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ViiV Healthcare, a global HIV specialty company founded in November 2009 by GlaxoSmithKline (GSK) and Pfizer (NYSE: PFE), today announced at the 22nd International AIDS Conference in Amsterdam 48 Week Results of Phase III GEMINI Studies 1 & 2 Evaluating the Safety and Efficacy of Dual-drug Therapy (2DR) of Dolutegravir (DTG) and Lamivudine (3TC) Compared to Three-drug Therapy Dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate / emtricitabine (TDF / FTC), in previously untreated HIV-1 infected adults with baseline virus outbreaks of up to 500,000 copies per milliliter (c / ml)
The studies achieved their primary endpoint of non-inferiority based on plasma HIV-1
Pedro Cahn, senior researcher for the GEMINI study program, said, "In the last 15-20 years n the standard of HIV care has focused on three drugs. Now that we have stronger drugs, the focus is shifting to comfort and convenience. The GEMINI studies show that we can obtain the efficacy of three drugs in a two-drug regimen with the tolerance and drug interaction profile of DTG and 3TC. These are important findings for people with HIV who use drugs all their lives to suppress their virus. The studies have the potential to extend the treatment paradigm for first-line treatment of people living with HIV.
The results show broadly consistent results for virus suppression in subjects with higher viral load (more than 100,000 copies of viral RNA per milliliter) of blood plasma [>100,000 c/mL]) and lower viral load (
The percentage of patients experiencing adverse events 2% in each study arm (GEMINI 1 DTG + 3TC arm n = 7, GEMINI 1 DTG + TDF / FTC arm n = 8, GEMINI 2 DTG + 3TC arm n = 8, GEMINI 2 DTG + TDF / FTC- Arm n = 8.) Pooled results show that the most common (≥5%) adverse events in the studies were headache, diarrhea, and nasopharyngitis in both arms (DTG + 3TC arm: 10%, 9%, and 8%, DTG + TDF / FTC: 10%, 11% and 11%, respectively) .1
Drug-related adverse events were less common in patients receiving DTG / 3TC therapy (126/716, 18%) compared with those receiving DTG + TDF / FTC Therapy (169/717, 24%). 1
John C. Pottage, Jr., MD, Chief Scientific and M ViiV Healthcare's Edical Officer said: "These data, presented at AIDS 2018, provide further evidence that we should reconsider the traditional approach to HIV treatment when using three or more medicines. The results of the GEMINI program support our belief that the two-drug regimen of dolutegravir and lamivudine may be a valuable option for treatment-naive patients and that no patient should take more medicine than they need. "
ViiV Healthcare intends to seek approval for a fixed dose combination of DTG and 3TC later this year." DTG and 3TC, as a 2DR, has not yet been approved for use by the US FDA.
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GEMINI 1 & 2 study design
The GEMINI studies are part of ViiV's innovative clinical study program Healthcare aims to improve the evidence for the use of two-drug therapies to treat HIV to ensure that no patient is taking more medication than they need The GEMINI trials continue for 148 weeks
GEMINI 1 (204861) and GEMINI 2 (205543) are dual, phase III, randomized, double-blind, multicentre, parallel group, non-inferiority trials that evaluate two-drug therapy with dolutegravir and lamivudine compared to one Three-line therapy with DTG + TDF / FTC in HIV-1-infected antiretroviral therapy (ART) -negative adult participants with HIV-1 parent virus will load up to 500,000 copies per ml. The studies are intended to demonstrate non-inferior efficacy, Safety and tolerability of once-daily dolutegravir and lamivudine versus once daily dalutegravir and fixed-dose TDF / FDC combination therapy after 48 weeks in HIV-1-infected ART show -naw participants
For more information, please search according to NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) under www.clinicaltrials.gov .
US INFORMATION AND IMPORTANT SAFETY INFORMATION
About Tivicay (Dolutegravir)
Dolutegravir (Tivicay) is an Integrase Strand Transfer Inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from being integrated into the genetic material of human immune cells (T cells). This step is essential for the HIV replication cycle and is also responsible for the development of 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
USA Indications and Use
TIVICAY is a human immunodeficiency virus (IST) type 1 (HIV-1) integrase strand transfer inhibitor, indicated in combination with:
- other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients with one Body weight of at least 30 kg
- Rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults for the replacement of current antiretroviral therapy with HIV-1 RNA
Important safety information: Tivicay (Dolutegravir)
The following ISI is based on the Highlights section of the prescribing information for Tivicay Please see the full prescribing information for all with e ineligible safety information for Tivicay
- Previous hypersensitivity reaction to dolutegravir
- Co-administration with dofetilide
Warnings and precautions
- Hypersensitivity reactions There have been cases of rash , constitutional findings and sometimes organ dysfunction including liver damage reported. Stop TIVICAY and other suspicious substances immediately if signs or symptoms of a hypersensitivity reaction occur, as delaying treatment discontinuation may result in a life-threatening reaction.
