Search Results for “HIV” – media

New Lab Test Detects Persistent HIV Strains in Africa

Most research on the human immunodeficiency virus (HIV) has concentrated on the virus variants prevalent in Western nations, primarily impacting men who have sex with men, with a focus on subtype B. However, less attention has been given to the variants in Africa, where the virus significantly affects women. To develop a universally effective cure, it’s crucial to investigate viral variants not only in developed regions but across different global demographics. Researchers have now developed a test to measure HIV persistence in individuals predominantly affected by African viral strains—a critical step towards finding a cure that can aid patients globally. This research, published in Nature Communications on July 2, addresses a significant shortfall in HIV research. The findings of the study by a multinational team led by investigators at Weill Cornell Medicine (New York, NY, USA)—similar to findings in the developed world—revealed that African HIV strains form viral reservoirs in ...
- Source: drugdu
- 107
- July 5, 2024
Level Up Your Self Love, Check Your Status

Don Tracy, Associate Editor As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness. Today is National HIV Testing Day (NHTD) and as part of this year’s theme, “Level up your self-love: check your status,” individuals across the United States are being encouraged to get tested to show value, respect, and compassion for each other by taking charge of our health and wellness, according to the Centers for Disease and Control Prevention (CDC). “HIV testing is an essential entry point for services such as PrEP for those without HIV, and HIV treatment for those who have HIV,” reports the CDC. “Testing programs have been critical contributors to the 12% decrease in estimated HIV infections from 2018 to 2022, and a major factor contributing to ongoing disparities in HIV is a lack of ...
- Source: drugdu
- 93
- June 29, 2024
Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

On May 13, 2024, GlaxoSmithKline (“GSK”) announced that ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration (“SDA”) for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China (“SDA”) for HIV-1 pre-exposure prophylaxis (“PrEP”) in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections (“STIs”) in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release. Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. ...
- Source: drugdu
- 121
- May 15, 2024
Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower ...
- Source: drugdu
- 80
- May 5, 2024
Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually A trial led by researchers at Queen Mary University London, in partnership with two research institutes in Zambia and Zimbabwe, has identified the mechanisms that contribute to the long-term impacts of severe acute malnutrition (SAM) and HIV infection in children. Funded through the Medical Research Council’s (MRC) Global Challenges Research Fund, the study published in Nature Communications aims to identify a treatment to promote the healing of intestinal damage caused by SAM. Affecting around 17 million children every year, predominantly in Africa, SAM and malnutrition are responsible for almost half of all child deaths globally and cause damage to the enteropathy, the small intestine, by reducing its ability to absorb nutrients. The new phase 2 trial, involving 125 children who had been hospitalised due to complications from arising SAM, evaluated four ...
- Source: drugdu
- 119
- April 25, 2024
FDA Approves Johnson & Johnson’s Edurant PED for Pediatric Patients With HIV

Davy James Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg. The FDA has approved an expanded indication for Johnson & Johnson’s Edurant PED (rilpivirine) in combination with other antiretroviral therapies (ART) to treat HIV-1 in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) aged at least 2 years and weighing between 14 kg and 25 kg.1 Edurant is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor previously approved in combination with ART in treatment-naïve patients 12 years of age and older who weigh at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. “Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their ...
- Source: drugdu
- 148
- March 23, 2024
Further HIV progress needed among heterosexual women

More awareness is needed to encourage women to take up HIV testing amid slow progress in tackling transmission, the UK Health Security Agency’s Chief Medical Adviser has warned today. Despite a significant fall in cases among gay and bisexual men between 2019 and 2022, heterosexual groups are not following the same trajectory. Since 2021, progress has slowed in reducing HIV transmission among heterosexual women, with cases rising by 26% from 447 to 564 in 2022. And in 2022, 40% of women attending sexual health services were not offered an HIV test compared to 27% of heterosexual men and 23% of gay and bisexual men who weren’t offered a test. Factors including a fall in the number of heterosexuals testing since the COVID-19 pandemic and a focus on groups other than women are among the reasons believed responsible. Women were also less likely to start or continue PrEP, according to the ...
- Source: drugdu
- 74
- March 12, 2024
ViiV Healthcare Reveals Positive Results from Phase I Trial for a Potential Longer-Acting HIV Treatment

Don Tracy, Associate Editor Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.Image Credit: Adobe Stock Images/alexskopjeViiV Healthcare has announced promising results from a Phase I study on a new formulation of cabotegravir (Apretude), known as cabotegravir ultra long-acting (CAB-ULA) for HIV pre-exposure prophylaxis (PrEP). Findings suggested that CAB-ULA is well-tolerated and has a pharmacokinetic profile supportive of extended dosing intervals. According to a company press release, the formulation allows dosing intervals of four months, resulting in a reduction of clinical visits for HIV patients.1 “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said Kimberly Smith, MD, MPH, head of research and development, ViiV Healthcare, in the press release. “ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the ...
- Source: drugdu
- 77
- March 8, 2024
Appeals court allows unique argument in Gilead’s legal battle over HIV meds

When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. But in Gilead’s years-long court battle over its tenofivor-based HIV meds, patients have put a unique twist on that norm with their argument that the company delayed development of a safer drug. By doing so, the company was negligent, according to the plaintiffs, despite the earlier med’s effectiveness. Now, in a decision that could raise uncertainty for manufacturers across several industries, a California appeals court determined that the plaintiff’s negligence claim can stand. The allegations date back to 2001, when Gilead launched its tenofovir disoproxil fumarate- (TDF) based HIV med. While effective in HIV treatment, users of TDF risked adverse events such as skeletal and kidney damage. Around the same time, the company discovered a similar but safer candidate called tenofovir alafenamide fumarate (TAF), according to the plaintiffs. After ...
- Source: drugdu
- 81
- January 16, 2024
Novartis shares promising phase 3 results for BTK inhibitor in chronic hives

Novartis has shared positive top-line results from two late-stage studies evaluating its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. Affecting 40 million people worldwide, CSU is a debilitating and unpredictable condition characterised by the occurrence of itchy hives and/or deep tissue swelling that lasts for six weeks or longer. H1-antihistamines are the first-line treatment for the condition; however, approximately 60% of patients are inadequately controlled by these alone and continue to live with the distressing symptoms of CSU. Novartis’ remibrutinib works by blocking the cascade of BTK, an enzyme central to the release of histamine and, when spontaneously activated, plays a critical role in the symptoms associated with CSU. The ongoing phase 3 REMIX-1 and REMIX-2 trials met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, demonstrating clinically ...
- Source: drugdu
- 116
- August 12, 2023

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