Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

The Paediatric HIV Treatment Initiative welcomes this important step towards closing the treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's (FDA) tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

(lopinavir)  (ritonavir)

"The announcement of tentative FDA approval of the lopinavir/ritonavir oral pellet formulation is an important step forward in increasing access to World Health Organization-recommended antiretroviral treatment for children under three years of age," said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. Special Representative for Global Health Diplomacy. "This supports the goals of key PEPFAR initiatives to improve paediatric HIV/AIDS services, including the Accelerating Children's HIV/AIDS Treatment Initiative and the Global Pediatric ARV Commitment to Action".

Until now, the only available version of this combination treatment was a harsh-tasting syrup that required refrigeration and contained 40% alcohol. Only a quarter of children with HIV are currently on treatment and the lack of child-adapted formulations contributes to this unacceptable situation.

"UNITAID and its partners in the Paediatric HIV Treatment Initiative (PHTI)* also welcome the approval of these oral pellets, which brings us a step nearer to closing the shameful treatment gap for the 3.2 million children living with HIV around the world," said Lelio Marmora, Executive Director of UNITAID which is funding the development of paediatric formulations for HIV.

Importantly, intellectual property issues around access to future LPV/r combinations will be reduced, thanks to a licensing agreement the Medicine Patent Pool (MPP) signed in in December 2014 with AbbVie, the patent holder for LPV/r. "This is a crucial licence for paediatric programmes as it benefits low- and middle-income countries where 99% of children with HIV in the developing world live," said Greg Perry, Executive Director of the MPP.

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

AbbVie's HIV Drug Aluvia (Lopinavir/ritonavir) Seen as Potential Treatment for Coronavirus

In continuation of my update on Lopinavir/Fritonavior

 

More than 80 people have died from the coronavirus in China. The Chinese government is turning to a drug developed by AbbVie for HIV patients as a potential treatment for the outbreak that has reached the shores of the United States.

AbbVie said it was donating more than one million dollars’ worth of Aluvia, a combination of lopinavir and ritonavir as an ad-hoc treatment for pneumonia that is associated with the outbreak. The Chinese government suggested last week that taking two lopinavir/ritonavir pills and inhaling a dose of nebulized alpha-interferon twice a day could benefit these patients, Reuters reported. There are more than 2,000 known cases of the coronavirus in China. The illness has caused parts of China to grind to a halt as health officials seek to contain the spread of the virus.

The decision to use AbbVie’s medicine came after a noted respiratory expert at Peking University First Hospital in Beijing said he was given the HIV drugs to fight the virus after he contracted it following a visit to Wuhan, the capital of Hubei province in central China where the virus is thought to have originated. Wan Guangfa came down with the virus after interacting with coronavirus patients. He told China News Week that the HIV treatments worked for him.

The coronavirus family includes the common cold as well as viruses that cause more serious illnesses, such as SARS that spread from China to more than a dozen countries in 2002-03 and killed about 800 people. Also, the virus is similar to Middle Eastern Respiratory Syndrome (MERS), which developed from camels. The virus infects the lungs, and symptoms start with a fever and cough. It can progress to shortness of breath and breathing difficulties leading to pneumonia.

Aluvia is thought to be a potential treatment for the coronavirus due to its ability to block a protease that the virus needs to replicate within the human body. AbbVie’s drug has previously been tested in patients with SARS and MERS, which are similar viruses, Endpoints reported.

Other drugmakers are also responding. Gilead Sciences is looking at its Ebola virus drug remdesivir, an antiviral, as a potential coronavirus treatment, The Motley Fool reported. Moderna also has a treatment for the virus under investigation. The company received a grant from the Coalition for Epidemic Preparedness Innovations to investigate a treatment for the virus. Inovio also received a grant from CEPI to develop a potential vaccine.

https://en.wikipedia.org/wiki/Lopinavir/ritonavir

AbbVie's HIV Drug Aluvia Seen as Potential Treatment for Coronavirus