TRUSTIVA TABLETS
Item requires a valid prescription
Manufactured By HETERO HEALTHCARE LTD GENX
Composition EFAVIRENZ 600MG TENOFOVIR 300 MG EMTRICITABINE 200MG
RS 2493.75
MRP RS 3562.50
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Description:
Trustiva Tablet (Efavirenz 600mg + Emtricitabine 200mg + Tenofovir Disoproxil Fumarate 300mg) is a fixed-dose combination antiretroviral tablet manufactured by Hetero Healthcare Ltd Genx, indicated for the treatment of HIV-1 infection in adults. This once-daily triple-drug regimen combines two distinct classes of antiretrovirals: Efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and Emtricitabine plus Tenofovir, two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). Together, they suppress HIV replication from multiple angles, reduce viral load to undetectable levels, preserve CD4 cell count, and slow progression to AIDS. Available from Shabbir Medical Hall at the best price in India, this genuine prescription tablet is available online with fast delivery nationwide.
BENEFITS: Trustiva Tablet provides a clinically proven, WHO-recommended first-line antiretroviral regimen for HIV-1 in a single once-daily pill. The combination reduces pill burden, improves adherence, and has a well-established efficacy and safety profile supported by extensive global clinical data. Efavirenz blocks HIV reverse transcriptase via a non-competitive binding site; Tenofovir and Emtricitabine act as nucleotide/nucleoside analogues that terminate the viral DNA chain — together achieving synergistic viral suppression.
USAGE OVERVIEW: Trustiva Tablet is taken orally, once daily, on an empty stomach or with a light low-fat meal. Taking it at bedtime is recommended to reduce CNS side effects (dizziness, vivid dreams) from Efavirenz. The tablet should be swallowed whole with water; do not crush or chew. Dosage and duration are strictly as prescribed by a registered physician or infectious disease specialist.
SAFETY OVERVIEW: Common side effects include dizziness, insomnia, vivid dreams, rash, nausea, and elevated liver enzymes. Serious effects include hepatotoxicity, psychiatric symptoms (depression, suicidal ideation), severe skin reactions (Stevens-Johnson syndrome), and renal impairment. Regular monitoring of liver function, kidney function, and bone mineral density is recommended. This medicine requires a valid prescription.
Uses / Indications:
- HIV-1 Infection (Treatment): First-line antiretroviral therapy (ART) for adults with HIV-1 infection, in treatment-naïve or virologically stable patients switching regimens
- Prevention of AIDS Progression: Reduces viral load to undetectable, preserves immune function (CD4 count), and lowers the risk of opportunistic infections
ADDITIONAL USES:
- Part of combination ART regimens recommended by WHO, NACO (India), and international HIV treatment guidelines
- Post-exposure prophylaxis (PEP) in certain high-risk situations (as per physician guidance)
Interactions / Warnings:
HEPATOTOXICITY WARNING:
- Liver function tests (ALT, AST, bilirubin) must be monitored before starting therapy and periodically during treatment — especially in patients co-infected with Hepatitis B or C
- Discontinue Trustiva immediately if severe hepatotoxicity occurs (jaundice, elevated transaminases >5x ULN)
- NOTE: Stopping Emtricitabine in HBV co-infected patients may cause acute HBV exacerbation — monitor hepatic function closely after discontinuation
RENAL MONITORING (TENOFOVIR):
- Tenofovir is renally cleared; renal function (eGFR, serum creatinine, urine protein) MUST be assessed before starting and every 3–6 months during treatment
- In renal impairment (CrCl < 50 mL/min): dose adjustment or alternative ART regimen required — consult HIV specialist
- Fanconi syndrome (proximal renal tubular dysfunction) has been reported — monitor serum phosphate and glucose
