Health and Me

Rachel V Thomas

Tivicay: US FDA Approves Drug to Treat HIV In Newborns

Tivicay: US FDA Approves Drug to Treat HIV in Newborns

The US Food and Drug Administration (FDA) has approved <span>Tivicay</span> PD tablets for oral suspension (<span>dolutegravir</span>) to treat <span>HIV</span> infection in babies.

Developed by ViiV Healthcare, Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

Now, Tivicay PD has been approved for newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents.

Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor used in combination with other antiretroviral agents to treat HIV.

Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle.

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/us-measles-outbreak-pennsylvania-reports-first-deaths-of-2026-as-trump-pushes-back-on-vaccines-article-155985621" data-type="tilCustomLink">US Measles Outbreak: Pennsylvania Reports First Deaths Of 2026 As Trump Pushes Back On Vaccines</a>

<h2>What’s The Evidence For Tivicay PD In Newborns?</h2>

The FDA approval was based on data from the IMPAACT 2023 study, in which 48 newborns exposed to HIV-1 and weighing at least 2 kg received Tivicay PD from birth for up to six weeks, in combination with standard-of-care antiretroviral medications to prevent mother-to-child HIV transmission.

The newborns were followed for 16 weeks. Results showed that Tivicay PD drug levels in newborns were similar to those associated with efficacy in adults.

Importantly, the drug’s safety profile in newborns was also similar to that observed in older pediatric and adult patients.

<strong>Read More: </strong><a href="https://www.healthandme.com/health-wellness/reducing-mother-to-child-hiv-transmission-to-zero-key-to-end-aids-in-india-experts-article-153769494" data-type="tilCustomLink">Reducing Mother-To-Child HIV Transmission To Zero Key To End AIDS In India: Experts</a>

In June, the FDA accepted a supplemental new drug application (sNDA) for Tivicay PD that would extend its use to newborns from birth. The agency granted the application Priority Review with a PDUFA action date of August 25, 2026.

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," said Jean van Wyk, chief medical officer at ViiV Healthcare, at the time.

<h2>Who Should Avoid Tivicay or Tivicay PD?</h2>

Patients should not receive Tivicay or Tivicay PD if they have had previous allergic reactions to the drug or if they are also receiving dofetilide.

Serious allergic reactions have been reported. Patients should be monitored for liver damage. Immune reconstitution syndrome has also been reported in patients treated with combination antiretroviral therapy.

Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects. Patients or their caregivers should tell their healthcare provider about all medications they are taking before starting Tivicay or Tivicay PD.

Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.

HIV (human immunodeficiency virus) attacks the body's immune system, increasing the chances of developing serious infections or cancer. Without treatment, HIV can lead to AIDS (acquired immunodeficiency syndrome).

There is no cure for HIV, but prevention and treatment options are available.

<h2>Preventing Mother-to-Child HIV Transmission</h2>

Pediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. The latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life. 

Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals, according to UNAIDS.

An HIV-positive mother can pass the virus to her baby during pregnancy, labor, delivery, or breastfeeding, but proper medical care lowers this risk to less than 1%.

Health Conditions A-Z

health

tivicay-us-fda-approves-drug-to-treat-hiv-in-newborns

Tivicay

dolutegravir

US FDA

HIV in babies

HIV in Newborns

three-deaths-in-chinese-gene-therapy-trials-raise-safety-concerns-experimental-treatments-under-scrutiny

Three Deaths In Chinese Gene Therapy Trials Raise Safety Concerns: Experimental Treatments Under Scrutiny

1-in-4-former-nfl-players-had-cte-at-death-effects-of-repeated-head-trauma-does-to-the-brain

1 In 4 Former NFL Players Had CTE At Death: Effects Of Repeated Head Trauma Does On The Brain

Health News

8 Sit-Up Variations to Strengthen Your Core and Build Stability

Benefits Of Ayurvedic Health Supplement Ashwagandha

9 Anti-Inflammatory Breakfast Options You Should Try

5 Foods You Should Avoid For PCOS, Says Gynecologist

Love Sitting With Your Legs Crossed? Here’s You Should Avoid It

6 Daily Foods That Are Secretly Increasing Your Calories

9 Brain Boosters You Should Do Everyday

Hip Exercises That Will Keep You Flexible As You Age

9 Leg Exercises Office Workers’ Should Do At Home

Benefits of Having Herbal Tea Every Morning

9 Daily Habits That Boost Your Brain Power

Lower-Body Exercises That Are Game-Changers

How Drinking Apple Cider Vinegar Helps You

Aging Myths You Should Never Believe

Superfoods That Support Your Gut Health

What Happens To Your Body When You Eat Instant Noodles Every Day?

