Darunavir, cobicistat, emtricitabine, and Viread 123mg 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 Viread 123mg alafenamide is usually given to patients who have yet not received any medicine for HIV infection.
Darunavir, cobicistat, emtricitabine, and Viread 123mg 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 Viread 123mg alafenamide will not keep you from spreading HIV to other people. People who receive darunavir, cobicistat, emtricitabine, and Viread 123mg alafenamide may continue to have other problems usually related to AIDS or HIV disease.
Darunavir, cobicistat, emtricitabine, and Viread 123mg alafenamide is available only with your doctor's prescription.
Viread 123mg indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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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 Viread 123mg for the treatment of HIV-1 infection: Viread 123mg should not be used in combination with (Viread 123mg 300 mg + emtricitabine 200 mg) or (efavirenz + emtricitabine + Viread 123mg).
Treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Viread 123mg 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 Viread 123mg?
Use Viread 123mg powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Viread 123mg powder. Talk to your pharmacist if you have questions about this information.
Take Viread 123mg powder by mouth with food as directed.
Only use the dosing scoop that comes with Viread 123mg 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 Viread 123mg 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 Viread 123mg 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 Viread 123mg powder even if you feel well. Do not miss any doses.
Taking Viread 123mg powder at the same time each day will help you remember to take it.
Do not suddenly stop taking Viread 123mg 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 Viread 123mg powder.
If you miss a dose of Viread 123mg 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 Viread 123mg powder.
Uses of Viread 123mg in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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, Viread 123mg 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, Viread 123mg (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.
Viread 123mg description
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Viread 123mg disoproxil fumarate (a prodrug of Viread 123mg), 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 Viread 123mg disoproxil fumarate is converted to Viread 123mg, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.
Prior to or when initiating Viread 123mg, test patients for hepatitis B (HBV) virus infection.
Prior to or when initiating Viread 123mg, and during treatment with Viread 123mg, 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
Viread 123mg 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 Viread 123mg alafenamide (TAF). The recommended dosage of Viread 123mg is one tablet taken orally once daily with food in adults. For patients who are unable to swallow the whole tablet, Viread 123mg 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
Viread 123mg is not recommended in patients with creatinine clearance below 30 mL per minute.
Not Recommended in Patients with Severe Hepatic Impairment
Viread 123mg is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
Not Recommended During Pregnancy
Viread 123mg is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
Viread 123mg should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with Viread 123mg.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
More about Viread 123mg (cobicistat / darunavir / emtricitabine / Viread 123mg alafenamide)
Acyclovir-Valacyclovir: May increase the serum concentration of Viread 123mg Products. Viread 123mg Products may increase the serum concentration of Acyclovir-Valacyclovir. Monitor therapy
Adefovir: May diminish the therapeutic effect of Viread 123mg Products. Adefovir may increase the serum concentration of Viread 123mg Products. Viread 123mg Products may increase the serum concentration of Adefovir. Avoid combination
Aminoglycosides: May increase the serum concentration of Viread 123mg Products. Viread 123mg Products may increase the serum concentration of Aminoglycosides. Monitor therapy
Atazanavir: Viread 123mg Disoproxil Fumarate may decrease the serum concentration of Atazanavir. Atazanavir may increase the serum concentration of Viread 123mg Disoproxil Fumarate. Management: Must use boosted atazanavir in adults; give combo (atazanavir/ritonavir or atazanavir/cobicistat with Viread 123mg) as a single daily dose with food. Pediatric patients, pregnant patients, and users of H2-blockers require other dose changes. Consider therapy modification
Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy
Cidofovir: May increase the serum concentration of Viread 123mg Products. Viread 123mg Products may increase the serum concentration of Cidofovir. Monitor therapy
Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Avoid combination
Cobicistat: May enhance the adverse/toxic effect of Viread 123mg Products. More specifically, cobicistat may impair proper Viread 123mg monitoring and dosing. Monitor therapy
Darunavir: Viread 123mg Disoproxil Fumarate may increase the serum concentration of Darunavir. Darunavir may increase the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
Diclofenac (Systemic): May enhance the nephrotoxic effect of Viread 123mg Products. Management: Seek alternatives to this combination whenever possible. Avoid use of Viread 123mg with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification
