What is Tenoviral?
Darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide is usually given to patients who have yet not received any medicine for HIV infection.
Darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide will not keep you from spreading HIV to other people. People who receive darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide may continue to have other problems usually related to AIDS or HIV disease.
Darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide is available only with your doctor's prescription.
Tenoviral indications
In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The following points should be considered when initiating therapy with Tenoviral for the treatment of HIV-1 infection: Tenoviral should not be used in combination with (Tenoviral 300 mg + emtricitabine 200 mg) or (efavirenz + emtricitabine + Tenoviral).
Treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Tenoviral for the treatment of HBV infection: This indication is based primarily on data from treatment of nucleoside-treatment-naive subjects, and a smaller number of subjects who had previously received lamivudine or adefovir. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.
How should I use Tenoviral?
Use Tenoviral powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Tenoviral powder. Talk to your pharmacist if you have questions about this information.
- Take Tenoviral powder by mouth with food as directed.
- Only use the dosing scoop that comes with Tenoviral powder to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Wash and dry your hands immediately before preparing your dose.
- Mix the prescribed dose of Tenoviral powder with 1/4 to 1/2 cup (2 to 4 oz) of a soft food that can be swallowed without chewing (eg, applesauce, baby food, yogurt). Do NOT mix Tenoviral powder with liquid. It may float to the top even after stirring.
- Stir the mixture with a spoon until it is well mixed. Take your dose right away after mixing to avoid a bad taste.
- Wash and dry the dosing scoop after each use. Do NOT store it in the bottle.
- Continue to take Tenoviral powder even if you feel well. Do not miss any doses.
- Taking Tenoviral powder at the same time each day will help you remember to take it.
- Do not suddenly stop taking Tenoviral powder without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. If you have hepatitis B, your condition could become worse if you suddenly stop taking Tenoviral powder.
- If you miss a dose of Tenoviral powder, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tenoviral powder.
Uses of Tenoviral in details
Use: Labeled Indications
Chronic hepatitis B: Treatment of chronic hepatitis B virus (HBV) in patients ≥2 years of age weighing ≥10 kg
HIV-1 infection, treatment: Treatment of HIV-1 infection in patients ≥2 years of age weighing ≥10 kg, in combination with other antiretroviral agents.
Off Label Uses
HIV-1 nonoccupational postexposure prophylaxis
Based on the Centers for Disease Control and Prevention, US Department of Health and Human Services updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV, Tenoviral is effective and recommended (in conjunction with other antiretrovirals) as postexposure prophylaxis of HIV-1 infection following nonoccupational exposure (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that may contain HIV when that exposure represents a substantial risk for HIV transmission.
HIV-1 occupational postexposure prophylaxis
Based on the US Public Health Service updated guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis, Tenoviral (in combination with emtricitabine and raltegravir) is effective and recommended for postexposure prophylaxis of HIV-1 infection in health care personnel following occupational exposure (oPEP) to blood and/or other body fluids that may contain HIV.
Tenoviral description
Tenoviral disoproxil fumarate (a prodrug of Tenoviral), marketed by Gilead Sciences under the trade name Viread®, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. [Wikipedia] In vivo Tenoviral disoproxil fumarate is converted to Tenoviral, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.
Tenoviral dosage
Testing Prior to Initiation of Tenoviral
Prior to or when initiating Tenoviral, test patients for hepatitis B (HBV) virus infection.
Prior to or when initiating Tenoviral, and during treatment with Tenoviral, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
Recommended Dosage
Tenoviral is a four-drug fixed dose combination product containing 800 mg of darunavir (DRV), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of Tenoviral alafenamide (TAF). The recommended dosage of Tenoviral is one tablet taken orally once daily with food in adults. For patients who are unable to swallow the whole tablet, Tenoviral may be split into two pieces using a tablet-cutter, and the entire dose should be consumed immediately after splitting.
Not Recommended in Patients with Severe Renal Impairment
Tenoviral is not recommended in patients with creatinine clearance below 30 mL per minute.
