Elvitegravir Cobicistat Emtricitabine Tenofovir Alafenamide Brand Name– Genvoya
What is Elvitegravir Cobicistat Emtricitabine Tenofovir Alafenamide
Elvitegravir Cobicistat Emtricitabine Tenofovir Alafenamide (Genvoya) is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral-naive adults and pediatric patients who weigh at least 25 kg.
The drug is also approved as a replacement therapy in treatment-experienced patients who have been virologically-suppressed (i.e., HIV RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months, have no history of treatment failure, and who are without known substitutions associated with resistance to any of the individual components.
Similar to Stribild, Genvoya is a fixed-dose combination tablet containing 4 medications (elvitegravir, an HIV integrase strand transfer inhibitor; cobicistat, a pharmacokinetic enhancer; emtricitabine, a nucleoside reverse transcriptase inhibitor or NRTI; tenofovir, an acyclic nucleotide reverse transcriptase inhibitor) in a single tablet that is administered once daily.
However, Genvoya contains a different tenofovir prodrug, tenofovir alafenamide, which provides lower concentrations in the bloodstream, but higher concentrations within the cells where HIV-1 replicates; tenofovir alafenamide was developed to help reduce adverse events.
Stribild and Genvoya are NOT interchangeable.
Elvitegravir Cobicistat Emtricitabine Tenofovir Alafenamide constitutes a complete HIV treatment regimen; thus, administration with other antiretroviral medications is not recommended.
Approval was based on the results of randomized clinical trials involving treatment-naive and virologically suppressed adults and open-label trials in treatment-naive and virologically suppressed pediatric patients. Data from the randomized trials found the efficacy of Genvoya (range, 92% to 93%) to be comparable to that observed with the antiretroviral control regimens (range, 89% to 90%).
The antiretroviral control regimens included one of the following: elvitegravir; cobicistat; emtricitabine; tenofovir disoproxil fumarate (Stribild), efavirenz; emtricitabine; tenofovir DF (Atripla), or emtricitabine; tenofovir DF plus atazanavir boosted with either ritonavir or cobicistat.
In the open-label pediatric trials, efficacy of Genvoya ranged from 92% to 100%. In each study, efficacy was defined as an HIV RNA concentration less than 50 copies/mL.
Genvoya contains two medications used for the treatment of chronic hepatitis B virus (HBV) infection (tenofovir and emtricitabine); however, it is not approved for this indication, nor is it indicated for the treatment of the patient coinfected with HBV and HIV.
All patients should be tested for HBV infection prior to initiating treatment with Genvoya.
The package labeling has a Black Box Warning that acute exacerbations of hepatitis B have been reported in patients after discontinuation of tenofovir DF and emtricitabine.
If treatment for HIV infection is discontinued in a patient coinfected with HBV, the patient should be closely monitored for several months for signs and symptoms of worsening hepatic function.
Indications
- human immunodeficiency virus (HIV)
- human immunodeficiency virus (HIV) infection
Side Effects
- angioedema
- diarrhea
- elevated hepatic enzymes
- fatigue
- fluid retention
- headache
- hematuria
- hepatic decompensation
- hepatic failure
- hepatitis B exacerbation
- hepatomegaly
- hyperamylasemia
- hypercholesterolemia
- hyperkalemia
- hyperlipidemia
- hypertriglyceridemia
- lactic acidosis
- nausea
- osteomyelitis
- osteopenia
- osteoporosis
- rash
- renal failure (unspecified)
- steatosis
- suicidal ideation
- urticaria
- uveitis
- weight gain
Monitoring Parameters
- blood glucose
- CBC with differential
- CD4+ T cell count
- hepatitis B serology
- LFTs
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum bilirubin (total and direct)
- serum cholesterol
- serum creatinine/BUN
- serum lipid profile
- serum phosphate
- urinalysis
Contraindications
- alcoholism
- autoimmune disease
- Black patients
- bone fractures
- breast-feeding
- depression
- females
- Graves’ disease
- Guillain-Barre syndrome
- hepatic disease
- hepatitis B and HIV coinfection
- hepatitis B exacerbation
- hepatitis C and HIV coinfection
- hepatotoxicity or lactic acidosis
- Hispanic patients
- human immunodeficiency virus (HIV) infection resistance
- hypophosphatemia
- immune reconstitution syndrome
- obesity
- osteomalacia
- osteoporosis
- pregnancy
- renal disease
- renal failure
- renal impairment
- suicidal ideation
Interactions
- Abacavir; Dolutegravir; Lamivudine
- Abacavir; Lamivudine, 3TC
- Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
- Abemaciclib
- Acalabrutinib
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- Vincristine Liposomal
- Vinorelbine
- Vorapaxar
- Voriconazole
- Voxelotor
- Warfarin
- Yohimbine
- Zafirlukast
- Zaleplon
- Zanubrutinib
- Zileuton
- Ziprasidone
- Zoledronic Acid
- Zolmitriptan
- Zolpidem
- Zonisamide
