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No impact on CV exports due to the West Asia tensions: Ashok Leyland
No impact on CV exports due to the West Asia tensions: Ashok Leyland

Business Standard

time4 days ago

  • Automotive
  • Business Standard

No impact on CV exports due to the West Asia tensions: Ashok Leyland

Ashok Leyland does not foresee any impact from recent geopolitical tensions in West Asia on its commercial vehicle (CV) exports, with shipments continuing as usual to key markets in the region, Sanjeev Kumar, president of Medium & Heavy Commercial Vehicles (M&HCV) at Ashok Leyland, said on Tuesday. 'As of now, no. There has been no impact on exports. They are going on as usual,' Kumar told Business Standard in an interview. The company has a 'fairly strong presence' in the Gulf Cooperation Council (GCC) countries and also exports to Africa, he added. In FY25, around 8 per cent of Ashok Leyland's total production was exported, while the remaining 92 per cent was sold in the domestic market. The company exported 15,255 units during the year, marking a robust 28.7 per cent year-on-year growth. Kumar also downplayed the effect of rising crude oil prices—linked to tensions in the West Asian region—on the domestic CV industry. He noted that diesel prices have remained stable for the past two to three years, offering predictability for fleet operators. 'What the industry wants is constant pricing. How does it help the CV operator? He knows what his expenses will be and, on that basis, engages with customers. This frequent up and down in crude prices will not have an impact. These are very temporary, event-driven issues,' he said. 'Three years back, when diesel prices were set, crude prices were at a higher level. So, I don't think we can expect anything negative in terms of crude right now,' he added, while acknowledging that sustained high crude prices could push up input costs like rubber. Kumar was speaking on the sidelines of a company event in New Delhi, where Ashok Leyland outlined plans to strengthen its footprint in northern India. The company is targeting an increase in its M&HCV market share in the region from 26 per cent currently to 30 per cent over the next two to three years. Ashok Leyland, the flagship company of the Hinduja Group, currently operates nearly 300 channel outlets in northern India and plans to add over 50 touchpoints this year. 'Northern India is the largest market for the commercial vehicle sector and contributes to more than a third of the total industry volume,' Kumar said during the event. The company has gained nearly 6.5 percentage points of market share in the region over the past three years, driven by various factors including cost efficiency, he said. Looking ahead, Ashok Leyland plans to continue investing in new technologies and product development while capitalising on infrastructure growth and freight mobility demands in the region.

Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America
Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America

