Naivex

Naivex 50 mg (Dolutegravir) is an HIV-1 integrase protein inhibitor indicated against human immunodeficiency virus (HIV) type 1 infection. It is preferred to be taken with other anti-retroviral options for better results.  Naivex 50 mg (Dolutegravir) preferentially inhibits HIV DNA integration by replacing integrase enzyme (a type of protein) in the chain which blocks the multiplication (replication) of viral cells.

The mechanism allows Naivex 50 mg (Dolutegravir) to render a stronger immune system for decreasing the viral load, incidence of HIV-related complications, and events of new infections. Naivex 50 mg (Dolutegravir) can be taken with or without food either once daily or twice daily based on the requirements. The following table shows the recommended dosage regimen based on the population.

Table: Recommended dosage regimen of Naivex 50 mg (Dolutegravir):

Population	Age group	Dosage
Therapy-naïve	Adults	50 mg once daily (1 tablet)
Therapy-experienced but INSTI-naïve
Virologically suppressed		Naivex 50 mg (Dolutegravir) + Rilpivirine 25 mg
Therapy-naïve	Adults	50 mg twice daily (2 tablets)
Therapy-experienced but INSTI-naïve when co-administered with other drugs
INSTI-experienced with suspected or proven INSTI-resistance
Patients with body-weight of 40 kgs or greater	Children	50 mg once daily (1 tablet)

Note:

1. Therapy-naïve: Patients who have not taken any medicines for HIV-1 infection
2. Therapy-experienced: Patients who might have taken some medicines for HIV-1 infection before Naivex 50 mg (Dolutegravir)
3. INSTI-naïve: Patients who have not received integrase strand transfer inhibitor (INSTI) therapy
4. INSTI-experienced: Patients who have received INSTI therapy before Naivex 50 mg (Dolutegravir)

After ingestion, Naivex 50 mg (Dolutegravir) get rapidly absorbed in the system within 2 to 3 hours. The binding rate with viral cells is 98.9% and to reach a steady-state, it takes around 5 days after initiation of dosing. Subsequently, Naivex 50 mg (Dolutegravir) takes around 14 hours (50%) to expel out of the system.

Side-effects and warnings associated with Naivex 50 mg (Dolutegravir):

Naivex 50 mg (Dolutegravir) has minimal after-effects on human host cells which helps in attaining excellent tolerability and minimal toxicity. However, certain complications might show other side-effects requiring immediate consultation. These include,

Hypersensitivity (allergy) reactions: 

Rashes with side-effects like,

• Fever
• General illness
• Extreme tiredness (Fatigue)
• Pain in the muscles and joints
• Skin and oral blisters or peelings
• Eye inflammation
• Swelling of face

Hepatotoxicity: Toxicity of the liver

Liver problems (Hepatitis B or C) with side-effects like:

• Nausea
• Vomiting
• Pain and sensitivity on the right side below the ribs
• Jaundice
• Abnormal colour of the urine, stool and bowel movements
• Loss of appetite

Immune reconstitution syndrome occurring due to inflammation from previous infections due to other antiretrovirals.

Most common side-effects:

• Difficulty in sleeping (Insomnia)
• Tiredness (Fatigue)
• Headache

Note: These are not all possible side-effects of Naivex 50 mg (Dolutegravir), please ask your doctor for additional info.

General warnings related to embryo-fetal toxicity and pregnancy:

• Discuss the pregnancy plans with your healthcare provider as the drug has the potential to harm the fetus
• Avoid using the drug at the first trimester of pregnancy
• Strictly use effective contraceptive methods if patients are undergoing Naivex 50 mg (Dolutegravir) therapy