Not Recommended in Patients with Severe Hepatic Impairment
Tenoviral is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
Not Recommended During Pregnancy
Tenoviral is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
Tenoviral should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with Tenoviral.
Tenoviral interactions
See also:
What other drugs will affect Tenoviral?
Co-administration of Tenoviral and didanosine should be undertaken with caution, and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions.
Atazanavir has been shown to increase Tenoviral concentrations. The mechanism of this interaction is unknown. Patients receiving atazanavir and Tenoviral should be monitored for Tenoviral-associated adverse reactions. It should be discontinued in patients who develop Tenoviral-associated adverse reactions. Tenoviral decreases the AUC and Cmax of atazanavir. When co-administered with Tenoviral, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Tenoviral.
Lopinavir/ritonavir has been shown to increase Tenoviral concentrations. The mechanism of this interaction is unknown. Patients receiving lopinavir/ritonavir and Tenoviral should be monitored for Tenoviral-associated adverse reactions. Tenoviral should be discontinued in patients who develop Tenoviral-associated adverse reactions.
Drugs Affecting Renal Function: Since Tenoviral is primarily eliminated by the kidneys, co-administration of Tenoviral with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of Tenoviral and/or increase the concentrations of other renally eliminated drugs. Some examples include, but are not limited to cidofovir, acyclovir, valacyclovir, ganciclovir and valganciclovir. Drugs that decrease renal function may also increase serum concentrations of Tenoviral.
In the treatment of chronic hepatitis B, Tenoviral should not be administered in combination with adefovir dipivoxil.
Tenoviral side effects
See also:
What are the possible side effects of Tenoviral?
The following adverse reactions are discussed in other sections of the labeling:
- Severe acute exacerbations of hepatitis B
- Hepatotoxicity
- Severe skin reactions
- Immune reconstitution syndrome
- New onset or worsening renal impairment
- Lactic acidosis/severe hepatomegaly with steatosis
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adults with No Prior Antiretroviral Treatment History
The safety profile of Tenoviral in HIV-1 infected adults with no prior antiretroviral treatment history is based on Week 48 data from the AMBER trial, a randomized, double-blind, active-controlled trial where a total of 362 subjects received Tenoviral once daily and 363 subjects received a combination of PREZCOBIX® (fixed-dose combination of darunavir and cobicistat) and fixed-dose combination of emtricitabine and Tenoviral disoproxil fumarate (FTC/TDF).
The proportion of subjects who discontinued treatment with Tenoviral or PREZCOBIX+FTC/TDF due to adverse events, regardless of severity, were 2% and 4% respectively.
An overview of the most frequent (occurring in at least 2% of subjects) adverse reactions irrespective of severity reported in AMBER are presented in Table 1. An overview of the most frequent laboratory abnormalities of at least Grade 2 severity reported in AMBER are presented in Table 2. Changes from baseline in lipid parameters for patients receiving Tenoviral and those receiving PREZCOBIX and F/TDF are presented in Table 3.
Most adverse reactions during treatment with Tenoviral were grade 1 or 2 in severity. One grade 3 reaction was reported and no grade 4 adverse reactions were reported during treatment with Tenoviral.
| Tenoviral (N=362) | PREZCOBIX+FTC/TDF (N=363) | |||
|---|---|---|---|---|
| All Grades | At least Grade 2 | All Grades | At least Grade 2 | |
| ||||
| Diarrhea | 9% | 2% | 11% | 2% |
| Rash* | 8% | 4% | 7% | 5% |
| Nausea | 6% | 1% | 10% | 3% |
| Fatigue | 4% | 1% | 4% | 1% |
| Headache | 3% | 1% | 2% | 1% |
| Abdominal discomfort | 2% | - | 4% | <1% |
| Flatulence | 2% | <1% | 1% | - |
Adverse Reactions in Virologically-Suppressed Adults
The safety profile of Tenoviral in virologically-suppressed HIV-1 infected adults is based on Week 48 data from 1,141 subjects in the EMERALD trial, a randomized, open-label, active-controlled trial where 763 subjects with a stable antiretroviral regimen consisting of a boosted protease inhibitor [either darunavir once daily or atazanavir (both boosted with ritonavir or cobicistat), or lopinavir with ritonavir] combined with FTC and TDF switched to Tenoviral, and 378 subjects who continued their treatment regimen of a boosted protease inhibitor with FTC and TDF. Overall, the safety profile of Tenoviral in subjects in this study was similar to that in subjects with no prior antiretroviral treatment history. The proportion of subjects who discontinued treatment with Tenoviral due to adverse events, regardless of severity, was 1%.