Didanosine: Viread 123mg Disoproxil Fumarate may diminish the therapeutic effect of Didanosine. Viread 123mg Disoproxil Fumarate may increase the serum concentration of Didanosine. Management: Avoid use of Viread 123mg disoproxil fumarate and didanosine when possible. If combined in adults with CrCL greater than 60 mL/min, decrease didanosine to 250 mg daily if 60 kg or more or to 200 mg if less than 60 kg. Avoid if CrCL is less than 60 mL/min. Consider therapy modification
Ganciclovir-Valganciclovir: Viread 123mg Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Viread 123mg Products. Monitor therapy
Ledipasvir: May increase the serum concentration of Viread 123mg Disoproxil Fumarate. Management: Avoidance of this combination is recommended under some circumstances. Refer to full monograph for details. Consider therapy modification
Lopinavir: May enhance the nephrotoxic effect of Viread 123mg Disoproxil Fumarate. Lopinavir may increase the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of Viread 123mg Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of Viread 123mg with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy
Simeprevir: Viread 123mg Disoproxil Fumarate may decrease the serum concentration of Simeprevir. Simeprevir may increase the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
Tipranavir: Viread 123mg Disoproxil Fumarate may decrease the serum concentration of Tipranavir. Tipranavir may decrease the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
Velpatasvir: May increase the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
Voxilaprevir: Viread 123mg Disoproxil Fumarate may increase the serum concentration of Voxilaprevir. Voxilaprevir may increase the serum concentration of Viread 123mg Disoproxil Fumarate. Monitor therapy
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 Viread 123mg 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 Viread 123mg once daily and 363 subjects received a combination of PREZCOBIX® (fixed-dose combination of darunavir and cobicistat) and fixed-dose combination of emtricitabine and Viread 123mg disoproxil fumarate (FTC/TDF).
The proportion of subjects who discontinued treatment with Viread 123mg 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 Viread 123mg and those receiving PREZCOBIX and F/TDF are presented in Table 3.
Most adverse reactions during treatment with Viread 123mg were grade 1 or 2 in severity. One grade 3 reaction was reported and no grade 4 adverse reactions were reported during treatment with Viread 123mg.
Table 1: Adverse Reactions Reported in ≥2% of HIV-1 Infected Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
Adverse Reactions in Virologically-Suppressed Adults
The safety profile of Viread 123mg 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 Viread 123mg, and 378 subjects who continued their treatment regimen of a boosted protease inhibitor with FTC and TDF. Overall, the safety profile of Viread 123mg 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 Viread 123mg 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 Viread 123mg, or are from studies described in the prescribing information of the individual component PREZISTA (darunavir).
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
Viread 123mg
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 Viread 123mg 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)*
Viread 123mg
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 Viread 123mg, 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 Viread 123mg, 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 Viread 123mg 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 (Viread 123mg) and 118 mL/min (PREZCOBIX + FTC/TDF), mean (SD) serum creatinine increased by 0.05 (0.10) mg/dL in the Viread 123mg 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 (Viread 123mg) and 0.89 mg/dL (PREZCOBIX + FTC/TDF) at baseline and 0.95 mg/dL (Viread 123mg) 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 (Viread 123mg) and 51 mg/g (PREZCOBIX + FTC/TDF) at baseline and 30 mg per gram (Viread 123mg) 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 (Viread 123mg) and 103 mL/min (bPI+FTC/TDF) who were randomized to continue their treatment regimen or switch to Viread 123mg, at Week 48, mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to Viread 123mg. Mean (SD) serum creatinine was 0.98 (0.18) mg/dL (Viread 123mg) and 0.98 (0.19) mg/dL (bPI+FTC/TDF) at baseline and 0.99 (0.18) mg/dL (Viread 123mg) and 0.99 (0.21) mg/dL (bPI+FTC/TDF) at Week 48. Median serum creatinine was 0.97 mg/dL (Viread 123mg) and 0.98 mg/dL (bPI+FTC/TDF) at baseline and 1.0 mg/dL (Viread 123mg) and 0.97 mg/dL (bPI+FTC/TDF) at Week 48. Median UPCR was 62 mg per gram (Viread 123mg) and 63 mg/g (bPI+FTC/TDF) at baseline and 37 mg per gram (Viread 123mg) and 53 mg/g (bPI+FTC/TDF) at Week 48.
Bone Mineral Density
AMBER
The effects of Viread 123mg 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 Viread 123mg 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 Viread 123mg subjects and 22% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by 2% of Viread 123mg 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 Viread 123mg; 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 Viread 123mg 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 Viread 123mg subjects and 9% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by no Viread 123mg 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.
Viread 123mg is contraindicated with the following co-administered drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect.
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