HPTN Studies Inform FDA’s Approval of ViiV Healthcare’s Long-Acting Cabotegravir Injections for HIV Prevention

DURHAM, N.C., Dec. 21, 2021 (GLOBE NEWSWIRE) — Data from the HIV Prevention Trials Network (HPTN) studies HPTN 083 and HPTN 084 helped provide important information for yesterday’s decision by the U.S. Food and Drug Administration (FDA) to approve ViiV Healthcare’s long-acting cabotegravir (CAB-LA) injections for the prevention of HIV. Sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), these studies showed that CAB-LA injected once every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis (PrEP) option for individuals at risk for HIV infection. ViiV Healthcare will market CAB-LA for PrEP under the brand name Apretude.

“This is a truly critical milestone for HIV pre-exposure prophylaxis providing a safe and effective alternative to daily pills,” said Dr. Myron Cohen, HPTN co-principal investigator, and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “Until we have a cure or vaccine, more prevention options that meet the needs of individuals at risk for HIV around the world are essential.”

HPTN 083 was co-funded by NIAID and ViiV Healthcare. HPTN 084 was co-funded by NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study product was provided by ViiV Healthcare and Gilead Sciences, Inc. Three other NIH institutes also collaborated on HPTN 083 and HPTN 084: the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

HPTN 083 enrolled 4,570 cisgender men and transgender women who have sex with men at research sites in Argentina, Brazil, Peru, South Africa, Thailand, the U.S., and Vietnam. In the study, 52 HIV infections occurred, with 12 new infections in the CAB arm and 39 new infections in the TDF/FTC arm. These findings translate to a 69 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.

HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. There were three new infections in the CAB arm and 36 new infections in the TDF/FTC arm, a 92 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.

“HIV continues to disproportionately impact specific populations who need new HIV prevention options that are not only convenient but also highly effective,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York. “CAB-LA is a long-awaited and welcomed addition to the HIV prevention toolkit, offering a potentially convenient option for so many around the world.”

About the HPTN

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members, and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.

Media inquiries: Eric Miller, +1.919.384.6465; emiller@fhi360.org

CUAMBA SOLAR PV et ENERGY STORAGE ONT ATTEINT LA CLÔTURE FINANCIÈRE

MAPUTO, Mozambique, 21 décembre 2021 /PRNewswire/ — Globeleq, la principale société indépendante d’électricité en Afrique, et ses partenaires de projet, Source Energia, un développeur d’énergie en Afrique lusophone, et Electricidade de Moçambique (EDM), la société nationale d’électricité du Mozambique, ont atteint la clôture financière de la centrale solaire photovoltaïque de 19 MWp (15 MWac) de Cuamba avec un système de stockage d’énergie de 2 MW (7 MWh).

Globeleq - Powering Africa's Growth

Le projet de 36 millions de dollars, situé dans le district de Cuamba, dans la province de Niassa (à environ 550 km à l’ouest de la ville côtière de Nacala), fournira de l’électricité dans le cadre d’un contrat d’achat d’électricité de 25 ans conclu avec EDM. Le projet est le premier IPP au Mozambique à intégrer un système de stockage d’énergie à l’échelle des services publics et comprend une mise à niveau de la sous-station existante de Cuamba.

Une fois opérationnelle, la centrale solaire de Cuamba fournira suffisamment d’électricité pour 21 800 consommateurs et, pendant toute la durée du projet, elle devrait permettre d’éviter l’émission de plus de 172 000 tonnes de CO2. La centrale devrait commencer à produire de l’électricité au cours du deuxième semestre de 2022.

L’Emerging Africa Infrastructure Fund (« EAIF »), société membre du Private Infrastructure Development Group (« PIDG »), a fourni 19 millions de dollars de financement par emprunt, tandis que le mécanisme de subvention Viability Gap Funding (VGF) du PIDG a fourni 7 millions de dollars pour garantir un tarif abordable, financer les améliorations essentielles du réseau et un système de stockage d’énergie pour EDM. CDC Plus, le mécanisme d’assistance technique du groupe CDC, a apporté une subvention de 1 million de dollars pour le système de stockage d’énergie par batterie.