Less Frequent Adverse Reactions
The following adverse reactions occurred in less than 2% of adults with no antiretroviral treatment history or virologically suppressed subjects receiving Tenoviral, or are from studies described in the prescribing information of the individual component PREZISTA (darunavir).
Gastrointestinal Disorders: dyspepsia, pancreatitis (acute), vomiting
Skin and Subcutaneous Tissue Disorders: angioedema, pruritus, Stevens-Johnson syndrome
Metabolism and Nutrition Disorders: anorexia, diabetes mellitus, lipodystrophy
Reproductive system and Breast disorders: gynecomastia
Musculoskeletal and Connective Tissue Disorders: myalgia, osteonecrosis
Psychiatric Disorders: abnormal dreams
Immune System Disorders: (drug) hypersensitivity, immune reconstitution inflammatory syndrome
Hepatobiliary Disorders: acute hepatitis
Laboratory Abnormalities
| Laboratory Parameter Grade | Limit | Tenoviral N=362 | PREZCOBIX+FTC/TDF N=363 |
|---|---|---|---|
| Creatinine | |||
| Grade 2 | >1.3 to 1.8 × ULN | 4% | 14% |
| Grade 4 | ≥3.5× ULN | <1% | 0 |
| Triglycerides | |||
| Grade 2 | 301–500 mg/dL | 7% | 4% |
| Grade 3 | 501–1,000 mg/dL | 1% | 1% |
| Grade 4 | > 1,000 mg/dL | <1%% | <1% |
| Total Cholesterol | |||
| Grade 2 | 240–<300 mg/dL | 17% | 4% |
| Grade 3 | >= 300 mg/dL | 2% | 1% |
| Low-Density Lipoprotein Cholesterol | |||
| Grade 2 | 160–189 mg/dL | 9% | 4% |
| Grade 3 | ≥ 190 mg/dL | 5% | 1% |
| Elevated Glucose Levels | |||
| Grade 2 | 126–250 mg/dL | 6% | 6% |
| Grade 3 | 251–500 mg/dL | <1% | 0 |
ALT and/or AST elevations (Grade 2–4 combined) occurred in 2% of adult subjects receiving Tenoviral with no antiretroviral treatment history in AMBER (Week 48 Analysis). Results were consistent in subjects receiving PREZCOBIX+FTC/TDF.
| Tenoviral N=356 | PREZCOBIX+FTC/TDF N=355 | |||
|---|---|---|---|---|
| Baseline | Week 48 | Baseline | Week 48 | |
| Mean† | mg/dL | Change | mg/dL | Change |
| N=304‡ | N=290 | |||
| ||||
| Total cholesterol | 168 | +30 | 164 | +11 |
| HDL cholesterol | 45 | +6 | 44 | +2 |
| LDL cholesterol | 199 | +19 | 98 | +5 |
| Triglycerides | 117 | +34 | 112 | +21 |
| Total cholesterol to HDL ratio | 4.1 | 0.2 | 4.0 | 0.1 |
The percentage of subjects starting any lipid lowering drug during treatment in the Tenoviral and PREZCOBIX + FTC/TDF arm were 1.7% (n=6) and 0.6% (n=2), respectively.
