Reviro

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Reviro

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Reviro

Property Description
Active ingredient Tenofovir Disoproxil Fumarate (TDF)
Form Film-coated tablet (Oral)
Pharmacological class Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NRTI/NtRTI)
General purpose Viral suppression
Origin Synthetic, Acyclic nucleoside phosphonate analog

What Type of Medicine is Reviro?

Reviro is a synthetic, prescription-only medicine and a leading brand containing the active substance Tenofovir Disoproxil Fumarate (TDF), which is an acyclic nucleoside phosphonate analog. It is primarily classified as an Antiviral for Systemic Use and, more specifically, a Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NRTI/NtRTI).

TDF acts as a crucial agent for inhibiting key viral enzymes, thereby limiting the replication of serious systemic viruses. This specific class of compounds is utilized for achieving sustained viral control, making it a widely used medicine in global public health.

What is Reviro Made Of and How Does it Function?

Reviro is delivered as a solid, oral film-coated tablet, with the Tenofovir Disoproxil Fumarate acting as a prodrug that is activated only after absorption into the body. Its primary general purpose is to achieve sustained viral suppression, a critical goal in the ongoing management of chronic viral diseases.

The active component structurally mimics a natural genetic building block; when incorporated into the viral DNA chain, it causes immediate genetic chain termination. This highly specific action is the basis for the medicine’s ability to significantly reduce the overall viral load and limit the spread of the infection within the body.

Distinction: TDF as a Prodrug

The chemical engineering of Tenofovir Disoproxil Fumarate as a prodrug is essential for its therapeutic effectiveness. This structural modification enhances the drug's absorption and allows for its efficient conversion into the active compound, Tenofovir, ensuring that sufficient levels reach the cells necessary to execute the targeted antiviral function. TDF is characterized by a favorable pharmacological profile, which allows for convenient once-daily oral dosing (usage instructions are detailed elsewhere).

What side effects are possible with Reviro?

Possible Side Effects and Safety Information

The official safety profile for Reviro (Tenofovir Disoproxil Fumarate) is characterized by classifying adverse reactions based on their frequency and the physiological system they affect, as documented in government regulatory sources.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped into categories based on occurrence in clinical trials:

  • Very Common (1/10): Gastrointestinal reactions such as nausea, diarrhea, vomiting, abdominal pain, and flatulence. Other very common effects include headache, dizziness, and low blood phosphate levels (hypophosphatemia).
  • Common (1/100 to < 1/10): Fatigue, rash, abdominal distension, and peripheral neuropathy.
  • Uncommon (1/1,000 to < 1/100): Pancreatitis, low blood potassium (hypokalemia), and acute renal failure.
  • Rare (1/10,000 to < 1/1,000): Lactic acidosis (a rare, potentially life-threatening buildup of acid in the blood) and osteomalacia (softening of the bone).

Serious Adverse Reactions and Safety Constraints

The regulatory label highlights several clinically significant, though less frequent, safety concerns:

  • Systemic Risks: Serious reactions include the rare occurrences of Lactic Acidosis and Severe Hepatomegaly with Steatosis (enlarged liver with fatty deposits).
  • Renal and Bone Effects: The medicine is associated with the potential for new onset or worsening renal impairment, which can include acute renal failure and Fanconi Syndrome. Bone mineralization defects and decreases in bone mineral density are also documented risks, particularly with long-term exposure.
  • Post-Treatment Risk: In patients treated for chronic Hepatitis B Virus (HBV) infection, the regulatory label notes the risk of a severe acute exacerbation of Hepatitis B upon the discontinuation of the medicine.

Specific safety statements exist for special populations, including required assessment and monitoring of renal function (creatinine clearance and serum phosphorus) before and during therapy, and noting potential risks in pediatric subjects.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Reviro (Tenofovir Disoproxil Fumarate) addresses overdose by focusing on the risk of severe, life-threatening drug toxicity syndromes.

Manifestations and Severe Outcomes

An overdose may result in clinical or laboratory findings suggestive of Lactic Acidosis or Severe Hepatomegaly with Steatosis (enlarged liver with fatty change). These conditions are considered potentially life-threatening outcomes. Symptoms of acute toxicity that require immediate attention often align with Lactic Acidosis and include unusual muscle pain, severe stomach discomfort with or without nausea, weakness, and difficulty breathing or rapid respiration. The risk of toxicity is significantly increased in patients with existing renal impairment due to decreased drug clearance.

