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Bütün meleklerinin kanadını kendisi kıracaktı. En büyük günahlar hep melek olanlarındı
Previously, kids weighing 44 to 88 pounds had to take lower doses—which are less available worldwide—and do so more than once a day.
Children living with HIV who weigh at least 44 pounds can safely take the adult dose of the key integrase inhibitor dolutegravir.
This finding from a new study conducted among children in sub-Saharan Africa means that antiretroviral (ARV) dosing for many HIV-positive children can be considerably simplified, thus improving access to treatment. Previously, children younger than 12 or those weighing less than 88 pounds had to take dolutegravir (sold under the brand name Tivicay) at doses lower than the 50 milligram dose approved for adults. And unlike adults, these children had to take those pills more than once a day.
Dolutegravir Prices | Pricing | Trend | News | Database | Chart | Forecast
Dolutegravir is an antiretroviral medication primarily used in the treatment of HIV/AIDS. As part of the class of drugs known as integrase inhibitors, Dolutegravir works by blocking the action of an enzyme called integrase, which the HIV virus uses to replicate. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, Dolutegravir has become a crucial component in many HIV treatment regimens. However, one of the most significant concerns around the world, especially in low-income and middle-income countries, has been the pricing of Dolutegravir. Pricing influences access to this essential medication, and efforts are ongoing to make it more affordable for those who need it most.
The cost of Dolutegravir varies widely depending on geographic location, patent laws, and whether the drug is branded or generic. In high-income countries such as the United States, Dolutegravir is often sold under the brand name Tivicay, manufactured by ViiV Healthcare. The brand-name version of Dolutegravir tends to be expensive, with prices in the U.S. being notably higher than in other regions. For example, a month's supply of Tivicay can cost thousands of dollars. This high cost is driven by research and development expenses, regulatory costs, and the need to recoup the investment in bringing a new drug to market. However, the high cost in wealthier nations often makes it difficult for those without adequate health insurance or government assistance to access the medication.
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In contrast, many low- and middle-income countries rely on generic versions of Dolutegravir, which are significantly less expensive. Generic Dolutegravir became available after licensing agreements and patent waivers were negotiated between pharmaceutical companies, non-governmental organizations, and international agencies. These agreements allowed for the production of more affordable versions of the drug, making it accessible to larger populations. In countries such as India, which has a robust generic pharmaceutical industry, the price of Dolutegravir can be as low as a few dollars per month. This drastic reduction in price has been crucial in improving access to HIV treatment, particularly in regions that are heavily burdened by the epidemic, such as sub-Saharan Africa.
Global health organizations like the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have played a pivotal role in advocating for lower prices for HIV medications, including Dolutegravir. The Medicines Patent Pool (MPP) is another initiative that has helped to lower the cost of Dolutegravir. By facilitating voluntary licensing agreements, the MPP enables generic drug manufacturers to produce and sell Dolutegravir at a fraction of the price of the branded version. These efforts have resulted in broader availability of the drug, but challenges remain in ensuring that everyone who needs Dolutegravir can afford it.
The introduction of Dolutegravir as part of first-line HIV treatment regimens in many countries has been a game-changer. Not only is Dolutegravir highly effective in suppressing the HIV virus, but it also has a high barrier to resistance, meaning that patients are less likely to develop resistance to the drug over time. Moreover, Dolutegravir has fewer side effects compared to older antiretroviral medications, making it a preferred option for many patients and healthcare providers. Given its effectiveness, there has been a global push to make Dolutegravir the standard of care in HIV treatment. However, pricing remains a barrier in some parts of the world, where even the generic versions may be out of reach for the most vulnerable populations.
Efforts to reduce the price of Dolutegravir are ongoing, with various international partnerships and coalitions working to negotiate lower costs. For example, the Global Fund to Fight AIDS, Tuberculosis and Malaria has been instrumental in securing lower prices for Dolutegravir through bulk purchasing agreements. These agreements allow for large quantities of the drug to be purchased at a reduced cost, which can then be distributed to countries in need. Additionally, some countries have implemented pricing controls or subsidies to make Dolutegravir more affordable for their populations. These strategies have been successful to varying degrees, depending on the political and economic landscape of each country.