Renal Laboratory Tests
In the AMBER trial, which had 670 adults with no prior antiretroviral treatment history with a median baseline eGFR of 119 mL/min (Tenoviral) and 118 mL/min (PREZCOBIX + FTC/TDF), mean (SD) serum creatinine increased by 0.05 (0.10) mg/dL in the Tenoviral group and by 0.09 (0.11) mg/dL in the PREZCOBIX + FTC/TDF group from baseline to Week 48. Median serum creatinine was 0.90 mg/dL (Tenoviral) and 0.89 mg/dL (PREZCOBIX + FTC/TDF) at baseline and 0.95 mg/dL (Tenoviral) and 0.97 mg/dL (PREZCOBIX +FTC/TDF) at Week 48. Increases in serum creatinine occurred by Week 2 of treatment and remained stable. Median urine protein-to-creatinine ratio (UPCR) was 47 mg per gram (Tenoviral) and 51 mg/g (PREZCOBIX + FTC/TDF) at baseline and 30 mg per gram (Tenoviral) and 34 mg/g (PREZCOBIX + FTC/TDF) at Week 48.
In the EMERALD trial which had 1,141 virologically-suppressed adults treated with an HIV protease inhibitor and TDF containing regimen with a median baseline eGFR of 104 mL/min (Tenoviral) and 103 mL/min (bPI+FTC/TDF) who were randomized to continue their treatment regimen or switch to Tenoviral, at Week 48, mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to Tenoviral. Mean (SD) serum creatinine was 0.98 (0.18) mg/dL (Tenoviral) and 0.98 (0.19) mg/dL (bPI+FTC/TDF) at baseline and 0.99 (0.18) mg/dL (Tenoviral) and 0.99 (0.21) mg/dL (bPI+FTC/TDF) at Week 48. Median serum creatinine was 0.97 mg/dL (Tenoviral) and 0.98 mg/dL (bPI+FTC/TDF) at baseline and 1.0 mg/dL (Tenoviral) and 0.97 mg/dL (bPI+FTC/TDF) at Week 48. Median UPCR was 62 mg per gram (Tenoviral) and 63 mg/g (bPI+FTC/TDF) at baseline and 37 mg per gram (Tenoviral) and 53 mg/g (bPI+FTC/TDF) at Week 48.
Bone Mineral Density
AMBER
The effects of Tenoviral compared to PREZCOBIX + FTC/TDF on bone mineral density (BMD) change from baseline to Week 48 were assessed by dual-energy X-ray absorptiometry (DXA). The mean percentage change in BMD from baseline to Week 48 was −0.7% with Tenoviral compared to −2.4% with DRV/COBI + FTC/TDF at the lumbar spine and 0.2% compared to −2.7% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 16% of Tenoviral subjects and 22% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by 2% of Tenoviral subjects and 15% of PREZCOBIX + FTC/TDF subjects. The long-term clinical significance of these BMD changes is not known.
EMERALD
In EMERALD, boosted Protease Inhibitor (bPI) and TDF-treated subjects were randomized to continue their TDF-based regimen or switch to Tenoviral; changes in BMD from baseline to Week 48 were assessed by DXA. The mean percentage change in BMD from baseline to Week 48 was 1.5% with Tenoviral compared to −0.6% with PREZCOBIX + FTC/TDF at the lumbar spine and 1.4% compared to -0.3% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 2% of Tenoviral subjects and 9% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by no Tenoviral subjects and 2% of PREZCOBIX + FTC/TDF subjects. The long-term clinical significance of these BMD changes is not known.
Postmarketing Experience
The following adverse reactions have been identified during postmarketing experience in patients receiving a darunavir-containing regimen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Metabolism and Nutrition Disorders
Redistribution of body fat
Musculoskeletal and Connective Tissue Disorders
Rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors)
Skin and Subcutaneous Tissue Disorders
Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms.
Tenoviral contraindications
See also:
What is the most important information I should know about Tenoviral?
Tenoviral is contraindicated with the following co-administered drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect.
- Alpha 1-adrenoreceptor antagonist: alfuzosin
- Antianginal: ranolazine
- Antiarrhythmic: dronedarone
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Anti-gout: colchicine, in patients with renal/and or hepatic impairment
- Antimycobacterial: rifampin
- Antipsychotics: lurasidone, pimozide
- Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine
- GI motility agent: cisapride
- Herbal product: St. John's wort (Hypericum perforatum)
- Hepatitis C direct acting antiviral: elbasvir/grazoprevir
- HMG-CoA reductase inhibitors: lovastatin, simvastatin
- PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension
- Sedatives/hypnotics: orally administered midazolam, triazolam
Active ingredient matches for Tenoviral:
Tenofovir in Bosnia & Herzegowina, Turkey.
