DCGI approves new drug for HIV control
Chennai: The Drug Controller General of India has approved TLE400 (Tenofovir Disoproxil Fumarate 300 mg/Lamivudine 300mg/ Efavirenz 400 mg) as an alternative first-line treatment drug for HIV-infected people. Efavirenz (600mg), a drug used for first-line-treatment and control of HIV, was found to have certain side effects on infected people.
In India, Tamil Nadu with 1.43 lakh People Living with HIV (PLHIV) in the state has a higher prevalence of 0.26 percent than the national average of the HIV infected population. One of the biggest challenges faced by doctors and healthcare provider is the non-adherence of HIV medication prescribed to infected patients.
Intolerable side effects and the high cost of available drugs are important factors contributing to non-adherence. Annual Report of National AIDS Control Programme (NACO) highlighted that non-adherence to treatment in HIV leads to drug resistance and treatment failure.
Doctors are positive that new drug with reduced side effects will improve treatment adherence.
The new ARV drug, TLE400 shows same efficacy as that of those with 600 mg Efavirenz. As the new drug has been launched at lower prices than other first-line ARV drugs, fight against HIV epidemic seems to be growing stronger.
Explaining the effects of Efavirenz on the human body, “People taking Efavirenz for first-line ART regimen for reducing viral load against HIV for the first time suffered multiple side-effects, such as depression, dizziness, skin rashes, fatigue, dyslipidemia, nausea, vomiting, and anorexia, among others,” said senior pharmacologist, Dr A. Sharmila. The side effects are dose–dependent to an extent. The standard dosage of 600 mg of Efavirenz has reportedly caused these central nervous system side.