Tenvira Uses

How do you administer this medicine?
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What is Tenvira?

Darunavir, cobicistat, emtricitabine, and Tenvira 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 Tenvira alafenamide is usually given to patients who have yet not received any medicine for HIV infection.

Darunavir, cobicistat, emtricitabine, and Tenvira 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 Tenvira alafenamide will not keep you from spreading HIV to other people. People who receive darunavir, cobicistat, emtricitabine, and Tenvira alafenamide may continue to have other problems usually related to AIDS or HIV disease.

Darunavir, cobicistat, emtricitabine, and Tenvira alafenamide is available only with your doctor's prescription.

Tenvira indications

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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 Tenvira for the treatment of HIV-1 infection: Tenvira should not be used in combination with (Tenvira 300 mg + emtricitabine 200 mg) or (efavirenz + emtricitabine + Tenvira).

Treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Tenvira 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 Tenvira?

Use Tenvira powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tenvira powder.

Uses of Tenvira in details

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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, Tenvira 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, Tenvira (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.

Tenvira description

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Tenvira (a prodrug of Tenvira), 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 Tenvira is converted to Tenvira, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Tenvira dosage

Testing Prior to Initiation of Tenvira

Prior to or when initiating Tenvira, test patients for hepatitis B (HBV) virus infection.

Prior to or when initiating Tenvira, and during treatment with Tenvira, 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

Tenvira 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 Tenvira alafenamide (TAF). The recommended dosage of Tenvira is one tablet taken orally once daily with food in adults. For patients who are unable to swallow the whole tablet, Tenvira 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

Tenvira is not recommended in patients with creatinine clearance below 30 mL per minute.

Not Recommended in Patients with Severe Hepatic Impairment

Tenvira is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).

Not Recommended During Pregnancy

Tenvira is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.

Tenvira should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with Tenvira.

Tenvira interactions

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What other drugs will affect Tenvira?

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Co-administration of Tenvira 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 Tenvira concentrations. The mechanism of this interaction is unknown. Patients receiving atazanavir and Tenvira should be monitored for Tenvira-associated adverse reactions. It should be discontinued in patients who develop Tenvira-associated adverse reactions. Tenvira decreases the AUC and Cmax of atazanavir. When co-administered with Tenvira, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Tenvira.

Lopinavir/ritonavir has been shown to increase Tenvira concentrations. The mechanism of this interaction is unknown. Patients receiving lopinavir/ritonavir and Tenvira should be monitored for Tenvira-associated adverse reactions. Tenvira should be discontinued in patients who develop Tenvira-associated adverse reactions.

Drugs Affecting Renal Function: Since Tenvira is primarily eliminated by the kidneys, co-administration of Tenvira with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of Tenvira 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 Tenvira.

In the treatment of chronic hepatitis B, Tenvira should not be administered in combination with adefovir dipivoxil.

Tenvira side effects

See also:
What are the possible side effects of Tenvira?

The following adverse reactions are discussed in other sections of the labeling:

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 Tenvira 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 Tenvira once daily and 363 subjects received a combination of PREZCOBIX® (fixed-dose combination of darunavir and cobicistat) and fixed-dose combination of emtricitabine and Tenvira (FTC/TDF).

The proportion of subjects who discontinued treatment with Tenvira 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 Tenvira and those receiving PREZCOBIX and F/TDF are presented in Table 3.

Most adverse reactions during treatment with Tenvira were grade 1 or 2 in severity. One grade 3 reaction was reported and no grade 4 adverse reactions were reported during treatment with Tenvira.

Table 1: Adverse Reactions Reported in ≥2% of HIV-1 Infected Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
Tenvira

(N=362)

PREZCOBIX+FTC/TDF

(N=363)

All Grades At least Grade 2 All Grades At least Grade 2
*
Includes pooled reported terms: dermatitis, dermatitis allergic, erythema, photosensitivity reaction, rash, rash generalized, rash macular, rash maculo-papular, rash morbilliform, rash pruritic, toxic skin eruption, urticaria
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 Tenvira 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 Tenvira, and 378 subjects who continued their treatment regimen of a boosted protease inhibitor with FTC and TDF. Overall, the safety profile of Tenvira 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 Tenvira 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 Tenvira, 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

Table 2: Laboratory Abnormalities (Grade 2–4) Reported in ≥2% of Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
Laboratory Parameter

Grade

Limit Tenvira

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 Tenvira with no antiretroviral treatment history in AMBER (Week 48 Analysis). Results were consistent in subjects receiving PREZCOBIX+FTC/TDF.