Another factor influencing the price of Dolutegravir is the expiration of patents. As patents on the drug begin to expire in more countries, the opportunity for increased competition among generic manufacturers grows. This competition is expected to drive prices down even further, making Dolutegravir more accessible to a wider range of people. However, patent expirations are staggered across different regions, meaning that some countries may experience price reductions sooner than others. In countries where the patent is still in effect, advocacy efforts are focused on encouraging pharmaceutical companies to voluntarily lower their prices or enter into more licensing agreements that would allow for the production of generics.
In recent years, there has been a growing emphasis on the importance of affordable HIV treatment as part of global health initiatives. The United Nations has set ambitious goals for reducing the number of new HIV infections and ensuring that those living with HIV have access to treatment. Dolutegravir is central to these efforts, but its price remains a critical issue. Without continued pressure on pharmaceutical companies and governments, there is a risk that some populations will continue to be left behind in the fight against HIV/AIDS.
In conclusion, the pricing of Dolutegravir reflects a complex interplay of factors, including patent laws, production costs, and global health policies. While progress has been made in making the drug more affordable, particularly in low- and middle-income countries, there is still work to be done to ensure that everyone who needs Dolutegravir can access it. The future of HIV treatment depends not only on the development of new and effective medications but also on the ability to make these treatments affordable and accessible to all. Through continued international cooperation and advocacy, it is possible to further reduce the price of Dolutegravir and ensure that it reaches those who need it most.
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THE DOLUTEGRAVIR OPPORTUNITY
DTG is a relatively new ARV available in generic form in low- and middle-income countries. It is an integrase inhibitor that blocks an HIV enzyme (a protein that starts or increases the speed of a chemical reaction) called integrase. By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body. As a single dose, in conjunction with other drugs to form a regimen, 50mg DTG single has been on the market in developing countries for a couple of years. However, its relatively high price and unavailability in a triple fixed-dose form limited significant uptake. Botswana, however, was an early adopter of the DTG single through a special initiative of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).
In August 2017, the US Food and Drug Administration (FDA) provided tentative approval for two Indian generic ARV suppliers – Aurobindo Pharma and Mylan Laboratories Limited – for the fixed-dose combination of tenofovir 300mg /lamivudine 300mg /dolutegravir 50mg (TLD), reducing one barrier for adoption in developing countries.
Clinical Commissioning Policy: Dolutegravir for treatment of HIV-1 infection (all ages)
HIV treatment has improved greatly over the last two decades and standard of care now involves triple therapy, typically with two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus one of the following: a ritonavir-boosted protease inhibitor (PI/r), a non nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor.
Effective antiretroviral treatment (ART) requires high adherence to drug regimes. Development of new ARV medicines often focuses on improvements in tolerability, reductions in toxicity and drug to drug interactions.
Effectiveness of ART is measured by an undetectable viral load. The proportion of treated individuals with a viral load less than 50 has improved (94% in 2016) which may be driven, at least in part, by improvements in drug choice. Current standard treatment is therefore effective for many people. The availability of generic ART has reduced the cost of standard treatment considerably. New drug treatments need to demonstrate both clinical and cost effectiveness over standard treatments.
Dolutegravir for the treatment of pregnant women living with HIV
HIV, which stands for Human Immunodeficiency Virus, is a retrovirus that causes AIDS (Acquired Immune Deficiency Syndrome). In 2018, a total of 4,026 pregnant women living with HIV were identified, with the indication to start antiretroviral therapy (ART). The timely initiation of ART, with improved adherence and tolerability, is critical for achieving an undetectable viral load, and, consequently, preventing vertical transmission (VT) of HIV.
Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study
Although the fi rst-generation integrase inhibitors raltegravir and elvitegravir are potent and well tolerated in treatment-naive and treatment-experienced adults with HIV,1–4 improved integrase inhibitor-based therapy options would benefi t these patients. Raltegravir requires twice-daily dosing5 and has variable pharmacokinetic characteristics. Elvitegravir must be taken with food and requires coadministration with a pharmacokinetic boosting agent, creating the potential for clinically signifi cant drug interactions.6 Additionally, treatment-experienced patients who fail raltegravir-based to resistance and has shown potent effi cacy in antiretroviral-naive patients and patients with multiclass resistance.14–16 No signifi cant food eff ect or signifi cant cytochrome P450 inhibition or induction has been observed, suggesting a low potential for interactions.
We report results from ING111762 (SAILING), comparing clinical effi cacy, safety, and virology outcomes in treatment-experienced, integrase-inhibitor-naive patients who received dolutegravir 50 mg once daily or raltegravir 400 mg twice a day, plus investigator-selected background therapy.