Emergency Actions and Management

If an overdose is suspected, official guidance mandates that individuals seek immediate medical help. This requires calling emergency services or a Poison Control center, or proceeding to the nearest hospital emergency room. Treatment is primarily supportive as no specific antidote is known. Medical management focuses on providing standard supportive treatment and continuous monitoring for evidence of toxicity. Regulatory information notes that hemodialysis is an available procedural measure that can remove a significant portion of the drug.

Therapeutic Uses of Reviro

What Reviro Treats: Main Uses and Benefits

Reviro (Tenofovir Disoproxil Fumarate) is commonly used to manage persistent, chronic viral diseases. Its therapeutic value is relevant for controlling the underlying infection to assist with preventing progressive damage and long-term decline in health. This medicine is indicated for the treatment of both chronic Human Immunodeficiency Virus type 1 (HIV-1) infection and chronic Hepatitis B Virus (HBV) infection.


Key Therapeutic Applications

Reviro is often applied in therapeutic regimens for two primary conditions: HIV-1 infection and chronic HBV infection. Its use is relevant for suppressing the viral load, which in turn helps limit the progressive destruction of immune cells and assists with managing the overall viral burden. The goal is focused on symptoms that interfere with daily functioning and symptoms linked to organ-specific functional stress.

Focus on Benefits and Patient Groups

In the context of HIV-1, the medication supports the maintenance of immune system function, helping to reduce the potential for severe, opportunistic illnesses. For chronic HBV, Reviro supports the easing of inflammatory processes and may contribute to limiting further liver damage, which supports the reduction of the potential risk for developing serious long-term conditions like cirrhosis. It is commonly used in adults and specific pediatric patient groups (typically 2 years of age) and is considered relevant for patients managing co-infection with both viruses.

Quick Fact: Relief for Viral Suppression

Reviro's use is crucial for reducing the viral load, which is the necessary step for the body to maintain stability and prevent the escalation of symptoms related to systemic imbalance.

Eligibility and Restrictions for Use

Eligibility for Reviro (Tenofovir Disoproxil Fumarate, TDF) is strictly defined by official regulatory criteria and includes specific rules concerning age, weight, and existing health conditions, as documented by authorities such as the FDA and EMA.

Contraindications and Restrictions

Classification Rule
Absolute Contraindication Patients with known hypersensitivity to Tenofovir Disoproxil Fumarate or any component of the formulation [2.4].
Co-administration Restriction Must not be used alongside other medicines containing tenofovir (such as TAF products) or the related drug Adefovir Dipivoxil [1.3].

Age and Condition-Specific Eligibility

  • Adults are approved for the treatment of chronic HIV-1 and chronic HBV infection [1.2].
  • Pediatric Use is established only for patients ge 2 years of age weighing at least 10 kg [1.2]. Use in infants or children under these thresholds is not established.
  • Renal Impairment defines major limits: use is generally not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min) or those on hemodialysis, as safe dose adjustment for the standard tablet strength is not possible [2.2].
  • Pregnancy and Lactation information is documented by regulators: while data suggest TDF may be used during pregnancy [3.1], breastfeeding is not recommended for mothers with HIV to prevent viral transmission [1.3].

What should I know about interactions with other medicines?

Reviro Interactions with Other Medicines and Products

The interaction profile for Reviro (Tenofovir Disoproxil Fumarate, TDF) is based on pharmacokinetic and pharmacodynamic relationships defined in regulatory documents.


Formal Contraindications and Restrictions

Classification Interacting Agent(s)
Prohibited Adefovir Dipivoxil (HEPSERA)
Prohibited Other Tenofovir-containing products (e.g., combination products)
Avoid Use Nephrotoxic drugs (concurrent or recent use)

These prohibitions are mandated in the regulatory labeling to prevent drug duplication and additive risk of adverse events [Source 2.1, 2.6]. Use with nephrotoxic agents is strongly advised against due to the risk of worsening renal impairment [Source 2.1].

Clinically Significant Pharmacokinetic Interactions

Reviro's elimination is primarily via active renal tubular secretion. Co-administration with agents that compete for this pathway or that reduce renal function may increase Tenofovir concentrations [Source 1.4].