Olivia Carballo, une directrice de Ninety One Ltd, les gestionnaires de l’EAIF, a commenté : « C’est un projet pionnier pour l’EAIF et le PIDG. Nous félicitons Globeleq, Source Energia, EDM et le Mozambique d’avoir atteint une étape clé dans le déploiement de plus de technologie solaire sur le réseau du nord, et d’avoir installé le premier système de stockage d’énergie par batterie à l’échelle du réseau du Mozambique. »

Sarah Marchand, directrice de CDC Plus, a déclaré : « Nous sommes ravis de soutenir l’un des premiers systèmes de stockage d’énergie par batterie à l’échelle du réseau en Afrique subsaharienne, grâce à cette subvention pour le système de stockage par batterie. En accord avec l’ambition de CDC de catalyser davantage de solutions de stockage sur le continent, CDC Plus offrira également un soutien pour acquérir et diffuser les apprentissages concernant l’impact opérationnel, économique et de développement du composant batterie.

« Face aux difficultés persistantes dues à la pandémie, je me félicite du fait que notre équipe ait atteint la clôture financière, et que nous puissions commencer à construire la première installation solaire et de stockage d’énergie du pays. Nous soutenons sans réserve le gouvernement mozambicain dans ses initiatives visant à soutenir l’Accord de Paris et à fournir à ses citoyens des options d’énergie alternative fiables et propres », a ajouté Mike Scholey, PDG de Globeleq.

Marcelino Gildo Alberto, président d’EDM, a affirmé : « Ce projet est une démonstration de l’engagement d’EDM à fournir des solutions durables pour accélérer l’accès de la population mozambicaine à l’énergie. Conformément au plan quinquennal du gouvernement visant à introduire 200MW d’énergie renouvelable, EDM est à l’avant-garde de la transition énergétique en accord avec l’Accord de Paris. »

« Nous sommes très heureux d’apporter une nouvelle contribution au secteur de l’énergie au Mozambique et nous sommes impatients de soutenir la croissance future de l’industrie dans le pays. Nous remercions nos partenaires de projet et nos bailleurs de fonds pour leur patience et leur engagement inégalés pendant la phase de développement », a déclaré Pedro Coutinho, PDG de Source Energia

Le projet nécessitera environ 100 travailleurs pendant la phase de construction, dont beaucoup seront recrutés au sein de la communauté locale. La société espagnole Grupo TSK a été désignée comme entrepreneur EPC du projet et va immédiatement commencer à mobiliser son équipe de construction. E22, qui fait partie du groupe espagnol Gransolar, fournira le système complet de stockage d’énergie par batterie. Globeleq supervisera la construction et l’exploitation de la centrale, avec le soutien de Source Energia.

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Apple Must Answer Shareholder Questions on Forced Labor, SEC Says

The U.S. Securities and Exchange Commission has declined an effort by Apple Inc. to skip a shareholder proposal asking the iPhone maker to provide greater transparency in its efforts to keep forced labor out of its supply chain.

A group of shareholders earlier this year asked Apple’s board to prepare a report on how the company protects workers in its supply chain from forced labor. The request for information covered the extent to which Apple has identified suppliers and sub-suppliers that are a risk for forced labor, and how many suppliers Apple has taken action against.

In a letter from the SEC reviewed by Reuters on Wednesday, regulators denied Apple’s move to block the proposal, saying that “it does not appear that the essential objectives of the proposal have been implemented” so far.

The letter means that Apple will have to face a vote on the proposal at its annual shareholder meeting next year, barring a deal with the shareholders who made it.

Apple did not immediately respond to a request for comment.

American lawmakers last week passed a bill banning imports from China’s Xinjiang region over concerns about forced labor.