CNS / PSYCHIATRIC WARNING (EFAVIRENZ):
- Patients with a history of psychiatric illness are at higher risk of serious CNS adverse effects
- Report any new or worsening depression, suicidal thoughts, aggressive behaviour, or psychosis immediately
- Avoid driving or operating heavy machinery until CNS side effects are known to have resolved (usually first 2–4 weeks)
BONE DENSITY (TENOFOVIR):
- Long-term Tenofovir use is associated with decreased bone mineral density — particularly in adults with existing osteoporosis risk factors
- Calcium and Vitamin D supplementation may be recommended by your doctor
FOOD INTERACTION:
- HIGH-FAT meals increase Efavirenz absorption by up to 79%, significantly increasing CNS side effect risk — always take on an empty stomach or with a light low-fat meal
ELDERLY USE (>=65 years):
- Limited clinical data in elderly patients; closer renal, hepatic, and CNS monitoring is recommended
Pregnancy interaction:
- Efavirenz was historically classified as Pregnancy Category D (teratogenic risk in animal studies — neural tube defects); however, recent WHO guidance and large epidemiological studies support its cautious use after the first trimester when benefits outweigh risks
- Trustiva should be avoided in the FIRST TRIMESTER of pregnancy if possible; use only under specialist guidance
- Women of childbearing potential should use effective non-hormonal contraception during therapy (Efavirenz may reduce hormonal contraceptive efficacy) and for 12 weeks after stopping
- Tenofovir and Emtricitabine are generally considered compatible with pregnancy as part of approved PMTCT (Prevention of Mother-to-Child Transmission) regimens
BREASTFEEDING:
- Antiretroviral drugs including Efavirenz, Emtricitabine, and Tenofovir are excreted in breast milk
- WHO recommends that HIV-positive mothers on ART may breastfeed where formula feeding is not safe or feasible, with infant antiretroviral prophylaxis as indicated
- Consult your HIV specialist for individualised breastfeeding guidance
CONTRACEPTION WARNING:
- Efavirenz may reduce plasma levels of hormonal contraceptives (oral pills, implants) — use barrier methods (condom) in addition to hormonal contraception
Expert advice:
1. TAKE AT BEDTIME ON AN EMPTY STOMACH: Trustiva Tablet is best taken at bedtime on an empty stomach or with a light, low-fat snack. Efavirenz causes CNS side effects (dizziness, vivid dreams, difficulty concentrating) within 1–2 hours of dosing — taking it at night means these effects occur during sleep and are far less disruptive to daily life.
2. NEVER SKIP OR STOP WITHOUT SPECIALIST GUIDANCE: HIV antiretroviral therapy must be taken without interruption. Missing doses — even for a short period — causes viral rebound and dramatically increases the risk of drug resistance. If you experience intolerable side effects, contact your HIV specialist immediately rather than stopping independently.
3. USE RELIABLE NON-HORMONAL CONTRACEPTION: Efavirenz significantly reduces the effectiveness of hormonal contraceptives (oral pills, patches, implants, rings). Women of childbearing potential MUST use condoms or a copper IUD in addition to any hormonal method throughout treatment and for at least 12 weeks after stopping Efavirenz.
4. MONITOR MENTAL HEALTH CLOSELY IN THE FIRST MONTH: CNS psychiatric side effects from Efavirenz (vivid dreams, insomnia, depression, unusual thoughts) are most intense in the first 2–4 weeks and typically improve over time. However, report any thoughts of self-harm, severe depression, paranoia, or hallucinations to your doctor immediately — these are medical emergencies.
5. WATCH FOR RENAL WARNING SIGNS: Tenofovir can affect kidney function. Report reduced urine output, persistent ankle swelling, bone pain, muscle weakness, or blood in urine immediately. Keep all kidney function (eGFR, creatinine) test appointments — typically every 3–6 months.