Yahoo

time4 days ago

  • Business
  • Yahoo

Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America

C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the first patient was dosed in the global Phase 3 C-FORWARD trial evaluating the combination regimen of bemnifosbuvir and ruzasvir compared to the regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV). C-FORWARD, the second of two Phase 3 trials comparing this regimen, is being conducted at study sites outside of North America. Atea initiated C-BEYOND, the Company's Phase 3 trial in the US and Canada in April 2025 and continues to enroll patients in that study. In both studies, the regimen of bemnifosbuvir and ruzasvir is being administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is being administered orally once-daily for 12 weeks. 'We are pleased to reach another important milestone for our global HCV program with the first patient dosed in C-FORWARD, our HCV Phase 3 trial being conducted outside North America. Our Phase 3 program is now enrolling patients on a global basis,' said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea. 'We are focused on the successful development of a potential best-in-class HCV regimen that may make it easier to treat and cure patients infected with HCV. The target profile of our regimen is particularly well suited for both patients and healthcare providers in test-to-treat models of care, which enables seamless diagnosis and treatment for patients infected with HCV.' HCV continues to be a significant global health burden despite the availability of direct-acting antivirals, with an estimated 50 million people worldwide chronically infected with HCV, and approximately one million new infections each year. It is estimated that between 2.4 to 4 million people in the US alone are living with chronic HCV. 'It has been nearly a decade since the last generation of treatments for HCV became available to patients and in this time, the patient population and what they need to obtain a cure has evolved. Many patients infected with HCV are taking concomitant medications, including some that may not be recommended with the currently available HCV therapies,' said Dr. Eric Lawitz, MD, The Texas Liver Institute, Clinical Professor of Medicine, University of Texas Health San Antonio. 'The regimen of bemnifosbuvir and ruzasvir may offer a potent and more convenient option for my patients and may also make treatment more accessible for any patient who tests positive for HCV. I look forward to seeing the Phase 3 results when they are available.' 'The evolving HCV patient population and rising burden of untreated HCV in Europe mirrors trends seen in North America. Many patients present with co-morbidities and complex medical histories, with treatment decisions often influenced by concomitant medications,' said Tarik Asselah, MD, PhD, a principal investigator in the C-FORWARD trial and a Professor of Hepatology, Hôpital Beaujon, Assistance Publique–Hôpitaux de Paris (AP-HP), University of Paris-Cité, France. 'To truly advance HCV eradication and meet the needs of today's patients, an ideal treatment would combine high efficacy, short duration, and minimal risk of drug-drug interactions." Atea hosted a virtual HCV panel discussion with key opinion leaders (KOLs) on May 14, 2025. A panel of six experts, including leading hepatologists and prescribers from the US, Canada and Europe, discussed the current challenges for patients infected with HCV and the results from Atea's global Phase 2 study evaluating the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor were reviewed. Company management also reviewed the HCV commercial market opportunity and the design for the global Phase 3 clinical development program. To listen to the replay of the KOL event, please click here. About the Phase 3 C-BEYOND and C-FORWARD Trials in Adults with Chronic HCV Atea is conducting two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial is expected to enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials are comparing the fixed dose combination (FDC) regimen of bemnifosbuvir and ruzasvir to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is being administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is being administered orally once-daily for 12 weeks for all patients with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. Last month, at the European Association for the Study of the Liver (EASL) Congress 2025, Atea presented results from the full cohort of patients (n=275) enrolled in its Phase 2 study evaluating the regimen. These results showed a robust 98% (210/215) SVR12 with the regimen in the 'Per-Protocol Treatment-Adherent Population.' The SVR12 rate was 95% (245/259) in the 'Per-Protocol Regardless of Adherence Population' (also referred to as the 'efficacy evaluable population'), which included patients who were not treatment adherent (17%). Results from three additional Phase 1 studies demonstrated that the combination of bemnifosbuvir and ruzasvir had a low risk of drug-drug interactions (DDIs) and supported the safety of the regimen in HCV patients co-infected with human immunodeficiency virus (HIV) taking a standard HIV treatment, and the safety of bemnifosbuvir in participants with hepatic or renal impairment with no need for dose adjustments. About HCV HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. A leading cause of chronic liver disease and liver transplants, HCV is mainly spread via blood transfusion, hemodialysis and needle sticks, with 242,000 deaths occurring each year. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. In the US, HCV infections predominate in patients in the age group between 20-49 years old, and it is estimated that fewer than approximately 10% of patients have cirrhosis. About Bemnifosbuvir and Ruzasvir for HCV Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. In both nonclinical and clinical studies, bemnifosbuvir has been shown to have a low risk for DDIs. Bemnifosbuvir has been administered to over 2,300 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 2,100 subjects at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About Atea Pharmaceuticals Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea's lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit Forward Looking Statement This press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV and the potential to develop a regimen that makes it easier to treat and cure HCV patients. When used herein, words including 'expected,' 'should,' 'anticipated,' 'believe,' 'will,' 'plans', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea's current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial product, competition from approved treatments for HCV, the timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea's most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of HCV; as well as the other important factors discussed under the caption 'Risk Factors' in Atea's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea's views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Joyce AllaireLifeSci AdvisorsJallaire@ in to access your portfolio

Design Health Services Around People, Not The Disease
Design Health Services Around People, Not The Disease

