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ViiV Healthcare welcomes the FDA’s Tentative Approval of the first generic dolutegravir from Aurobindo Pharma
ViiV Healthcare welcomes today’s decision by the US Food and Drug Administration (FDA) to grant Aurobindo Pharma Tentative Approval for the first generic version of dolutegravir 50mg for the treatment of HIV in the developing world.
“We think that this Tentative Approval of the first generic dolutegravir from Aurobindo will improve access to dolutegravir in the developing world for those patients in need,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare. “It is great to see our access strategy deliver progress in bringing recently approved ARVs like dolutegravir to patients in countries where the burden of HIV is greatest in a timely manner, in this case just over three years since it was first made available in the Unites States and just under three years since it was first made available in Europe.”
The approval is a prerequisite for Aurobindo's product to be supplied under the President's Emergency Plan for Aids Relief (PEPFAR) programme. The submission was supported by ViiV Healthcare and the Clinton Access Initiative (CHAI), in accordance with their agreement to support the development and introduction of innovative formulations of medicines to treat people living with HIV in developing countries on an affordable yet sustainable basis.
Globally, there are more than 36 million people living with HIV. Scaling-up HIV treatment in low- and middle-income countries over the past 15 years is one of the greatest success stories in global health and ensuring that all people living with HIV have access to HIV medicines is a crucial part of the global response to the epidemic.
Dolutegravir 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 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 chronic infection. Dolutegravir is currently recommended by the World Health Organisation (WHO) as an alternative first-line therapy for the treatment of HIV in adults and adolescents 12 years and older.
Professional Indication(s) and Important Safety Information about TIVICAY® (dolutegravir) tablets:
Note: this is taken from the US label and local variations apply. Please refer to applicable local labelling
FDA Indications and Usage
TIVICAY® is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.
Limitations of Use:
Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R
Important Safety Information
TIVICAY is contraindicated in patients:
- with previous hypersensitivity reaction to dolutegravir
- receiving dofetilide (antiarrhythmic)
- Hypersensitivity reactions have been reported and were characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in Phase 3 clinical trials
- Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:
- Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
- Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C
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 (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).
- 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.
 UNAIDS Factsheet. July 2016.Available at: http://www.unaids.org/en/resources/fact-sheet. Last accessed July 2016.
 UNAIDS. How AIDS Changed Everything. Available at: http://www.unaids.org/sites/default/files/media_asset/MDG6Report_en.pdf. Last accessed: September 2016.
 WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Available at: http://www.who.int/hiv/pub/arv/arv-2016/en/. Last accessed: July 2016.