Interacting Agent(s) Official Resulting Change
Boosted Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir) Increases Tenofovir concentrations (AUC and Cmin)
Didanosine (ddI) Increases Didanosine concentrations
Certain HCV Antivirals (e.g., Ledipasvir/Sofosbuvir) Increases Tenofovir concentrations

Co-administration with unboosted Atazanavir officially decreases Atazanavir concentrations, making the combination unsuitable [Source 2.1]. The increased exposure of Tenofovir due to interactions is of particular concern in populations with renal impairment (CrCl < 50 mL/min) [Source 2.2].

Mechanism of Action

Targeting Viral Enzyme Synthesis: Competitive Inhibition

The mechanism begins with the conversion of the medicine into its active compound, Tenofovir Diphosphate (TFV-DP), inside the cell. TFV-DP acts as a structural mimic of the natural DNA building block (dATP), allowing it to competitively inhibit the Viral Reverse Transcriptase/Polymerase enzyme. By occupying the enzyme's active site, the molecule prevents the natural building block from binding, which initiates interference with viral DNA synthesis.


Obligate DNA Chain Termination

The next step describes the cascade that influences viral proliferation. Once the active compound is incorporated into the growing viral DNA chain, its unique chemical structure terminates the synthesis immediately and irreversibly. The absence of complete viral genetic material limits the assembly of new, infectious particles. The physiological consequence of this strict molecular block is a systemic reduction in the viral load.


️ Constraints and Selectivity of the Mechanism

This domain addresses the factors that govern the mechanism's activity. The molecule exhibits greater selectivity for viral polymerases than human polymerases, but its function is intrinsically linked to the host cell's ability to activate it (intracellular phosphorylation). The mechanism is constrained by the virus's high mutation rate, which can lead to specific enzyme changes that reduce its binding affinity for the active drug, thus limiting the resulting systemic reduction of the viral population.

Dosage and Administration Information

How to Use Reviro: Official Administration Guidelines

Reviro, containing Tenofovir Disoproxil Fumarate (TDF), is administered according to standardized protocols to ensure correct systemic exposure. The medicine is designed for oral administration and is generally taken once daily, with specific adjustments required for certain populations and formulations.


Core Administration Schedule

Instruction Detail
Standard Dosing 300 mg once daily for adults and pediatric patients weighing ge 35 kg.
Dosing Frequency Once daily administration (qDay) is the standard regimen across all approved uses.
Timing with Food Film-coated tablets can be taken without regard to food. The oral powder formulation must be taken with food.
Combination Use For the treatment of HIV-1, Reviro must be used in combination with other antiretroviral agents.

Special Handling and Population-Specific Rules

Usage instructions are modified for individuals with renal impairment and for younger patients. For individuals with moderate renal impairment, the dosing interval is extended to 300 mg every 48 hours. Further interval adjustments (e.g., every 72 to 96 hours) are necessary for more severe impairment.

Pediatric dosing is based on body weight for children ge 2 years of age and ge 10 kg, with the daily dose not exceeding 300 mg. The oral powder must be mixed only with a small amount of soft food (not liquid) and consumed immediately.

If a dose is missed, it should be taken the same day as soon as remembered; however, two doses must not be taken together. Treatment for chronic viral conditions typically constitutes a long-term plan, requiring continuous administration.

Recent Clinical Evidence

Reviro: Recent Clinical Evidence

Evidence for Use in Chronic HIV-1 Infection

The evidence for Reviro in chronic HIV-1 infection relies on major Randomized Controlled Trials (RCTs) and long-term cohort studies. These studies, involving both treatment-naïve and experienced adults, explore its use as a component of combination therapy. Researchers primarily monitored virological outcomes (HIV-1 RNA suppression) and immunological outcomes (CD4+ T-cell counts). The studies reported that participants receiving regimens containing Reviro maintained measurements of HIV-1 RNA suppression and described patterns where CD4+ T-cell counts were observed to increase. However, data on long-term immunological outcomes and use in certain patient subgroups with complex health conditions remains limited.


Evidence for Use in Chronic Hepatitis B Virus (HBV) Infection

The research base for chronic HBV infection is built upon controlled trials that explored how the medicine was associated with changes in patients who are HBeAg-positive and HBeAg-negative. Studies focused on HBV DNA suppression and the normalization of liver enzyme levels. Trials reported measurements of HBV DNA suppression, and researchers monitored for patterns related to HBeAg loss. Long-term extension studies track the durability of these observations over five to seven years, including related histological changes in the liver. Research data remains insufficient for patients with advanced decompensated liver disease.