Scoop

time5 days ago

  • Health
  • Scoop

Design Health Services Around People, Not The Disease

"We need to design services around people, not the disease," rightly said Dr Nittaya Phanuphak. Unless point-of-care health technologies are deployed for those who are most-in-need in a person-centred and rights-based manner, we would fail to deliver on the promises enshrined in #HealthForAll and SDGs goals and targets. "Point-of-care health technologies sitting in centralised laboratories are as good as centralised, lab-dependent ones - both remain inaccessible to those in acute need," said Shobha Shukla. "But when point-of-care tools are taken and deployed as close as possible to the communities to serve them with equity and human dignity, real change happens." Shobha and Dr Nittaya were speaking at the 2nd Asia Pacific Conference on Point-of-Care Diagnostics for Infectious Diseases (POC 2025) and in lead up to the 13th International AIDS Society Conference on HIV Science (IAS 2025). Dr Nittaya Phanuphak is the Convener of POC 2025; Executive Director of Institute of HIV Research and Innovation (IHRI) and Governing Council member of International AIDS Society (IAS). Shobha leads CNS (Citizen News Service) and Chairs Global Antimicrobial Resistance Media Alliance (GAMA). Community-led models proved same day "test and treat" for HCV is feasible and effective In India's Manipur, Community Network for Empowerment (CoNE) and partners did a path-breaking study to prove that same day "test and treat" is possible, feasible and effective for hepatitis C virus (HCV). They could do so because for the confirmatory test, the sample did not have to go for centralised laboratories but could be tested on WHO recommended point-of-care, decentralised, battery-operated (with solar power recharging capabilities) and laboratory independent multi-disease molecular testing platform, Truenat. So, when confirmatory test Truenat could be deployed closer to the communities, it became possible to screen people, and offer molecular test on Truenat to those who needed a confirmatory test on-spot. Result came back within an hour after which treatment initiation could be followed upon. Giten Khwairakpam, one of the study co-authors who works with amfAR's TREATAsia programme, was speaking at POC 2025. Truenat is made in India by Molbio Diagnostics, is the largest used molecular test for TB in India (and also deployed in over 85 countries globally), and over 9000 machines are deployed by the government (for TB) across India. This study enrolled 643 people (during November 2021 to August 2022) out of which 503 were screened - all were males and had a history of injection drug use. Community people who formerly had a history of injection drug use conducted the screening. 155 people were found to have viraemia, out of which 98% (153) were initiated on treatment on the same day (remaining 2 people also were initiated on treatment soon after). All (100%) completed the treatment. All (100%) those who tested negative were offered vaccination for hepatitis B virus. It is a powerful example from the communities which should inform national and global policies for improving hepatitis responses on the ground - in person-centred manner. Philippines' Bantayan offers another strong example when point-of-care tools are deployed at point-of-need In multiple islets of Bantayan in the northernmost part of Cebu, Philippines, only around one-third of the estimated TB cases could be notified before the pandemic. But after the introduction of new TB screening and diagnostic tools, now almost all the TB (99%) is found in 2024. Dr Samantha Tinsay, government Municipal Health Officer, Bantayan, Cebu, Philippines and her team made a major difference in bridging the gap between TB services and people who were left behind on islets of Bantayan. She took point-of-care and battery operated AI-CAD enabled X-Rays and Truenat (point-of-care, battery-operated, laboratory independent and de-centralised molecular test) - both kept safely in a moulded plastic box - loaded on a pump boat - and went from islet to islet - screening people for TB and offering confirmatory Truenat molecular test on the spot. Within an hour or so, those found with active TB disease were linked to TB treatment care pathway. New TB case notifications, as well as treatment success rate, increased manifold. But the journey was not easy - also due to inclement weather and stormy seas. Dr Samantha's untiring efforts have resulted in a tremendous increase in TB case finding: the number of persons screened for presumptive TB went up from 187 (in 2019) to 2506 (in 2022), 2027 (in 2023), and 5679 people in 2024. 'TB treatment success rate has also increased to 97% in 2023,' she confirmed. Average TB treatment success rate in the Philippines was 78% in 2023 as per the WHO Global TB Report 2024. Imagine the difference it can make in the Philippines' response to end TB if such interventions can be scaled up and become a norm. Dr Darivianca Elliotte Laloo, who has earlier served at the Stop TB Partnership and International Union Against Tuberculosis and Lung Disease (The Union) and currently leads Molbio Diagnostics as General Manager, chaired this session at POC 2025. She said that Truenat, which was validated independently by the Indian Council of Medical Research of the Government of India in 2017, offers PCR molecular testing for over 40 diseases (including current strains of COVID-19). Being WHO recommended battery-operated, laboratory independent, decentralised and point-of-care molecular test for TB with solar power charging capacities, it is increasingly getting deployed in peripheral areas of several high-burden countries now. Largest rollout of Truenat in Africa took place in Nigeria last December. Nigeria is home to largest number of people with TB in Africa. We need to close