- Hepatotoxicity has been reported in patients treated with dolutegravir. Patients with underlying hepatitis B or C may be at increased risk of worsening or developing transaminase elevations. Monitoring for hepatotoxicity is recommended.
- Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
The most common side effects of moderate to severe intensity and incidence of at least 2% (in patients receiving TIVICAY in an adult study) Insomnia, fatigue and headache.
- See full prescribing information for important drug interactions with TIVICAY
- Metabolic inducers may decrease the plasma concentration of dolutegravir.
- TIVICAY should be taken 2 hours before or 6 hours after ingestion of cationic antacids or laxatives, sucralfate, oral supplements with iron or calcium or buffered medications. Alternatively, TIVICAY and calcium or ferric supplements may be taken with food.
Use in certain populations
- Pregnancy: TIVICAY should only be used during pregnancy if the potential benefit justifies the potential risk.
- Breastfeeding: breastfeeding is not recommended.
Full US prescribing information is available at:
https://www.gksource.com/pharma/content/dam/GlaxoSmithKline/EN/en/ Prescribing_Information / Tivicay / pdf / TIVICAY- PI-PIL.PDF
For the EU Summary of Product Characteristics, please visit:
https: //www.medicines. org.uk/emc/medicine/28545
About Epivir ® (lamivudine)
Lamivudine is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir) and generic forms. Trademarks are owned or licensed to the ViiV Healthcare group.
EPIVIR 300 mg tablets
Professional indication (s) and important safety information
US Indications and Use
EPIVIR is a nucleoside analogue Reverse transcriptase inhibitor, which is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product applies to HIV-1 and not HBV
Important Safety Information (ISI): Epivir (Lamivudine) Tablets
The following ISI is based on the Highlights section of the Epivir prescribing information , Please read the full prescribing information for all of the labeled safety information about Epivir
Warning: Hepatitis B exacerbations and various formulations of Epivir
See complete prescribing information for complete canned warnings.  Severe acute exacerbations of hepatitis B have been reported in patients coinfected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) who have discontinued EPIVIR. In these patients, liver function should be closely monitored and, if appropriate, hepatitis B treatment should be initiated.
- EPIVIR Contraindicated in Patients With Previous Hypersensitivity Reaction to Lamivudine
Warnings and Precautions
- Co-infected HIV-1 / HBV patients : The occurrence of lamivudine-resistant HBV variants has been reported in association with lamivudine-containing antiretroviral regimens.
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported using nucleoside analogues.
- Hepatic decompensation B. was partially fatal in HIV-1 / HCV-coinfected patients receiving interferon and ribavirin-based regimens. Monitor for treatment-related toxicities. Stop EPIVIR as medically indicated and consider reducing the dose or discontinuation of interferon alfa, ribavirin, or both.
- Pancreatitis: Use with caution in pediatric patients with pancreatitis or other significant risk factors for pancreatitis. Stop treatment as clinically appropriate. (5.4)
- An immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
- In pediatric patients on oral EPIVIR oral antiretroviral solutions, lower rates of virologic suppression and increased risk of viral resistance have been observed with those receiving tablets. If possible, an all-pill regimen should be used.
- The most commonly reported adverse reactions (frequency 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 reactions (Incidence greater or equal to 15%) in children were fever and cough
Interaction with other medicinal products
- Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; if possible, avoid chronic co-administration.
Use in certain populations
- Breast-feeding: HIV-infected women should be instructed not to breastfeed for possible HIV transmission.
For complete US technical information, see:
https://www.gksquare.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Epivir/pdf/EPIVIR -PI-PIL.PDF  For the EU Summary of Product Characteristics, please visit:
About ViiV Healthcare
ViiV Healthcare is a global HIV-focused company founded in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) Making progress in treating and caring for people living with HIV People at risk of becoming infected with HIV. Shionogi joined in October 2012 as a shareholder. The company's goal is to create a deeper and broader interest in HIV / AIDS than any company before, and to adopt a new approach to delivering effective and innovative HIV treatment and prevention medicines to support HIV-infected communities
Further information on company, management, portfolio, pipeline, and engagement, see www.viivhealthcare.com .