“There’s rightfully growing concern at all levels of government about the concentration camplike conditions for Uyghurs and other Turkic Muslims living under Chinese government rule,” Vicky Wyatt, campaign director for SumOfUs, a group supporting the shareholder proposal, said in a statement on Wednesday.

Apple routinely asks the SEC to skip shareholder proposals, and the requests are granted about half the time.

The SEC also denied Apple’s request to skip a shareholder proposal that would give investors more information about the company’s use of nondisclosure agreements.

Source: Voice of America

Australian Research Identifies Kidney-Protecting Gene

Researchers in Australia have identified a gene that indicates the kidney has its own way of resisting damage. However, they have also identified a mutation of the gene that can in patients with, for example, diabetes, trigger the development of renal disease.

A gene called VANGL1 has been found to help stop the immune system from attacking the kidney. But Australian researchers say the genetic mutation, which is present in about 15% of the population worldwide, can cause renal disease in patients with diabetes and other autoimmune conditions.

The mutation is highly prevalent among indigenous people on the Tiwi Islands, 80 kilometers from the city of Darwin in the Northern Territory. According to the study, just less than 50% of the islands’ residents have the genetic mutation.

The islands’ recorded rates of kidney disease are four times those of mainland indigenous Australians and about 11 times that of non-Indigenous Australians, according to researchers.

Dr. Simon Jiang is from the John Curtin School of Medical Research at Australian National University. He says the mutation is mostly benign in healthy adults.

“If your body is not inflamed and you are otherwise healthy, it is probably not too much of an issue. It is when you have another condition that occurs on top of it. And so in the Tiwi Islands, rates of infection, of diabetes and probably some immune diseases, are a lot higher than the rest of Australia. And so, when you have that process happening within your body, what is initially a reasonably benign mutation suddenly takes on a new turn and becomes something that is really bad news for the kidney,” Jiang said.

The study could lead to better transplant screening that would identify potential donors who have the genetic mutation.

The study was published Wednesday in the journal Cell Reports Medicine.

Source: Voice of America

Madagascar’s Police Minister and Fellow Crew Member Survive 12 Hours in Indian Ocean Following Helicopter Crash

Madagascar’s police minister and an air force mechanic are safe after being stranded in the ocean for 12 hours following a helicopter crash in the Indian Ocean.

Gen. Serge Gellé, 57, the Secretary of State for the Gendarmerie, was plucked from the water by fishermen, while Chief Warrant Officer Jimmy Laitsara managed to swim to shore.

The two were among four passengers on the helicopter, which was surveying the scene of a shipwreck Monday that left at least 64 dead. The other two are still missing.

“My turn to die has not yet come, thank God. I’m well. I’m just cold,” said Gelle, who looked exhausted, in a video posted on Twitter. “But I’m sad because I don’t know if my friends are alive.”

He said he did not have a life jacket and used his seat as a floatation device.

The cause of the crash is still under investigation.

The shipwrecked boat, the Francia, is believed to have sunk due to flooding in the engine room. Twenty passengers are still missing.

Source: Voice of America

Madagascar shipwreck death toll rises to 64

The death toll from a shipwreck off Madagascar’s northeastern coast has risen to at least 64 after 25 more bodies were discovered, maritime authorities said Wednesday.

A wooden vessel, believed to be a cargo ship carrying passengers illegally, sank in the Indian Ocean on Monday with 130 people on board.

Forty-five passengers were rescued and around 20 remain missing. The search for survivors continues.

“Twenty-five bodies were found this morning near Sainte-Marie islands, probably due to sea currents, which brings the death total to 64,” gendarmerie general Zafisambatra Ravoavy told AFP.

Maritime authorities said initial investigations suggested the vessel’s engine had a “technical problem”, leaving the boat vulnerable to tidal forces and causing it to run aground on a reef.

A Malagasy government minister who travelled to the disaster scene swam 12 hours to shore on Tuesday after his helicopter crashed off the island nation’s northeastern coast.

Source: Seychelles News Agency