Table 3: Lipid Values, Mean Change from Baseline, Reported in Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)*
Tenvira

N=356

PREZCOBIX+FTC/TDF

N=355

Baseline Week 48 Baseline Week 48
Mean† mg/dL Change mg/dL Change
N=304‡ N=290
*
Subjects on lipid-lowering agents at screening/baseline were excluded from the analysis (6 out of 362 subjects on Tenvira, 8 out of 363 subjects on PREZCOBIX+FTC/TDF). Subjects initiating a lipid-lowering agent post-baseline had their last fasted on-treatment value (prior to starting the agent) carried forward (6 on Tenvira, 2 on PREZCOBIX+FTC/TDF).
The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 48 values, or the last value carried forward prior to initiating lipid-lowering agent post-baseline.
One subject did not have a Week 48 result for LDL cholesterol (n=303).
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 Tenvira 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 (Tenvira) and 118 mL/min (PREZCOBIX + FTC/TDF), mean (SD) serum creatinine increased by 0.05 (0.10) mg/dL in the Tenvira 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 (Tenvira) and 0.89 mg/dL (PREZCOBIX + FTC/TDF) at baseline and 0.95 mg/dL (Tenvira) 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 (Tenvira) and 51 mg/g (PREZCOBIX + FTC/TDF) at baseline and 30 mg per gram (Tenvira) 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 (Tenvira) and 103 mL/min (bPI+FTC/TDF) who were randomized to continue their treatment regimen or switch to Tenvira, at Week 48, mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to Tenvira. Mean (SD) serum creatinine was 0.98 (0.18) mg/dL (Tenvira) and 0.98 (0.19) mg/dL (bPI+FTC/TDF) at baseline and 0.99 (0.18) mg/dL (Tenvira) and 0.99 (0.21) mg/dL (bPI+FTC/TDF) at Week 48. Median serum creatinine was 0.97 mg/dL (Tenvira) and 0.98 mg/dL (bPI+FTC/TDF) at baseline and 1.0 mg/dL (Tenvira) and 0.97 mg/dL (bPI+FTC/TDF) at Week 48. Median UPCR was 62 mg per gram (Tenvira) and 63 mg/g (bPI+FTC/TDF) at baseline and 37 mg per gram (Tenvira) and 53 mg/g (bPI+FTC/TDF) at Week 48.

Bone Mineral Density

AMBER

The effects of Tenvira 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 Tenvira 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 Tenvira subjects and 22% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by 2% of Tenvira 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 Tenvira; 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 Tenvira 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 Tenvira subjects and 9% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by no Tenvira 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.

Tenvira contraindications

See also:
What is the most important information I should know about Tenvira?

Tenvira is contraindicated with the following co-administered drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect.



Active ingredient matches for Tenvira:

Tenofovir in Bangladesh.

Tenofovir disoproxil fumarate in Myanmar.


Unit description / dosage (Manufacturer)Price, USD
Tenvira FC tab 300 mg 10's (Aristopharma)
Tenvira FC tab 300 mg 20's (Aristopharma)
Tenvira FC tab 300 mg 30's (Aristopharma)

List of Tenvira substitutes (brand and generic names):

Tentide 300mg TAB / 30 (Super Speciality (Ranbaxy Laboratories Ltd))$ 36.02
300 mg x 30's (Super Speciality (Ranbaxy Laboratories Ltd))$ 36.02
Tentide 300 mg Tablet (Super Speciality (Ranbaxy Laboratories Ltd))$ 1.20
TENTIDE 300 MG TABLET 1 strip / 30 tablets each (Super Speciality (Ranbaxy Laboratories Ltd))$ 18.07
TENTIDE tab 300 mg x 30's (Super Speciality (Ranbaxy Laboratories Ltd))$ 36.02
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
TERAVIR 300MG TABLET 1 strip / 30 tablets each (Natco Pharma Ltd)$ 20.65
Tevir FC tab 300 mg 30's (Sun Pharma)
Valten 300mg Tablet (Wockhardt Ltd)$ 0.57
VALTEN 300 MG TABLET 1 strip / 30 tablets each (Wockhardt Ltd)$ 17.21
Virkil 300 mg x 1 Blister x 10 Tablet
Virkil 300 mg x 3 Blister x 10 Tablet
Zifam Tenovir FC tab 300 mg 6 x 10's (Zifam India)

References

  1. DailyMed. "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Tenofovir disoproxil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Tenofovir disoproxil". http://www.drugbank.ca/drugs/DB00300 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tenvira 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 Tenvira. 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 yet


Consumer reported price estimates

No survey data has been collected yet


2 consumers reported time for results

To what extent do I have to use Tenvira 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 Tenvira. To get the time effectiveness of using Tenvira drug by other patients, please click here.
Users%
1 month1
50.0%
> 3 month1
50.0%


2 consumers reported age

Users%
> 602
100.0%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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