New Long-Acting HIV Drug Approved by FDA

Individuals suffering from human immunodeficiency virus (HIV) may have the availability of a new long-acting drug approved by the U.S. Food and Drug Administration (FDA).

Key takeaways:
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    FDA approves new long-acting treatment to fight HIV, the first of its type to fight the virus.
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    HIV patients struggling to benefit from current treatments could require the newly-announced drug called Sunlenca.
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    HIV is still a major problem in the U.S., with 1,189,700 Americans diagnosed by the conclusion of 2019.

On Thursday the FDA approved Gilead Sciences Inc's Sunlenca (lenacapvir). The new drug is supposed to be more efficient than current methods for the virus, with treatments occurring only twice per year in combination with other antiretrovirals (ARV) medication.

Gilead Sciences points to Sunleca as a breakthrough due to its long-acting potential. During the most recent trial, Sunlenca was able to sustain a high rate of virologic suppression. The drug is consumed through both tablets and injections.

Sorana Segal-Maurer M.D. is the Director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at New York-Presbyterian Queens and a Professor of Clinical Medicine at Weill Cornell Medicine. She was also the Site Principal Investigator for the most recent lenacapavir trial prior to approval.

"The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multi-drug resistant HIV,” Segal-Mauer said. “Following today’s decision from the FDA, lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices,"

Sorana Segal-Maurer M.D.

Lenacapavir was approved through the FDA Breakthrough Therapy Designation, a process that advances reviews of new drugs proving to be effective versus normal therapy. In the trials, 83% of participants receiving the lenacapavir along with other drugs contained an undetectable viral load.

Currently, lenacapavir is not available for treatment by itself in the U.S., United Kingdom, Canada, or other countries within the European Union. Gilead Sciences notes that the study is purely for proving lenacapavir’s ability to prevent HIV, not the safety or efficiency of the drug.

Chairman and Chief Executive Officer of Gilead Sciences, Daniel O’Day, believes Sunlenca is just one of many possible HIV treatments on the way from the drug company.

“Gilead scientists have developed a unique and potent antiretroviral medicine in Sunlenca with the potential for flexible dosing options,” O’Day said. “Our goal is to deliver multiple long-acting options for treatment and prevention that are tailored to the needs of people living with HIV.”

Sunlenca does feature some side effects due to injection site reactions, including swelling, pain, erythema, nodule, induration, pruritus, extravasation, or mass. After an average 553-day follow-up period, 30% of nodules and 13% of indurations remained in patients experiencing these side effects. Also, patients consuming Sunlenca along with antiretroviral therapy experienced inflammatory responses during the trial’s initial phase.

HIV cases in the U.S. are decreasing

In 2020, 30,635 Americans were diagnosed with HIV. Overall, the number of new HIV diagnoses has decreased by 8% from 2016 to 2019. Based on those 2020 statistics from the Centers For Disease Control (CDC), males engaging in sexual contact with other males accounted for 68% of new diagnoses, versus 22% for heterosexual contact.

However, your sexuality does not keep you at risk of HIV if proper precautions are not taken during sex. The CDC recommends proper condom usage to prevent HIV and other sexually transmitted diseases. Intercourse is not the only cause of HIV, as 1 in 10 HIV cases is due to contaminated injection drug use.

Only a test can confirm HIV, but there are symptoms that do onset when ill with the virus. Flu-like symptoms occur two to four weeks after infection and vary from a few days to weeks. They include a fever, sore throat, night sweats, chills, fatigue, muscle aches, swollen lymph nodes, and mouth ulcers.

The three stages of HIV:

  • Acute HIV infection: Beginning stage of HIV, individuals must seek a test due to large amounts of HIV in the blood that can be very contagious.
  • Chronic HIV Infection: Patients may not display symptoms, but can still transmit HIV during this phase. If treated, HIV patients may never make it to stage 3. If not treated, stage 2 can last up to 10 years or more before advancing to stage 3.
  • Acquired Immunodeficiency Syndrome (AIDS): The most severe stage of HIV, with patients able to easily transmit the virus to others. Other illness may arise during AIDS, and those who don’t receive treatment live no longer than three years with the disease.

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