Health Issues Premature Babies Often Face

Exercises Office Workers Should Do For Their Heart Health

Reasons Why You Should Add Raw Turmeric To Your Diet

Benefits Of Drinking Milk At Night: Why You Should Do It

Food That Provides Vitamin B12 Naturally In Your Diet

Surprising Health Benefits Of Fenugreek Seeds

9 Superfoods You Should Eat For Your Brain Health

What Does Mental Health Support Look Like At Work?

Long Stretches You Should Do To Unwind From Your Day

Colon Cancer In Young Adults: Early Symptoms You Should Know

Health Benefits Of Eating Dry Fruits Everyday

Are You At Risk For Fried Rice Syndrome?

These Tests Reveal How Well You Are Aging

Lower-Back Exercises You Should Do After A Long-Day's Work

Children’s Diet – What Kids Need To Eat For Immunity Building

Common Diabetes Myths That Could Hurt Your Health

Love Spicy Food? Here’s How It Affects Your Health

Superfood List: Veggies And Fruits You Must Have For Immunity

Foods People With IBS Should Avoid

Exercises To Improve Digestion

Easy Work Lunches You Can Make In The Morning

Hunger Vs Craving: Difference Explained In 60 seconds

These Things Can Cause Your Heart To Age Faster

High Carb Foods That Are Actually Healthy

The US Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies.Developed by ViiV Healthcare, Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.Now, Tivicay PD has been approved for newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents.How Does Tivicay Work?Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor used in combination with other antiretroviral agents to treat HIV.Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle.Also read: US Measles Outbreak: Pennsylvania Reports First Deaths Of 2026 As Trump Pushes Back On VaccinesWhat’s The Evidence For Tivicay PD In Newborns?The FDA approval was based on data from the IMPAACT 2023 study, in which 48 newborns exposed to HIV-1 and weighing at least 2 kg received Tivicay PD from birth for up to six weeks, in combination with standard-of-care antiretroviral medications to prevent mother-to-child HIV transmission.The newborns were followed for 16 weeks. Results showed that Tivicay PD drug levels in newborns were similar to those associated with efficacy in adults.Importantly, the drug’s safety profile in newborns was also similar to that observed in older pediatric and adult patients.FDA Priority ReviewRead More: Reducing Mother-To-Child HIV Transmission To Zero Key To End AIDS In India: ExpertsIn June, the FDA accepted a supplemental new drug application (sNDA) for Tivicay PD that would extend its use to newborns from birth. The agency granted the application Priority Review with a PDUFA action date of August 25, 2026."Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," said Jean van Wyk, chief medical officer at ViiV Healthcare, at the time.Who Should Avoid Tivicay or Tivicay PD?Patients should not receive Tivicay or Tivicay PD if they have had previous allergic reactions to the drug or if they are also receiving dofetilide.Serious allergic reactions have been reported. Patients should be monitored for liver damage. Immune reconstitution syndrome has also been reported in patients treated with combination antiretroviral therapy.Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects. Patients or their caregivers should tell their healthcare provider about all medications they are taking before starting Tivicay or Tivicay PD.Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.What Is HIV?HIV (human immunodeficiency virus) attacks the body's immune system, increasing the chances of developing serious infections or cancer. Without treatment, HIV can lead to AIDS (acquired immunodeficiency syndrome).There is no cure for HIV, but prevention and treatment options are available.Preventing Mother-to-Child HIV TransmissionPediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. The latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life. Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals, according to UNAIDS.An HIV-positive mother can pass the virus to her baby during pregnancy, labor, delivery, or breastfeeding, but proper medical care lowers this risk to less than 1%.

tivicay: us fda approves drug to treat hiv in newborns

About Us

Contact Us

Terms & Conditions

Privacy Policy

Company

Health and Me is a premium website with content written and curated to function as a handbook for all Health concerns.

Tivicay: US FDA Approves Drug to Treat HIV In Newborns

Three Deaths In Chinese Gene Therapy Trials Raise Safety Concerns: Experimental Treatments Under Scrutiny

1 In 4 Former NFL Players Had CTE At Death: Effects Of Repeated Head Trauma Does On The Brain

Dolly Parton Dies At 80 After ‘Brief Battle With Cancer’: What We Know So Far?

Health Conditions A-Z

Tivicay: US FDA Approves Drug to Treat HIV In Newborns

Three Deaths In Chinese Gene Therapy Trials Raise Safety Concerns: Experimental Treatments Under Scrutiny

1 In 4 Former NFL Players Had CTE At Death: Effects Of Repeated Head Trauma Does On The Brain