Ibalizumab Drug - First Monoclonal Antibody for Multi-Drug Resistant HIV Treatment

A research study from Infectious Disease Society of America on Ibalizumab drug shows new hope in treating multi-drug resistant (MDR) HIV patients.

The Phase 3 clinical trial study on the first monoclonal antibody for HIV was presented at the IDWeek 2016 meeting.

Human immuno deficiency virus (HIV) mainly attacks the immune system and results in a number of infections. HIV infections when left untreated may advance to AIDS ( Acquired Immuno Deficiency Syndrome).

According to the UNAIDS, around 36.7 million people in the world live with HIV/AIDS and 2.1 million people are newly infected with the disease by the end of 2015.

In India, 2.1 million people are living with HIV and 86,000 people are found to be newly affected with the infection.

Research Study on Ibalizumab Drug for MDR Resistant HIV

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The study was conducted on 40 MDR HIV patients who were treated with HIV medicines in the past 21 years. 28% of the patients were found to take 10 or more HIV medications. All of them were given ibalizumab drug, out of which 35% of the patients required an additional investigational medicine due to the resistance developed to HIV medications.

The benefits of the new drug were evaluated in terms of the patient’s viral load after seven days of treatment.

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Viral load is a measure of number of virus particles present in one milliliter of blood.

• 60% of the patients were found to show a marked decrease in the viral load of 1.0 log10 or greater.
• 83% of the patients showed a decrease in viral load of 0.5 log10.
• An average decrease in viral load of 1.1 log10 was noted after seven days of treatment.
• Only 3% of the patients in the control period (before taking ibalizumab drug) were found to have a decrease in the viral load after taking existing HIV medications.

After seven days, all the patients were prescribed with ibalizumab drug by optimizing their existing HIV medications for treatment.

Ibalizumab Drug - First HIV Monoclonal Antibody

Ibalizumab is a new monoclonal antibody for Multi-Drug Resistant HIV patients. It is a genetically engineered molecule which gets coated with the cells of the immune system to protect it from the entry of HIV.

Ibalizumab drug is administered intravenously into the vein, once every two weeks.

Jacob Lalezari, MD, lead author of the study and medical director for Quest Research, a division of eStudySite, San Franscisco said,"This is the first drug in a long time for patients with multidrug resistance."

"This therapy showed good activity in patients who were resistant to everything else, which is very exciting for these vulnerable patients and those who care for them." he added.

Daniel R. Kuritzkes, MD, chief of the Division of Infectious Diseases at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, Boston said that "This drug benefits a small but challenging population of HIV patients who are highly treatment experienced."

"This will not be a first- or second-line therapy for those who are infected with HIV, but it may be helpful for certain patients." he added.

Dr. Lalezari said that "There's higher compliance because they have a place where they can go and are cared for, and it really works for them," and biweekly regimen of Ibalizumab drug would be beneficial to the patients.

Side Effects of Ibalizumab:

Side effects reported to Ibalizumab drug include:

• Headache
• Skin Rash
• Diarrhea
• Nausea

These common side effects of the drug were reported during the Phase 2 clinical trial of the study and are normally considered to be mild or moderate.

Facts on HIV

• 25.6 million people affected with HIV are from Sub -Saharan Africa.
• HIV infections are diagnosed by detecting the presence or absence of HIV antibodies (Enzyme immunoassays).
• HIV infections have no cure and anti-retroviral drug therapy can only control the replication or prevent the transmission of the virus.
• HIV infections cannot be transmitted by kissing, shaking hands, or sharing food or water.
• HIV pregnant women are recommended to take HIV medicines for preventing mother to child transmission.

References:

1. UN/AIDS Fact Sheet 2016 - (http://www.unaids.org/en/resources/fact-sheet)
2. AIDS Global Statistics - (https://www.aids.gov/hiv-aids-basics/hiv-aids-101/global-statistics/)
3. HIV/AIDS in India - (http://www.avert.org/professionals/hiv-around-world/asia-pacific/india)
4. HIV/AIDS - (http://www.who.int/mediacentre/factsheets/fs360/en/)
5. Ibalizumab - Drug Information - (https://aidsinfo.nih.gov/drugs/511/ibalizumab/0/patient)

Source-Medindia