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ViiV Healthcare, a global HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer (NYSE: PFE), presented today at the 22nd International Conference on HIV AIDS in Amsterdam. Results of Phase III studies GEMINI 1 and 2, evaluating the safety and efficacy of a two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) compared to a regimen of three drugs of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate / emtricitabine (TDF / FTC), in treatment-naive HIV-1 infected adults with an initial viral load of 500,000 copies per milliliter (c / mL).
Studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA
Pedro Cahn, principal investigator for the GEMINI study program said: "Since -20 years, the standard of care for HIV revolves around three diets.Now that we have more powerful drugs, the focus is on tolerance and convenience.GEMINI studies show that we can get the Efficacy of three drugs in a two-drug regimen with the tolerability and drug interaction profile of DTG and 3TC. These are important findings for people living with HIV who will spend their lives taking medications The studies have the potential to broaden the treatment paradigm for the front-line treatment of people living with HIV. "
The results show broadly consistent results. ts for viral suppression in individuals with high viral load (more than 100,000 copies of viral RNA per milliliter of plasma [>100,000 c/mL]) and lower viral load (
). The percentage of patients who withdrew due to adverse events was 2% in each arm (GEMINI 1 DTG + 3TC arm n = 7, GEMINI arm 1 DTG + TDF / FTC n = 8, GEMINI 2 DTG + 3TC arm n = 8, GEMINI 2 DTG + arm TDF / FTC n = 8) The pooled results show that the most common adverse events (≥5%) in the studies were headache, diarrhea and nasopharyngitis in both arms. (DTG + 3TC arm: 10%, 9% and 8%, respectively, DTG + TDF / FTC: 10%, 11% and 11%, respectively) .1
Drug-related adverse events were less common in patients under DTG / 3TC (126/716, 18%) than in those under DTG + TDF / FTC (169/717, 24%) 1
John C. Pottage, Jr., MD, Scientific and Medical Director ViiV Healthcare said, "This data we presented at AIDS 2018 provides further evidence that we should rethink the traditional approach to treatment. t HIV using three or more drugs. The results of the GEMINI program support our belief that the two-drug regimen of dolutegravir and lamivudine may be a valid option for patients who have never received treatment and that no patient should take more medications. as necessary.
ViiV Healthcare intends regulatory approval for a fixed-dose combination of DTG and 3TC later this year. DTG and 3TC, as 2DR, are not yet approved for use by the US FDA.
– Ends –
Notes to Publishers
Conception of GEMINI 1 & 2
The GEMINI studies are part of ViiV Healthcare's innovative clinical trial program, which aims to increase the overall evidence supporting the use of two drug regimens for HIV treatment, in order to ensure that No patient takes more medication than necessary. GEMINI studies have been ongoing for 148 weeks
GEMINI 1 (204861) and GEMINI 2 (205543) are double, phase III, randomized, double-blind, multicenter, parallel group, non-inferiority studies. These studies evaluate a two-drug regimen of dolutegravir and lamivudine compared to a regimen of three first-line drugs of DTG + TDF / FTC in adult participants infected with HIV-1 and treated with antiretroviral (ART) -navir with a HIV-1 viral reference. charge up to 500,000 copies per ml. The studies are designed to demonstrate the non-inferior efficacy, safety and tolerability of dolutegravir and lamivudine once daily compared to once-daily dolutegravir and the TDF fixed combination. / FDC at 48 weeks in patients with HIV infection.
For more information, please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on www.clinicaltrials.gov .
AMERICAN INDICATIONS AND IMPORTANT SAFETY INFORMATION
About Tivicay ® (dolutegravir)
Dolutegravir (Tivicay) is an inhibitor of Integrase strand transfer (INSTI) intended to be used in combination with other antiretrovirals for the treatment of HIV. Integrase inhibitors block the replication of HIV by preventing viral DNA from integrating into the genetic material of human immune cells (T cells). This step is essential in the HIV replication cycle and is also responsible for establishing a chronic infection. Tivicay is approved in more than 100 countries in North America, Europe, Asia, Australia, Africa and Latin America.
TIVICAY (dolutegravir) tablets
Professional indication (s) and important safety Information
United States Indications and use
TIVICAY is an inhibitor of human immunodeficiency virus (HIV-1) integrase strand transfer (INSTI) indicated in badociation with:
- other antiretrovirals for the treatment of HIV. 39; HIV-1 infection in adults and pediatric patients weighing at least 30 kg
- rilpivirine as a complete treatment of HIV-1 infection in adults to replace the diet antiretroviral therapy in virologically suppressed patients (HIV-1 RNA
). Tivicay (dolutegravir)
The following ISI is based on the Highlights section of the prescription information for Tivicay Please consult the complete prescribing information for all safety information tagged for Tivicay.