MONITORING ADVICE:
- Liver Function Tests (LFTs: ALT, AST, bilirubin): Baseline, then at 3 months, then every 6 months
- Renal Function (eGFR, serum creatinine, urine protein, phosphate): Baseline, then every 3–6 months
- CD4 count: Every 3–6 months to assess immune recovery
- Viral load (HIV RNA): At 1 month, 3 months, then every 3–6 months — target is undetectable (<20–50 copies/mL)
- Fasting glucose and lipid profile: Baseline, then annually (Efavirenz may affect lipid levels)
- Bone mineral density (DEXA scan): Recommended at baseline, especially in patients with osteoporosis risk factors
- Mental health screening: At every HIV specialist visit
COMPLIANCE TIPS:
- Set a daily phone alarm at the same time each night for your dose
- Keep a simple medication diary noting dose time and any side effects
- Store tablets in original blister strip — protect from heat, moisture, and direct sunlight
- Carry your HIV specialist's prescription and a medication summary card at all times
- Do NOT crush, split, or chew tablets — swallow whole with water
- Take Calcium + Vitamin D supplements if advised (to offset Tenofovir bone effects)
SAFETY TIPS:
- Do NOT stop Trustiva without consulting your HIV specialist — abrupt cessation risks viral rebound and drug resistance
- Maintain all scheduled blood tests and HIV clinic appointments without delay
- Inform ALL treating doctors (GP, dentist, other specialists) that you are on antiretroviral therapy
- Before any surgical procedure, inform the surgeon about your current ART regimen
- In periods of serious illness, contact your HIV specialist regarding continuation of therapy
- HIV is not cured by ART — the virus is suppressed, not eliminated; continue therapy for life as directed
Side Effects:
- CNS Effects (Efavirenz-related): dizziness, insomnia, abnormal dreams/vivid dreams, difficulty concentrating, impaired coordination — usually improve after 2–4 weeks
- Rash: mild-to-moderate maculopapular rash, typically in the first 2 weeks; usually self-limiting
- Nausea, diarrhoea, fatigue
- Elevated liver enzymes (ALT, AST) — especially in patients co-infected with Hepatitis B or C
- Headache, asthenia
SERIOUS SIDE EFFECTS (contact your doctor immediately):
- Psychiatric reactions: severe depression, suicidal ideation, psychosis, aggressive behaviour, paranoia, mania — seek urgent psychiatric review
- Severe skin reactions: Stevens-Johnson syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) — blistering, peeling skin, mucous membrane involvement — DISCONTINUE immediately
- Hepatotoxicity: jaundice, dark urine, severe abdominal pain — STOP drug and seek urgent care
- Lactic acidosis with hepatic steatosis (rare but life-threatening): unusual fatigue, muscle pain, difficulty breathing, cold/numb extremities
- Renal impairment / Fanconi syndrome (Tenofovir-related): decreased urine output, bone pain, muscle weakness
- Bone mineral density loss with long-term Tenofovir use
- Immune Reconstitution Inflammatory Syndrome (IRIS): transient worsening as immune system recovers
EMERGENCY SIGNS — SEEK IMMEDIATE MEDICAL HELP:
- Blistering or peeling skin, mouth ulcers, eye inflammation
- Thoughts of suicide or severe personality change
- Jaundice or severe abdominal pain
- Difficulty breathing with unusual muscle pain and extreme fatigue
How to use:
- HIV-1 Treatment (Adults): ONE tablet (Efavirenz 600mg + Emtricitabine 200mg + Tenofovir 300mg) ONCE DAILY
ROUTE OF ADMINISTRATION:
- Oral (tablet) — swallow whole with water
- Preferably taken ON AN EMPTY STOMACH or with a light low-fat meal
- HIGH-FAT meals significantly increase Efavirenz absorption and risk of CNS side effects — AVOID fatty food around dosing time
TIMING:
- BEDTIME dosing is strongly recommended: CNS side effects (dizziness, vivid dreams, difficulty concentrating) occur within 1–2 hours of dosing and subside during sleep
- Take at the same time each day for consistent plasma drug levels
MISSED DOSE:
- If a dose is missed, take it as soon as you remember — UNLESS it is almost time for the next dose
- Do NOT double the dose to make up for a missed one
- Consistent daily dosing is critical — missed doses risk viral rebound and resistance development
STORAGE:
- Store below 30°C in a dry place, away from moisture and sunlight
- Keep in original blister strip/packaging
- Keep out of reach of children
- Do not use after the expiry date printed on the label
How it works:
- Binds directly and non-competitively to HIV-1 reverse transcriptase
- Blocks the enzyme's ability to convert viral RNA into DNA — a critical step in viral replication
- Does NOT require intracellular phosphorylation (acts directly as a free drug)
MECHANISM OF ACTION — TENOFOVIR DISOPROXIL FUMARATE (NtRTI — Nucleotide Reverse Transcriptase Inhibitor):
- A prodrug converted to tenofovir diphosphate inside cells
- Competes with the natural nucleotide substrate (dATP) and is incorporated into viral DNA
- Lacks a 3'-hydroxyl group — causing premature termination of the viral DNA chain
MECHANISM OF ACTION — EMTRICITABINE (NRTI — Nucleoside Reverse Transcriptase Inhibitor):
- Phosphorylated intracellularly to emtricitabine 5'-triphosphate
- Inhibits HIV reverse transcriptase by chain termination (similar mechanism to Tenofovir)
- Active against both HIV-1 and Hepatitis B virus (HBV)
COMBINED EFFECT:
- Triple-drug synergy ensures viral suppression from multiple sites on the reverse transcriptase enzyme
- Reduces development of drug resistance compared to mono or dual therapy
- Once-daily regimen achieves sustained plasma levels for 24-hour viral suppression
Faq for medicine:
Trustiva contains Tenofovir Disoproxil Fumarate 300mg, Emtricitabine 200mg, and Efavirenz 600mg, a complete once-daily three-drug fixed-dose combination for HIV-1 treatment. Trustiva provides first-line antiretroviral therapy in a single tablet, reducing pill burden for patients. It is a preferred regimen for treatment-naive HIV-positive adults per WHO and national HIV guidelines.
