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Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV

FEATURED REVIEW First-line therapy for human immunodeficiency virus (HIV) infection is based on a combination of at least three antiretroviral drugs. A formulation of tenofovir, tenofovir alafenamide, was authorised in the EU in late 2015 as part of a fixed-dose combination containing emtricitabine + elvitegravir + cobicistat (Genvoya°). This four-drug fixed-dose combination does not represent a therapeutic advance over other antiretroviral combinations.
Full review (2 pages) available for download by subscribers.

In practice

  • The clinical trials conducted to evaluate tenofovir alafenamide as part of a fixed-dose combination containing emtricitabine + elvitegravir + cobicistat have not shown it to be more effective than tenofovir disoproxil.
     
  • Tenofovir alafenamide seems to have a smaller unfavourable effect on biomarkers of renal function and on bone density than tenofovir disoproxil, but it seems to more often provoke LDL-cholesterol elevation.
     
  • Given that the maximum duration of follow-up was 96 weeks, the clinical and especially cardiovascular consequences of these differences are unknown. Yet patients will be exposed to the treatment for years. In practice, this four-drug fixed-dose combination does not represent a therapeutic advance over other antiretroviral combinations.
     
  •  NOTHING NEW  In three comparative trials in a total of about  2200 HIV-infected patients, tenofovir alafenamide, a new formulation of tenofovir, was no more effective than tenofovir disoproxil in reducing viral load as part of a fixed dose combination containing emtricitabine + elvitegravir + cobicistat. On the basis of laboratory and imaging findings, tenofovir alafenamide provoked fewer kidney and bone disorders, but more lipid disorders. The consequences of these differences are unknown.

©Prescrire 1 June 2017

"Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV" Prescrire Int 2017; 26 (183): 145-146. (Pdf, subscribers only)
Download the full review.
Pdf, subscribers only

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