the gap between people-in-need and point-of-care standard diagnostics by taking services closer to them or at their doorstep, said Dr Laloo. Colossal cost of misdiagnosis on communities Noted #endTB activist Blessina Kumar who leads Global Coalition of TB Advocates (GCTA) shared a powerful real-life testimony of Meera, who survived one of the most serious forms of drug-resistant TB (Extensively Drug-Resistant TB or XDR-TB). If someone had XDR-TB in 2012, there were tools back then too, to test for TB and drug-resistant TB within 100 minutes. And after drug-susceptibility testing (to ensure that TB bacteria is sensitive to medicines used in the therapy), an effective treatment could have helped Meera towards cure. But misdiagnosis caused havoc: She had to endure the rigours of going through TB treatment for six years (2012-2018). She also had to spend around INR 300,000 (~USD 4000) as well which is a grim reminder that delayed or wrong diagnosis often results for catastrophic costs for people in need. She also had to be stay away from her 4 months old son because of TB. TB stigma and discrimination also did not spare her: she was not allowed in the kitchen or living room, and had to use separate utensils and clothes. She not only battled depression but also attempted suicide twice. Experts say that soon after initiation of an effective TB treatment, a person becomes non-infectious. But TB stigma and discrimination still lurks. After 6 years, Meera finally got the right diagnosis and treatment, and could get cured. She advocates for person-centred TB care since then. In 2025, if anyone has XDR-TB or any other form of drug-resistant TB, it should take an hour or two for confirmatory TB test (upfront molecular test) and treatment hopefully will be over in next six-months using the latest WHO recommended regimen - and with full health and social care and support. Imagine the difference it can make if we deploy science-based standard healthcare tools to serve the people where they are in person-centred manner. Inequities and injustices firewall most-in-need people from accessing standard care "It is not lack of TB diagnostic, treatment and prevention tools that are causing human suffering and killing people but inequity and injustices that plague our world. For example, rich nations like Australia could bring down TB rates to elimination level 50 years ago with whatever tools they had. In USA, lab on wheels with X-Rays were going to remote areas to find more TB in 1950s," said Shobha Shukla. "I have myself seen TB pins of 1940s and 1950s that were worn by people in USA to declare that they had taken an X-Ray to screen for TB." But, in the Global South, even after 50-70 years - it is not so common as it should be - to see lab on wheels taking an (AI-CAD enabled) X-Ray and molecular test closer to the unreached people with standard TB services. WHO called upon all governments in 2018 to replace microscopy with 100% upfront molecular testing for TB by 2027. All world leaders agreed to do so too in their Political Declaration of United Nations General Assembly High-Level Meeting on TB 2023. Despite this, out of those who got diagnosed, more than half (52%) did not get upfront molecular test in 2023 – rather they got microscopy or were not bacteriologically confirmed at all. Most of them would be in the Global South, wonders Shobha. "Early and accurate diagnostics is the ONLY entry-gate towards TB treatment care pathway. It reduces catastrophic costs faced by the most vulnerable, reduces avoidable human suffering and risk of TB death and helps stop the spread of TB infection," she said. 100 days campaign in India heralds a foundational shift on how we find TB based on science and evidence India's TB Prevalence Survey 2019-2021 showed that almost half of TB patients were asymptomatic. The Indian govt-led 100 days campaign from 7 December 2024 to 24 March 2025 was launched in 347 most affected districts to screen everyone regardless of symptoms among high-risk populations, including homeless and migrants. After 24 March 2025, given the impact, it was expanded to all 806 districts nationwide. As per government's concept note of 100 days campaign, vans were to go closer to high-risk groups with Artificial Intelligence Computer-Aided Detection (AI-CAD) enabled portable X-rays, Truenat molecular test machines for sputum testing, and other tests as required. 129.7 million people were screened and over 285,000 asymptomatic people with active TB disease were found – all of whom would have been missed if AI-CAD enabled X-ray was not done. "Imagine the public health impact of stopping TB spread, reducing human suffering and putting an additional nearly 300,000 to path of healing perhaps," said Shobha. Walk-the-talk on multi-disease elimination approach "As WHO multi-disease elimination approach is being finalised, we need to recognise that we have a lot of under-utilised multi-disease tools which we use for TB only. Truenat offers molecular testing for over 40 diseases. Likewise, artificial intelligence we use for TB detection, such as DeepTek's Genki and QureAI, both screen people within seconds for a number of diseases (DeepTek's Genki screens for more: 26 pathologies)," said Shobha. "Let us be responsible and fully optimally utilise diagnostic infra we have at point-of-need and scale them up too. It helps with pandemic prevention, preparedness and response too." And with regards to TB, follow the science – screen everyone in high-risk settings in people-centred manner. Bobby Ramakant – CNS (Citizen News Service) (Bobby Ramakant is part of CNS (Citizen News Service) and a World Health Organization (WHO) Director General's WNTD Award 2008. He is also on the Board of Global AMR Media Alliance (GAMA) and Asia Pacific Media Alliance for Health and Development (APCAT Media). Follow him on X: @bobbyramakant)

