 cells/mm3, the proportions that were virologically suppressed at week 48 were as follows:

  • doravirine-based regimens -- 89%
  • darunavir-based regimens -- 89%

Among participants who entered the study with a CD4+ count between 51 and 200 cells/mm3, the proportions with a suppressed viral load at week 48 were as follows:

  • doravirine-based regimens -- 83%
  • darunavir-based regimens -- 74%

Among participants who entered the study with a CD4+ count of 50 or less cells/mm3, the proportions with a suppressed viral load at week 48 were as follows:

  • doravirine-based regimens -- 83%
  • darunavir-based regimens -- 67%

CD4+ cell counts increased over the course of the study. Below are the average increases in e cell counts for each regimen by week 48:

  • doravirine-based regimens -- 193 cells/mm3
  • darunavir-based regimens -- 186 cells/mm3

This difference in CD4+ cell counts was not statistically significant.


Side Effects

About 30% of all participants experienced side effects; this is relatively common when people begin HIV treatment in or out of clinical trials. In most cases, side effects should fade after a few weeks. However, 2% of participants on doravirine and 3% on darunavir had to quit the study due to side effects.

Common side effects were distributed as follows:

Diarrhea

  • doravirine-based regimens -- 14%
  • darunavir-based regimens -- 22%

Nausea

  • doravirine-based regimens -- 11%
  • darunavir-based regimens -- 12%

Headache

  • doravirine-based regimens -- 11%
  • darunavir-based regimens -- 14%

Rash

  • doravirine-based regimens -- 7%
  • darunavir-based regimens -- 8%
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New NNRTI Doravirine Is Non-Inferior to Darunavir/Ritonavir in Phase 3 Treatment-Naive Study



This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 


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Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

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