A research study from
Infectious Disease Society of America on Ibalizumab drug shows new hope in
treating multi-drug resistant (MDR) HIV patients.
‘Ibalizumab drug administered intravenously once every two weeks will be beneficial in treating Multi-drug resistant 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
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
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
. 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
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.
of the patients showed a decrease in viral load of 0.5 log10.
average decrease in viral load of 1.1 log10 was noted after seven days of
- 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."
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
Side effects reported to
Ibalizumab drug include:
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
- 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.
pregnant women are recommended to take HIV medicines for preventing mother
to child transmission.
Fact Sheet 2016 - (http://www.unaids.org/en/resources/fact-sheet)
- AIDS Global Statistics - (https:www.aids.gov/hiv-aids-basics/hiv-aids-101/global-statistics/)
in India - (http://www.avert.org/professionals/hiv-around-world/asia-pacific/india)
- Ibalizumab - Drug
Information - (https:aidsinfo.nih.gov/drugs/511/ibalizumab/0/patient)