Tag: antiretroviral medications

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Once-A-Month Injection Approved For HIV

The FDA has approved Cabenuva, a once-a-month injection to control HIV infection
(image via Depositphotos)

The U.S. Food and Drug Administration has approved a long-acting once a month injection that can replace the daily pills now used to control HIV infection.

This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.

Medical researchers expect the two-shot combo called Cabenuva will make it easier for HIV+ people to stay on schedule with their HIV medications.

Cabenuva consists of two drugs packaged together – rilpivirine and cabotegravir – but given as separate shots once a month. Cabenuva is administered as two intramuscular injections in the buttocks by a healthcare professional.

The drug makers are also testing the effectiveness of taking the injection every 8 weeks. The FDA approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not exhibited signs of viral resistance to the two drugs in Cabenuva. The FDA also approved Vocabria (a tablet form of cabotegravir), which should be taken in combination with oral rilpivirine for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

Dr. Steven Deeks, an HIV specialist at the University of California, told ABC News that a once-a-month treatment “will enhance quality of life” for those on HIV medications. “People don’t want those daily reminders that they’re HIV infected.”

Deeks also believes a monthly dose may be easier for some who have a difficult time staying on a daily schedule like those with mental illness or substance abuse issues.

In addition to treating those living with HIV, ViiV Healthcare (the maker of cabotegravir) hopes to make their drug available as PrEP for HIV prevention.

Two studies have shown an injection of cabotegravir every two months was more effective than taking Truvada on a daily basis.

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Study Shows First HIV Patient ‘Cured’ Using Only Medications

For the first time, an HIV-positive patient has gone into long-term remission after being treated with a multi-drug cocktail raising hopes of a possible cure on the horizon. The patient, a 34-year-old Brazilian man diagnosed in 2012, was put on a three-drug regimen of antiretroviral therapy (ART) which was intensified with additional antiretrovirals plus  a skin cancer preventative called Nicotinamide, a water-soluble version of vitamin B3. Dr. Andrea Savarino, of the Instituto Superiore di Sanitá in Rome, Italy, explained the approach in a presentation to the UK organization AIDSmap prior to the 2020 International AIDS conference in San Francisco. The intensified treatment was stopped after 48 weeks and he returned to his normal three-drug regimen. In March 2019, he began a medically-supervised treatment interruption, stopping his antiretroviral therapy. His last tests (taken on June 22, 2020) show his viral load has remained undetectable, meaning he has maintained viral suppression for more than 65 weeks without antiretroviral medications. The patient’s HIV antibody tests also came back negative. “The virus did not rebound, the viral DNA was maintained negative,” Savarino said. “The antibody response decreased over time, if the antibody decreases, it is possible that the virus has stopped its repetition.”

(illustration of HIV cells)
While exciting news, Savarino cautions “the result is highly likely not to be reproducible,” describing these results as “preliminary.” He noted that four other patients were given the same regimen but HIV was not found to have been put in check in those individuals. The Brazilian patient is still being monitored to see if HIV has truly been eradicated from his system. Since the early 1980s, scientists have worked diligently to find a cure for HIV, which has infected more than 75 million people and killed almost 33 million since the AIDS epidemic began. Modern medications available today allow patients to control the virus and keep HIV in check, but Reuters reports there are an estimated 38 million people are currently living with HIV. There have been three prior reports of individuals apparently being ‘functionally cured’ (long-term remission) of HIV, but those cases were the result of complicated, invasive bone marrow transplants. All three received transplants from donors with a mutated gene for the CCR5 protein found on white blood cells. While HIV relies on the protein to enter the cells, the mutated version apparently blocks the virus from attaching to those cells. (source: Reuters, AIDSmap)

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News Round-Up: July 2, 2020

Some news items you might have missed: • Instagram: If you don’t already, click over and follow @BigKidProblems (above) on the Gram of Insta….I like the way they think 🙂 • Christian Post: A professional photographer has filed a lawsuit against a new Virginia law that he says would force him to violate his sincerely held Christian beliefs by requiring him to provide his services to same-sex weddings. • NBC News: The Trump administration is moving to repeal transgender protections in homeless shelters. If the proposal is implemented, transgender women could be placed in sex-segregated shelters for men. • NY Times: U.S. payrolls grew by 4.8 million in June, according to the Labor Department. It was the second month of gains after a loss of more than 20 million in April when the pandemic put a large swath of economic activity on ice. The unemployment rate fell to 11.1 percent, down from a peak of 14.7 percent in April but still higher than in any previous period since World War II.