The Progression of Hepatitis C: What Are the Stages?
The Progression of Hepatitis C: What Are the Stages?

Health Line

time20-06-2025

  • Health
  • Health Line

The Progression of Hepatitis C: What Are the Stages?

Key takeaways Every case of hepatitis C begins as an acute infection. Infections that last more than 6 months are considered chronic. Many people with hepatitis C end up with chronic hepatitis C that can last a lifetime. The consequences of long-term infection include liver damage, liver cancer, and even death. Early detection and treatment are key for stopping the progression of hepatitis C and avoiding major complications. Hepatitis C is an infection caused by the hepatitis C virus (HCV) that leads to liver inflammation. Symptoms can be mild for many years, even while liver damage is taking place. Many people with hepatitis C end up with chronic hepatitis C that can last a lifetime. The consequences of long-term infection include liver damage, liver cancer, and even death. Early detection and treatment are key for stopping the progression of hepatitis C and avoiding major complications. How HCV is transmitted HCV is a bloodborne pathogen. That means the virus is transmitted through contact with blood that contains HCV. To reduce your risk of exposure: Avoid sharing razors, nail clippers, toothbrushes, and other personal hygiene items. Avoid sharing needles, syringes, and other sharps. Disinfect wounds and surfaces touched by blood and other bodily fluids as soon as possible. Patronize tattoo and body piercing studios that practice proper sterilization practices. HCV usually isn't transmitted through sexual contact, but it's possible. Using condoms, gloves, and other barrier methods during sexual activity can help reduce your risk. Birthing parents with HCV can also transmit the virus during childbirth, but not through nursing. Early warning signs In most cases, there are no early warning signs. Most people are symptom-free and remain unaware of the infection. Others experience mild symptoms, such as fatigue and loss of appetite, which tend to resolve independently. According to the World Health Organization (WHO), around 30% of people clear the infection within 6 months of exposure without medical intervention. Acute hepatitis C The acute phase of hepatitis C is the first 6 months after contracting HCV. Early symptoms may include: fever fatigue loss of appetite nausea and vomiting In most cases, symptoms clear up within a few weeks. If your immune system doesn't fight the infection on its own, it enters the chronic phase. Given the vague nature of the symptoms, hepatitis C may go unnoticed for years. It's often discovered during a blood test that's being done for other reasons. Chronic hepatitis C Approximately 70% of people will go on to develop chronic hepatitis C. However, even in the chronic phase, it may take years for symptoms to show. The progression begins with inflammation of the liver, followed by the death of liver cells. This causes scarring and hardening of liver tissue. Roughly 15–30% of people with chronic hepatitis C go on to develop cirrhosis of the liver within 20 years. Cirrhosis of the liver When permanent scar tissue replaces healthy liver cells, and your liver loses the ability to function, it's called cirrhosis. In this condition, your liver can no longer heal itself. This can cause fluid to build up in your abdomen and the veins in your esophagus to bleed. When the liver fails to filter toxins, they can build up in your bloodstream and impair brain function. Cirrhosis of the liver can sometimes develop into liver cancer. This risk is greater in people who drink excess alcohol. Treatment of cirrhosis depends on the progression of the condition. End-stage hepatitis C Chronic hepatitis C can cause serious long-term health consequences when it leads to liver scarring. End-stage hepatitis C occurs when the liver is severely damaged and can no longer function properly. Symptoms may include: fatigue nausea and vomiting loss of appetite abdominal swelling yellowing of the skin and eyes (jaundice) muddled thinking People with cirrhosis may also experience bleeding