Genvoya (Page 10 of 11)
14.4 Clinical Trial Results in HIV-1 Infected Subjects with Renal Impairment
Study 112: Virologically-suppressed adults with renal impairment
In Study 112, the efficacy and safety of GENVOYA once daily were evaluated in an open-label clinical trial of 248 HIV-1 infected subjects with renal impairment (estimated creatinine clearance between 30 and 69 mL per minute by Cockcroft-Gault method). Of the 248 enrolled, 6 were treatment-naïve and 242 were virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months before switching to GENVOYA [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
The mean age was 58 years (range 24–82), with 63 subjects (26%) who were 65 years of age or older. Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian. Thirteen percent of subjects identified as Hispanic/Latino. The mean baseline CD4+ cell count was 664 cells per mm3 (range 126–1813). At Week 144, 81% (197/242 virologically suppressed subjects) maintained HIV-1 RNA less than 50 copies per mL after switching to GENVOYA. All six treatment-naïve subjects were virologically suppressed at Week 144. Five subjects among the entire study population had virologic failure at Week 144.
Study 1825: Virologically-suppressed adults with end stage renal disease (ESRD) receiving chronic hemodialysis
In Study 1825, the efficacy and safety of GENVOYA once daily were evaluated in an open-label clinical trial of 55 virologically-suppressed (HIV-1 RNA less than 50 copies per mL for at least 6 months before switching to GENVOYA) HIV-1 infected subjects with ESRD (estimated creatinine clearance of less than 15 mL per minute by Cockcroft-Gault method) receiving chronic hemodialysis for at least 6 months [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Subjects had a mean age of 48 years (range 23–64), 76% were male, 82% were Black, 18% were White, and 15% identified as Hispanic/Latino. The mean baseline CD4+ cell count was 545 cell per mm3 (range 205–1473). At Week 48, 82% (45/55) maintained HIV-1 RNA less than 50 copies per mL after switching to GENVOYA. Two subjects had HIV-1 RNA ≥ 50 copies per mL by Week 48. Seven subjects discontinued the study drug due to AE or other reasons while suppressed. One subject did not have an HIV-1 RNA measurement at Week 48.
14.5 Clinical Trial Results in HIV-1 Infected Pediatric Subjects Between the Ages of 6 to Less than 18 Years
In Study 106, an open-label, single arm trial the efficacy, safety, and pharmacokinetics of GENVOYA in HIV-1 infected pediatric subjects were evaluated in treatment-naïve adolescents between the ages of 12 to less than 18 years weighing at least 35 kg (N=50) and in virologically-suppressed children between the ages of 6 to less than 12 years weighing at least 25 kg (N=52).
Cohort 1: Treatment-naïve adolescents (12 to less than 18 years; at least 35 kg)
Subjects in cohort 1 treated with GENVOYA once daily had a mean age of 15 years (range 12-17); 44% were male, 12% were Asian, and 88% were Black. At baseline, mean plasma HIV-1 RNA was 4.6 log10 copies per mL (22% had baseline plasma HIV-1 RNA greater than 100,000 copies per mL), mean (SD) CD4+ cell count was 471 (212.2) cells per mm3 , and mean (SD) CD4+ percentage was 23.6% (8.8%).
In subjects in cohort 1 treated with GENVOYA, 92% (46/50) achieved HIV-1 RNA less than 50 copies per mL at Week 48. The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells per mm3. Three of 50 subjects had virologic failure at Week 48; no emergent resistance to GENVOYA was detected through Week 48.
Cohort 2: Virologically-suppressed children (6 to less than 12 years; at least 25 kg)
Subjects in cohort 2 treated with GENVOYA once daily had a mean age of 10 years (range: 7–11), a mean baseline weight of 31.7 kg, 42% were male, 25% were Asian, and 71% were Black. At baseline, the mean (SD) CD4+ cell count was 961 (275.5) cells per mm3 and the mean (SD) CD4 percentage was 38.2% (6.4%). After switching to GENVOYA, 98% (51/52) of subjects in cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48. No subject qualified for resistance analysis through Week 48. The mean change from baseline in CD4+ cell count was -66 (203.6) cells per mm3 and the mean (SD) change in CD4 percentage was -0.6% (4.4%) at Week 48. All subjects maintained CD4+ cell counts above 400 cells/mm3 [see Adverse Reactions (6.1) and Pediatric Use (8.4)].
