ViiV Healthcare Launches Phase III Programme Evaluating a Two-drug Regimen Combining Dolutegravir and Lamivudine for HIV

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported

Adverse Reactions: The most commonly reported (greater than or equal to2%) adverse reactions of moderate to severe intensity in treatment-naive adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).  

Drug Interactions:  

- Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce
plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
- Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing
antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or
buffered medications. Alternatively, TIVICAY and supplements containing calcium or
iron can be taken with food
- Consult the full Prescribing Information for TIVICAY for more information on
potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

EPIVIR(R) (lamivudine) tablets 

Indications and Usage 

EPIVIR is a nucleoside analogue 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 hepatitis B virus (HBV).

Important Safety Information (ISI) 

The following ISI is based on the Highlights section of the US Prescribing Information for EPIVIR. Please consult the full Prescribing Information for all the labeled safety information for EPIVIR.

BOXED WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF EPIVIR 

See full prescribing information for complete boxed warning.

-- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.

-- Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

-- Patients with HIV-1 infection should receive only dosage forms of EPIVIR appropriate for treatment of HIV-1.

CONTRAINDICATIONS 

- EPIVIR is contraindicated in patients with previous hypersensitivity reaction to
lamivudine.

WARNINGS AND PRECAUTIONS 

- Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants
associated with lamivudine-containing antiretroviral regimens has been reported.
- Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients
receiving interferon and ribavirin-based regimens. Monitor for treatment-associated
toxicities. Discontinue 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
other significant risk factors for pancreatitis. Discontinue treatment as clinically
appropriate.
- Immune reconstitution syndrome and redistribution/accumulation of body fat have been
reported in patients treated with combination antiretroviral therapy.
- Lower virologic suppression rates and increased risk of viral resistance were observed
in pediatric subjects who received EPIVIR oral solution concomitantly with other
antiretroviral oral solutions compared with those who received tablets.

ADVERSE REACTIONS  

The most common 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.

USE IN SPECIFIC POPULATIONS  

- Lactation: Breastfeeding not recommended.

1. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents; p. F-4. Available at http://www.aidsinfo.nih.gov/guidelines Last accessed August 2016

2. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach - Second edition. WHO June 2016; p. 97. Available at http://www.who.int/hiv/pub/arv/arv-2016/en  Last accessed August 2016  

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CONTACT: ViiV Healthcare Media enquiries: Sébastien Desprez, +44 (0) 208380 6275, Patricia O'Connor, Marc Meachem, +44 (0) 208 047 5982, +1 919483 8756 , GSK Global Media enquiries: David Daley, +44 (0) 20 8047 2615,Kathleen Cuca, +1 215 859 1922, GSK US Media enquiries: Mary Anne Rhyne, +1919 483 0492, Sarah Spencer, +1 215 751 3335, Analyst/Investor enquiries:Ziba Shamsi, +44 (0) 20 8047 5543, Tom Curry, + 1 215 751 5419, GaryDavies, +44 (0) 20 8047 5503, James Dodwell, +44 (0) 20 8047 2406, JeffMcLaughlin, +1 215 751 7002