List of Tenoviral substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Tenofovirdizoproksil Pliva (Croatia (Hrvatska)) | |
| Tenozet (Japan) | |
| Tenribel (Turkey) | |
| TENVIR (India) | |
| 300 mg x 30's (Cipla Limited) | $ 18.07 |
| Tenvir 300mg TAB / 30 (Cipla Limited) | $ 18.07 |
| Tenvir 300 mg Tablet (Cipla Limited) | $ 1.20 |
| TENVIR 300 MG TABLET 1 strip / 30 tablets each (Cipla Limited) | $ 16.62 |
| TENVIR tab 300 mg x 30's (Cipla Limited) | $ 18.07 |
| Tenvir 300mg TAB / 30 (Cipla Limited) | $ 18.07 |
| Tenvir 300mg Tablet (Cipla Limited) | $ 0.58 |
| Tenvira (Bangladesh) | |
| Tenvira FC tab 300 mg 10's (Aristopharma) | |
| Tenvira FC tab 300 mg 20's (Aristopharma) | |
| Tenvira FC tab 300 mg 30's (Aristopharma) | |
| Tenvor (Lebanon) | |
| TERAVIR | |
| TERAVIR 300MG TABLET 1 strip / 30 tablets each (Natco Pharma Ltd) | $ 20.65 |
| Ternavir (Turkey) | |
| Teva-Tenofovir (Canada) | |
| Tevir (Vietnam) | |
| Tevir FC tab 300 mg 30's (Sun Pharma) | |
| Valten | |
| Valten 300mg Tablet (Wockhardt Ltd) | $ 0.57 |
| VALTEN 300 MG TABLET | |
| VALTEN 300 MG TABLET 1 strip / 30 tablets each (Wockhardt Ltd) | $ 17.21 |
| Veforix (Turkey) | |
| Vemlidy 25mg (Austria, Luxembourg) | |
| Vidara (Argentina) | |
| Virakam (Argentina) | |
| Viread 123mg (Austria, Germany) | |
| Viread 163mg (Austria, Germany) | |
| Viread 204mg (Austria, Germany) | |
| Viread 245mg (Austria, Germany, Hungary, Luxembourg, Switzerland) | |
| Viread 33mg/g (Austria, Germany) | |
| Viread Paranova (Iceland) | |
| Viread Powder | |
| Virkil (Vietnam) | |
| Virkil 300 mg x 1 Blister x 10 Tablet | |
| Virkil 300 mg x 3 Blister x 10 Tablet | |
| Virofob (Iceland, Romania) | |
| Virofob 245 mg (Hungary) | |
| Virsoem (Turkey) | |
| Virtenix (Turkey) | |
| Voxus (Turkey) | |
| Xynovir (Bangladesh) | |
| Zentovir (Turkey) | |
| Zifam Tenovir (Myanmar) | |
| Zifam Tenovir FC tab 300 mg 6 x 10's (Zifam India) | |
See 179 substitutes for Tenoviral | |
Reviews
The results of a survey conducted on ndrugs.com for Tenoviral are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tenoviral. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yet1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?The below mentioned numbers have been reported by ndrugs.com website users about whether the Tenoviral drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
| Users | % | ||
|---|---|---|---|
| Not expensive | 1 | 100.0% | |
1 consumer reported time for results
To what extent do I have to use Tenoviral before I begin to see changes in my health conditions?As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Tenoviral. To get the time effectiveness of using Tenoviral drug by other patients, please click here.
| Users | % | ||
|---|---|---|---|
| 1 month | 1 | 100.0% | |
3 consumers reported age
| Users | % | ||
|---|---|---|---|
| 30-45 | 2 | 66.7% | |
| > 60 | 1 | 33.3% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