Contraindications ]
- Anterior hypersensitivity reaction to dolutegravir
- Coadministration with dofetilide.
Warnings and Precautions
- Hypersensitivity Reaction There have been reports of rash, constitutional abnormalities and sometimes organ dysfunction, including liver damage. Stop TIVICAY and other suspected agents immediately if signs or symptoms of hypersensitivity reactions occur, as delay in discontinuation of treatment may result in a life-threatening reaction.
- Cases of hepatotoxicity have been reported in patients receiving dolutegravir. Patients with underlying hepatitis B or C may have an increased risk of worsening or developing transaminase elevations. Hepatotoxicity monitoring is recommended
- Immune reconstitution syndrome has been reported in patients treated with antiretroviral combination therapy
Adverse Reactions
The most common adverse reactions in patients with Moderate to severe intensity and incidence (in those who receive TIVICAY in an adult trial) are insomnia, fatigue, and headache.
Drug Interactions
- Refer to complete dosing instructions for important drug interactions with TIVICAY. TIVICAY should be taken 2 hours before or 6 hours after taking antacids or laxatives containing cations, sucralfate, oral supplements containing iron or calcium, or buffered medicines. Alternatively, TIVICAY and supplements containing calcium or iron may be taken with food
Use in Specific Populations
- Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. Breast-feeding: Breastfeeding is not recommended
Complete dosage information in the United States is available at:
https: //www.gsksource. com / pharma / content / dam / GlaxoSmithKline / US / en / For a summary of product characteristics, please visit:
https: //www.medicines. org.uk/emc/medicine/28545[19459011_
About Epivir ® (lamivudine)
Lamivudine is a nucleoside badogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in generic (Epivir) and generic form. The trademarks are owned or licensed by ViiV Healthcare Group of Companies.
EPIVIR 300 mg, TABLETS
Professional indication (s) and important safety information
US Indications and Uses [19659003] EPIVIR is a nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV
Important Safety Information (ISI): Epivir Tablets (Lamivudine) [19659003] The following ISI is based on the Highlights section of the dosage information for Epivir. Please refer to the complete dosage information for all safety information labeled for Epivir.
Attention: Exacerbations of hepatitis B, and different formulations of Epivir
See full prescribing information for complete warning under box
- ] Severe acute exacerbations of hepatitis B have been reported in patients co-infected with the hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1) and stopped the EPIVIR. Closely monitor for liver function in these patients and, if appropriate, initiate hepatitis B treatment.
- Patients infected with HIV-1 should receive only oral dosage forms. EPIVIR appropriate for the treatment of HIV-1.
Contraindications
- EPIVIR is contraindicated in patients with pre-lamivudine hypersensitivity reaction
Warnings and Precautions
- Co-infected HIV-1 / HBV Patients: The emergence of lamivudine-resistant HBV variants badociated with antiretroviral regimens containing lamivudine has been reported
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside badogues. , some of which have been fatal, have occurred in patients co-infected with HIV-1 / HCV receiving interferon and ribavirin therapy. Monitor the toxicities badociated with the treatment. Stop EPIVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or pancreatitis. other important risk factors for pancreatitis. Stop treatment as clinically appropriate. (5.4)
- Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
- Lower rates of virologic suppression and increased risk of viral resistance have been observed in children treated with EPIVIR concomitantly with other antiretroviral solutions. with those who have received tablets. All-tablet therapy should be used where possible
Adverse Reactions
- The most commonly reported adverse reactions (incidence greater than or equal to 15%) in adults were: headache, nausea, malaise, and fatigue , nasal. signs and symptoms, diarrhea and cough.
- The most commonly reported adverse events (incidence greater than or equal to 15%) in children were fever and cough.
Drug Interactions
- Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; Breast-feeding: HIV-infected women should be informed not to badfeed because of the risk of HIV transmission.
:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Epivir/pdf/EPIVIR-PI-PIL.PDF [19659074] For EU summary of product characteristics, please visit:
https://www.medicines.org.uk/emc/product/943
About from ViiV Healthcare
ViiV Healthcare is a global HIV company founded in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) to provide treatment and care to people living with HIV . people who may be infected with HIV. Shionogi joined as a shareholder in October 2012. The company's goal is to take an interest in HIV / AIDS more deeply than any other company and take a new approach to providing effective and innovative medicines for HIV treatment and prevention, as well as supporting communities affected by HIV.
For more information on the company, its management, its portfolio, its pipeline and its commitment, please consult www.viivhealthcare.com .
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