2.How should Trustiva be taken to minimize Efavirenz side effects?
Trustiva should be taken at bedtime on an empty stomach to reduce Efavirenz-related CNS side effects such as dizziness, disturbing dreams, and headaches. These neuropsychiatric effects typically peak in the first 2–4 weeks and improve significantly thereafter. Patients should be counseled before starting Trustiva that early side effects are expected and manageable, preventing unnecessary discontinuation during treatment initiation.
3.What is the impact of Trustiva on HIV viral load in treatment-naive patients?
Trustiva consistently achieves HIV-1 RNA suppression below 50 copies/mL in approximately 70–80% of treatment-naive patients at 48 weeks in clinical trials. Long-term virological durability has been demonstrated over 5 years in adherent patients. Trustiva's efficacy is maintained across various HIV-1 subtypes, with resistance uncommonly developing when patients adhere consistently to the daily single-tablet regimen.
4.Can Trustiva tablets be used in tuberculosis co-infected patients?
Trustiva can be used in HIV-TB co-infected patients receiving Rifampicin-based TB therapy. Efavirenz levels are only modestly reduced by Rifampicin, and no dose adjustment is required in most guidelines. This compatibility is a key advantage of Efavirenz-containing regimens like Trustiva over integrase inhibitors, which require dose doubling with Rifampicin. Close virological monitoring during concurrent therapy is recommended.
5.What happens if Trustiva is taken with a high-fat meal?
Taking Trustiva with a high-fat meal increases Efavirenz bioavailability by up to 39%, significantly worsening CNS toxicity including confusion, severe dizziness, and impaired coordination. Trustiva must always be taken on an empty stomach. This food restriction is a critical patient counseling point that must be addressed at treatment initiation to prevent avoidable adverse effects.
6.Does Trustiva require dose adjustment in patients with liver disease?
Trustiva's Efavirenz component is hepatically metabolized and should be used with caution in mild to moderate liver disease. In severe hepatic impairment (Child-Pugh C), Trustiva is contraindicated due to risk of Efavirenz accumulation and toxicity. HBV and HCV co-infection with liver disease must be carefully evaluated before initiating Trustiva. Emtricitabine and TDF require renal rather than hepatic dose adjustment.
Medicine interaction:
- Strong CYP3A4 / CYP2B6 inducers (rifampicin, carbamazepine, phenytoin, phenobarbitone, St John's Wort): significantly reduce Efavirenz plasma levels — AVOID or adjust dose under specialist guidance
- Strong CYP3A4 inhibitors (ritonavir, atazanavir, clarithromycin, ketoconazole): may increase Efavirenz levels and toxicity — use with caution; dose adjustment may be required
- Drugs with nephrotoxic potential (NSAIDs, aminoglycosides, cidofovir, IV contrast agents): increase Tenofovir-related renal toxicity risk — monitor closely
- Metformin: Tenofovir may increase metformin plasma levels; monitor for lactic acidosis risk
- Warfarin / anticoagulants: Efavirenz affects CYP2C9 — monitor INR closely
- Hormonal contraceptives (oral pills, implants, rings): Efavirenz reduces their efficacy — additional contraception required
- Statins (simvastatin, atorvastatin): Efavirenz reduces statin plasma levels — dose adjustment may be needed
- Other antiretrovirals: consult HIV specialist before combining with other ARTs
VACCINE INTERACTIONS:
- Consult your HIV specialist before any vaccinations during ART
SUPPLEMENT INTERACTIONS:
- St John's Wort: potent CYP3A4/CYP2B6 inducer — CONTRAINDICATED with Efavirenz
- Always inform your doctor of all vitamins, herbal products, and supplements
