An experimental once-daily pill that combines four drugs to fight the human immunodeficiency virus (HIV) is as safe and effective as commonly prescribed treatments against the AIDS virus, researchers reported in the Lancet on Friday.
Doctors tested the new drug, called Quad, for the third and final phase in which new pharmaceutical products are vetted for safety and effectiveness.
Publication in the British journal follows a recommendation in May by a US Food and Drug Administration advisory panel to approve Quad for previously untreated adults infected with HIV-1. A final decision is expected by next month.
The first trial entailed testing Quad against a three-in-one pill, Atripla, which since 2006 has been a standard treatment for HIV.
Researchers enrolled 700 patients in centers in North America and assigned them randomly to either Quad or Atripla.
After 48 weeks of treatment, 88 percent of Quad patients had suppressed viral loads to below detectable levels, against 84 percent in the Atripla group.
Side effects were infrequent, but similar in both groups. Among Quad patients, mild nausea was the more common adverse event, whereas with Atripla, symptoms were likelier to be dizziness, abnormal dreams or insomnia and skin rashes.
In the second trial, 708 patients were enrolled in Australia, Europe, North America and Europe.
Patients were either given Quad or a widely recommended therapy comprising the molecules atazanavir (ATV), boosted by ritonavir (RTV), together with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).
After 48 weeks, 90 percent of the Quad group had viral levels below detectable levels compared with 87 percent in the other drug group.
Only 3.7 percent of patients in the Quad group stopped treatment because of side effects, compared with 5.1 percent in the other group. On the other hand, the number who reported kidney complications in the Quad group was higher.
Quad comprises FTC and TDF, along with a drug called elvitegravir (ETV), which is designed to inhibit HIV replication. The fourth ingredient is a “pharmacoenhancer” called cobicistat which is used to boost the effectiveness of ETV.
The movement toward a single once-daily pill to suppress HIV has a huge benefit for patients, AIDS researchers said.
When the first antiretroviral drugs emerged in the 1990s, patients had to take a dozen tablets or more a day, a “pill burden” that meant many forgot to follow the entire treatment.
“Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant,” said Paul Sax of Harvard Medical School, who led the first study in the Lancet on Friday.
Quad is made by the US pharmaceutical giant Gilead Sciences, which also funded the trials, a practice that is relatively common in drug development.
Clinical tests for new drugs have to go through a three-phase process that is scrutinized by independent assessors and government regulators for safety and objectivity. Publication of the research in a peer-reviewed journal is the final step in the procedure.
In the sweltering streets of Jakarta, buskers carry towering, hollow puppets and pass around a bucket for donations. Now, they fear becoming outlaws. City authorities said they would crack down on use of the sacred ondel-ondel puppets, which can stand as tall as a truck, and they are drafting legislation to remove what they view as a street nuisance. Performances featuring the puppets — originally used by Jakarta’s Betawi people to ward off evil spirits — would be allowed only at set events. The ban could leave many ondel-ondel buskers in Jakarta jobless. “I am confused and anxious. I fear getting raided or even
Eleven people, including a former minister, were arrested in Serbia on Friday over a train station disaster in which 16 people died. The concrete canopy of the newly renovated station in the northern city of Novi Sad collapsed on Nov. 1, 2024 in a disaster widely blamed on corruption and poor oversight. It sparked a wave of student-led protests and led to the resignation of then-Serbian prime minister Milos Vucevic and the fall of his government. The public prosecutor’s office in Novi Sad opened an investigation into the accident and deaths. In February, the public prosecutor’s office for organized crime opened another probe into
RISING RACISM: A Japanese group called on China to assure safety in the country, while the Chinese embassy in Tokyo urged action against a ‘surge in xenophobia’ A Japanese woman living in China was attacked and injured by a man in a subway station in Suzhou, China, Japanese media said, hours after two Chinese men were seriously injured in violence in Tokyo. The attacks on Thursday raised concern about xenophobic sentiment in China and Japan that have been blamed for assaults in both countries. It was the third attack involving Japanese living in China since last year. In the two previous cases in China, Chinese authorities have insisted they were isolated incidents. Japanese broadcaster NHK did not identify the woman injured in Suzhou by name, but, citing the Japanese
RESTRUCTURE: Myanmar’s military has ended emergency rule and announced plans for elections in December, but critics said the move aims to entrench junta control Myanmar’s military government announced on Thursday that it was ending the state of emergency declared after it seized power in 2021 and would restructure administrative bodies to prepare for the new election at the end of the year. However, the polls planned for an unspecified date in December face serious obstacles, including a civil war raging over most of the country and pledges by opponents of the military rule to derail the election because they believe it can be neither free nor fair. Under the restructuring, Myanmar’s junta chief Min Aung Hlaing is giving up two posts, but would stay at the
RSS