All healthcare
measures that we take are to maintain an efficient and constantly active
immunity. We usually look up to our immune system to protect us from the
attacks of pathogens or threats posed by other etiologies. But what happens
when the immune system itself is taken over?
Viruses are microscopic creatures that are the tiniest but
the most notorious disease causing agents. These organisms are not capable of
multiplying on their own. When they cause an infection, they take over the
human cell machinery for their spread. This bars the usual functioning of the
cells. The Human Immunodeficiency Virus (HIV), a retrovirus, infects key cells
of the immune system known as the T-cells. It thus effectively shades itself
from other components of the system. A pronounced depletion of immune cells
weakens the system. The regular infections that aren’t lethal also burden the
patient’s body greatly. The condition is hence referred to as an Acquired
Immunodeficiency Syndrome (AIDS).
Clinical management of HIV-AIDS is faced with unprecedented
challenges owing to the ability of the virus to evade immune responses. The HIV drug market thus received no boost
until recently.
What is all the hype about?
The marketing clearance of Biktarvy, a drug for HIV-AIDS by
the US FDA shook the world. It was introduced by Gilead Sciences Inc a bio-pharmaceutical
company. Market research reports
forecast sales of about one billion dollars for the establishment in the coming
year. They also suggest a rise to five times this amount by 2024.
The company got a much needed boost from this approval after
a failed quarter. HCV medication, the company’s flagship product saw a great
plummet in its sales. A lost competition with one drug was covered up by a win
in another. The company that had forecasted a further slow-down in the sales
now expects to grow at a faster pace. It has an upper hand in the HIV drug
market because this medication is approved for people who have never taken
anti-retroviral drugs and also for people who have been on a similar medication
for only 3 months with no failure in treatment. Its contemporaries are approved
only for people who’ve been taking similar drugs for at least 6 months and have
no adverse effects. Even the subjects of clinical trials showed no treatment-emergent
resistance.
How does Biktarvy work?
Biktarvy is also referred to as the ‘triple-drug’ for HIV.
Until now, people were using multiple pills to keep the viral count low. But
Biktarvy is based on a once-daily single tablet regimen. It is a combination of
an integrase inhibitor, bictegravir, and nucleoside reverse transcriptase
inhibitors emtricitabine and tenofovir alafenamide. For the HIV to enter the
T-cells of the immune system and take charge, integrase and reverse
transcriptase are crucial enzymes. They allow it to replicate in the human
host. The inhibitors prevent the integration of viral genetic material with the
host genome. The infection hence remains under control.
The body’s response to the drug can be measured in terms of
viral load or T-cell counts. A decrease in the former and a stability or
increase of the latter is indicative of a positive result. Biktarvy works with
no food intake regulations and no minimum required counts of the virus.
Is it safe?
Contraindications:
·
The use of Biktarvy during pregnancy has not
been studied sufficiently
·
The drug cannot be used along with medications
containing dofetilide or rifampin.
Adverse reactions:
Diarrhea, nausea, and headaches were commonly observed side
effects during the clinical trials. However, there can be more severe reactions
in the body post intake of Biktarvy. Medical conditions of buildup of lactate
and abnormal functioning of enzymes and transporters in the body have been
reported due to the administration of this drug. These can lead to fatal
medical situations.
Worsening existing impairments:
People with renal or hepatic implairments have been advised
against the usage of this drug. It is known to exacerbate these issues. Instead
of treating AIDS, Biktarvy in very rare cases, also caused fatal autoimmune
disorders.
The future of the drug:
Biktarvy, in its trial phases has shown to be highly
efficient with minimum challenges and threats. It has also helped raise Gilead
back in the field of bio-pharmaceuticals. The FDA approval has paved way for
the long term sustainability of the company. It will continue to compete in the
field of its core franchise.