16 HOW SUPPLIED/STORAGE AND HANDLING
GENVOYA tablets are available in bottles containing 30 tablets with a silica gel desiccant, polyester coil, and child-resistant closure as follows:
- GENVOYA tablets each contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF). These tablets are green, capsule-shaped, film-coated, debossed with “GSI” on one side of the tablet and the number “510” on the other side (NDC 61958-1901-1).
Store below 30 °C (86 °F).
- Keep container tightly closed.
- Dispense only in original container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Drug Interactions
GENVOYA may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John’s wort [see Contraindications (4) and Drug Interactions (7)].
Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Co-Infection
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine and/or TDF, and may likewise occur with discontinuation of GENVOYA [see Warnings and Precautions (5.1)]. Advise the patient to not discontinue GENVOYA without first informing their healthcare provider.
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.3)].
Renal Impairment
Advise patients to avoid taking GENVOYA with concurrent or recent use of nephrotoxic agents. Postmarketing cases of renal impairment, including acute renal failure, have been reported [see Warnings and Precautions (5.4)].
Lactic Acidosis and Severe Hepatomegaly
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to GENVOYA. Advise patients that they should stop GENVOYA if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.5)].
Missed Dosage
Inform patients that it is important to take GENVOYA on a regular dosing schedule with food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.2)].
Pregnancy
Advise patients that GENVOYA is not recommended during pregnancy and to alert their healthcare provider if they become pregnant while taking GENVOYA [see Dosage and Administration (2.5) and Use in Specific Populations (8.1)]. Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to GENVOYA [see Use in Specific Populations (8.1)].
Lactation
Instruct patients with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].
Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404
| This Patient Information has been approved by the U.S. Food and Drug Administration | Revised: 01/2022 |
| Patient Information | |
| GENVOYA® (jen-VOY-uh)(elvitegravir, cobicistat, emtricitabine,and tenofovir alafenamide)tablets | |
| Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with GENVOYA. For more information, see the section “What should I tell my healthcare provider before taking GENVOYA?“ | |
| What is the most important information I should know about GENVOYA? GENVOYA can cause serious side effects, including:
For more information about side effects, see “What are the possible side effects of GENVOYA?“ | |
| What is GENVOYA? GENVOYA is a prescription medicine that is used without other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in adults and children who weigh at least 55 pounds (25 kg):
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). GENVOYA contains the prescription medicines elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. It is not known if GENVOYA is safe and effective in children who weigh less than 55 pounds (25 kg). | |
| Do not take GENVOYA if you also take a medicine that contains: | |
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| What should I tell my healthcare provider before taking GENVOYA? Before taking GENVOYA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with GENVOYA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
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| How should I take GENVOYA?
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| What are the possible side effects of GENVOYA? GENVOYA may cause serious side effects, including:
The most common side effect of GENVOYA is nausea. These are not all the possible side effects of GENVOYA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
| How should I store GENVOYA?
Keep GENVOYA and all medicines out of reach of children. | |
| General information about the safe and effective use of GENVOYA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GENVOYA for a condition for which it was not prescribed. Do not give GENVOYA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about GENVOYA that is written for health professionals. | |
| What are the ingredients in GENVOYA? Active ingredients: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and sodium lauryl sulfate. The tablets are film-coated with a coating material containing FD&C Blue No. 2/indigo carmine aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 GENVOYA is a trademark of Gilead Sciences, Inc., or its related companies. © 2022 Gilead Sciences, Inc. All rights reserved. 207561-GS–017 For more information, call 1-800-445-3235 or go to www.GENVOYA.com. | |
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