(image via NY Times)
• American Journal of Managed Care: A new study of nearly 78,000 HIV+ people diagnosed with coronavirus indicates that antiretroviral therapy (ART) medications may reduce a person’s risk of getting coronavirus and/or reduce the severity of the disease should they contract it. • Hollywood Reporter: Hugh Downs, the congenial broadcaster whose thousands of hours on network television included two decades on the ABC’s  20/20 and 9 years as the host of NBC’s Today Show, has died. He was 99. Downs also hosted the game show Concentration for nearly a decade as well as five years as announcer and side-kick to Jack Paar on The Tonight Show. • Reuters: Democrat Joe Biden edged out Republican Donald Trump in fundraising for a second straight month in June, according to reports from the rival U.S. presidential campaigns. Biden and allied Democratic groups raked in over $141 million during the month, while Donald Trump and closely tied groups hauled $131 million. • Karen Chronicles: A Costco customer refused to wear a face mask while returning an item. So she staged a sit-in. For perspective, the second video shows you how a Black man was treated when he refused to wear a face mask. Please note the difference in how the two were treated.

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Merck Gets FDA Approval On 2 New HIV Meds

Pharmaceutical drug giant Merck has obtained approval from the Food and Drug Administration (FDA) for two new medications to address HIV.

Pifeltro (doravirine) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI). That medication is paired in a three-drug single tablet dose to be marketed as Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).

Both are indicated for treating HIV-1 in adults with no prior anti-retroviral treatment.

The approval for the once-a-day pills come after two double-blind, active-controlled phase 3 trials showed positive results.

In a trial called “Drive-Ahead,” 728 patients were treated with either Delstrigo or Gilead’s Atripla for 48 weeks.

At the end of the study, viral suppression rates were similar with Delstrigo reaching 84% and Atripla achieving 81% suppression.

In addition to edging Atripla on viral suppression, Delstrigo patients saw better results regarding LDL cholesterol and non-HDL cholesterol.

The Delstrigo group also experienced lower incidence of neuropsychiatric adverse issues like sleep problems, dizziness and being able to concentrate more clearly.

While there is currently no cure for HIV/AIDS, the Centers for Disease Control have previously announced that when HIV+ folks stay on their prescribed medications on a daily basis, not only are viral loads lowered to ‘undetectable,’ but ‘undetectable’ means the virus is untransmittable.

(h/t PharmaPhorum)

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New Study: Gay Men On Anti-Retroviral Meds Have “Pretty Much” Zero Chance Of Infecting Others

Results of a new large-scale study of gay men presented this week at the 9th International AIDS Conference on HIV Science in Paris shows HIV+ people taking regular antiretroviral medication have “pretty much” a zero chance of infecting others during either gay or straight sex.

From the Washington Blade:

In the largest-ever trial on HIV transmission risk among gay men, Australian researchers explored the sex lives and HIV rates of more than 350 homosexual couples where one person is HIV positive. The couples were from Brazil, Thailand and Australia, CNN reports.

Each couple reported their sexual activity when visiting clinics involved in the trial and HIV-negative partners were regularly tested to diagnose any new infections, CNN reports. The couples participating reported having sex almost 17,000 times without condoms between them over four years, and none of those times resulted in new infections.

”There was not a single linked HIV infection in these couples,” said Andrew Grulich, professor of epidemiology at the University of New South Wales in Australia, who led the study. “Nobody became infected from their partner,” CNN quoted him as having said.