in the esophagus, as well as brain and nervous system damage. A liver transplant is the only treatment for end-stage liver disease. Factors that affect the progression Because alcohol is processed in the liver, consumption of excess alcohol can hasten liver damage, so it's important not to drink it. Damage also progresses faster in people with weakened immune systems, such as those with HIV. People who also have hepatitis B are at an increased risk of developing liver cancer. Males who have cirrhosis tend to experience faster disease progression than females. People over 40 with cirrhosis also experience faster disease progression than younger people. If you suspect that you have hepatitis C, consult with a healthcare professional as soon as possible. Early detection and treatment are the best ways to prevent and treat any serious complications or progression. Frequently asked questions What is the life expectancy of a person with hepatitis C? Many people live for years after receiving a hepatitis C diagnosis. Your outlook ultimately depends on the stage at diagnosis, whether liver damage has occurred, and your overall health. How many people experience long-term complications of hepatitis C? According to the Centers for Disease Control and Prevention, approximately 5–25 out of every 100 people who have hepatitis C develop cirrhosis within 10–20 years. People who develop cirrhosis have a 3–6% annual risk of hepatic decompensation or 'decompensated' cirrhosis. This occurs when your liver function decreases and may be a sign of end-stage hepatitis C. People who develop cirrhosis also have a 1–4% annual risk of developing hepatocellular carcinoma, which is the most common type of primary liver cancer. What are the chances of dying from hepatitis C? Hepatitis C alone typically isn't fatal, but complications from untreated or advanced hepatitis C can be. People who develop decompensated cirrhosis, for example, have a 15–20% risk of death within a year of diagnosis. If you have questions about your outlook, talk with your healthcare professional. They're the only person with direct insight into your diagnosis and medical history.

FDA approves label expansion of AbbVie hepatitis C therapy
FDA approves label expansion of AbbVie hepatitis C therapy

Yahoo

time13-06-2025

  • Health
  • Yahoo

FDA approves label expansion of AbbVie hepatitis C therapy

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie's Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. The extended indication for this oral pangenotypic direct-acting antiviral (DAA) therapy involves those who have the infection without cirrhosis or with compensated cirrhosis. The therapy is the first and only DAA treatment approved for this patient group. HCV is a blood-borne infectious disease that can lead to serious liver complications. The agency's approval is based on data from a Phase III, single-arm, prospective multicentre trial that evaluated the efficacy and safety of an eight-week treatment of the therapy in adults with acute HCV infection. Findings from the trial demonstrated that the therapy is a highly efficacious treatment option. AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar stated: "Mavyret has treated more than one million patients with HCV, but we recognise that a significant need remains for patients with acute infection. "The label expansion for Mavyret, coupled with the implementation of 'test and treat' models of care, serves as a tool to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal." Mavyret had also secured a breakthrough therapy designation from the US regulator for acute HCV. This status expedites the development and review of medicines intended to treat serious conditions when preliminary clinical evidence suggests substantial improvement over current therapies. In May 2025, AbbVie signed a partnership and licensing agreement with US-based ADARx Pharmaceuticals, committing $335m upfront to access its small interfering RNA platform. "FDA approves label expansion of AbbVie hepatitis C therapy" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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