Genvoya is a fixed-dose tablet combining 150mg of elvitegravir, 150mg of cobicistat, 200mg of emtricitabine and 10mg of tenofovir alafenamide (TAF). It is manufactured by Gilead Sciences.
Elvitegravir is an integrase inhibitor. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI). These drugs reduce the amount of HIV in the body. Cobicistat is an agent used to boost levels of elvitegravir. It has no anti-HIV activity of its own. Genvoya provides a full anti-HIV drug combination in one pill.
Genvoya received marketing approval in the United States and European Union in November 2016. For details of the studies that led to the approval of Genvoya see elvitegravir.
The standard dose of Genvoya is one pale green tablet once day, taken with food. It is licensed for use in adults over 18 years of age.
Taking calcium, iron, magnesium or aluminium can stop you from absorbing Genvoya properly – all multivitamin and mineral supplements and antacids must be taken at least 4 hours before or after Genvoya.
Common side effects of Genvoya (reported by at least 1% of participants in clinical trials):
- Nausea, vomiting, diarrhoea, flatulence
- headache, dizziness, abnormal dreams, fatigue
- skin rash.
An analysis of eight clinical trials of new drugs introduced after 2003 found that weight gain was significantly greater in people taking an integrase inhibitor and that dolutegravir or bictegravir were associated with a higher risk of substantial weight gain (>10% of body mass) than elvitegravir. (Sax 2019)
Genvoya should not be used with the following drugs:
- alpha 1-adrenoreceptor antagonists: alfuzosin
- antiarrhythmics: amiodarone, quinidine
- ergot derivatives: dihydroergotamine, ergometrine, ergotamine
- gastrointestinal motility agents: cisapride
- statins: lovastatin, simvastatin
- lipid-modifying agent: lomitapide
- neuroleptics/antipsychotics: pimozide, lurasidone
- PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension
- sedatives/hypnotics: orally administered midazolam, triazolam
- anticonvulsants: carbamazepine, phenobarbital, phenytoin
- antimycobacterials: rifampicin
- herbal products: St John's wort.
As with other agents boosted with cobicistat, the use of elvitegravir during pregnancy is not recommended due to lower drug levels during the third trimester.
Genvoya is approved for use in children aged 12 years and over weighing 35kg or more. It may also be used in children aged six years and over weighing 25kg or more if they cannot tolerate other HIV treatments because of side effects.
Sax P et al. Weight gain following initiation of antiretroviral therapy: risk factors in randomized comparative clinical trials. Clinical Infectious Diseases, 71: 1379-89, 2019.