Evidence in Special Populations and Research Gaps

Research has evaluated Reviro in specific pediatric populations (typically 2 years of age) and in patients with a co-infection of both HIV-1 and HBV, exploring patterns related to simultaneous viral suppression. A key limitation across the research base is that the follow-up durations were limited in the initial controlled trials. Consequently, long-term effects are not fully established or characterized for every patient subgroup, and the results apply only to the specific conditions and populations studied.

Frequently Asked Questions (FAQ)

Common questions about Reviro (FAQ)

Q: What happens if I miss a dose of Reviro?

If a dose is missed, official prescribing information states that the dose may be taken as soon as it is remembered, provided it is still on the same day. If it is almost time for the next scheduled dose, the missed dose should be skipped entirely. Regulatory guidelines indicate that two doses must not be taken together.

Q: What is the maximum amount of time Reviro can be safely stored at room temperature?

The film-coated tablets should generally be kept at controlled room temperature. Official regulatory instructions specify that this temperature range is typically between 15 C and 30 C (59 F and 86 F). Specific instructions for storage and protection from heat and moisture are detailed on the product packaging.

Q: Are there any foods or vitamins I should avoid while on Reviro?

Official product information primarily focuses on drug-to-drug interactions, particularly with other medicines that affect the kidneys or contain related antiviral agents. The label does not list any specific common foods or vitamins that must be avoided while taking this medication.

Q: What are the signs and symptoms of kidney problems I should watch out for?

Studies and official information indicate that this medication is associated with a risk of new or worsening kidney impairment. Possible signs that may indicate a kidney issue include a noticeable decrease in the amount of urine produced or swelling in the ankles, feet, or hands. Regulatory information recommends that a healthcare provider monitor kidney function regularly during treatment.

Q: Is Reviro a brand name or a generic medicine?

Reviro is a brand name medication. The active ingredient it contains is Tenofovir Disoproxil Fumarate. Like many medications, the active ingredient is also available from other manufacturers as a generic option.

Q: Does Reviro come in different strengths?

The active ingredient Tenofovir Disoproxil Fumarate is available in various strengths for oral use, including 150 mg, 200 mg, 250 mg, and 300 mg film-coated tablets. The specific strength used is determined by the prescribing healthcare provider.

Q: What should I do if I have an allergic reaction to Reviro?

Official information states that a known hypersensitivity to the drug is a contraindication, meaning it should not be used. If signs of a severe allergic reaction occur, such as a widespread rash, hives, swelling of the face, lips, tongue, or difficulty breathing, immediate emergency medical attention is required.

Q: How long does it take for Reviro to start working?

The medication is designed to be absorbed quickly after it is taken, with the highest concentration in the blood typically reached in about one hour. The full clinical effectiveness, indicated by a sustained reduction in the viral load, is typically monitored over a period of weeks to months.

Q: Is Reviro available as an injection?

No, according to the official product information, Reviro is not available as an injection. The approved dosage forms for this medicine are a film-coated tablet for oral use and an oral powder.

Q: When did Reviro first get approved by the FDA?

The brand-name product containing Tenofovir Disoproxil Fumarate was first approved by the U.S. Food and Drug Administration (FDA) on October 26, 2001.

How should Reviro be stored and disposed of?

How to Store and Dispose of Reviro

Official regulatory guidelines strictly define the conditions necessary to maintain the quality and integrity of this medication.

Storage Requirements

Condition Requirement
Temperature Store in a refrigerator between 2 C and 8 C (36 F and 46 F).
Protection Keep the vial or syringe in the original outer carton to protect the product from light.
Prohibition Do not freeze. The product must be discarded if it has been frozen.

Stability and Handling

Once the product is reconstituted or prepared for use, official instructions mandate that it be used immediately. If immediate use is not possible, a strict in-use stability limit (e.g., 4 hours at 30 C) applies, depending on the specific product formulation. Always visually inspect the product before use.

Disposal Instructions

Any unused portion of Reviro, waste materials, and used components must be discarded precisely in accordance with local regulatory requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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