Drug reducing risk of HIV transmission in healthy people okayed

The approval makes Israel one of the first countries to implement it.

Teva Pharmaceutical Industries building in Jerusalem. (photo credit: MARC ISRAEL SELLEM/THE JERUSALEM POST)
Teva Pharmaceutical Industries building in Jerusalem.
A drug named Truvada that can reduce the risk of contracting HIV from sexual contact by more than 90%, and by more than 70% for people who inject drugs, has been approved by the Health Ministry for marketing in Israel.
The official approval was followed by the preparation of a one-day risk management program to train doctors who will prescribe the drug, mostly to healthy men who have sex with men, but also to women who are partners with HIV-infected men.
The pharmaceutical companies that make the drug, Teva and Gilead, will apply for its inclusion in the 2018 medications basket via approval by the public committee that meets at the end of this year.
Prof. Eyal Schwartzberg, head of the ministry’s center for pharmaceuticals and enforcement, told The Jerusalem Post on Sunday that the drug is taken orally once a day by a person who is in a sexual relationship with an HIV carrier or AIDS patient. Truvada is meant for pre-exposure prophylaxis for healthy people at very high risk for HIV, especially those whose partners are infected.
The medication interferes with HIV’s ability to copy itself in the body after exposure to the virus.
This prevents it from establishing an infection and making the host sick.
Truvada is regarded as highly effective in preventing HIV if used as prescribed, but it is much less effective if not taken on a daily basis. Among people who inject drugs, the risk of getting HIV from sex can be even lower if the patient combines pre-exposure use with condoms and other disease-prevention methods.
The medication, which combines the antiviral drugs emtricitabine and tenofovir disoproxil fumarate, is not a cure for HIV or AIDS. Its use has been endorsed by the US Centers for Disease Control and the World Health Organization.
The approval makes Israel one of the first countries to implement it.
San Francisco, which has an HIV rate similar to that in Israel, is one of the few places in the world that already has a prevention program which includes the drug that lowers the infection risk close to zero. The medication has already been included in the French health basket, and is due to be introduced in several US states.
The drug is already being taken by numerous Israelis who have purchased it via the Internet and managed to pick it up by mail or by smuggling it in, Schwartzberg said.
Thus a risk-management program supervising legal use was vital.
The drugs are to be provided at AIDS centers in hospitals and clinics that serve homosexuals, in addition to health fund clinics. Those who take the drug have to be under a doctor’s supervision, because it can cause serious complications in a minority of patients. These include kidney failure, too much lactic acid in the blood, or lactic acidosis, which is a serious medical emergency. It can also result in serious liver problems, the worsening of hepatitis B infection and bone problems. The most common side effects of Truvada include diarrhea, nausea, tiredness, headache, dizziness, depression, sleeping problems and rash.
The Israel AIDS Task Force congratulated the ministry on approving the sale of the drug and preparing a risk-management program.
“It is a revolution for thousands of Israelis in high-risk groups for contracting HIV,” said task force director Dr. Yuval Livnat.
Yesh Atid MK Yael German, who took credit for the process of approval when she was health minister, said she welcomed the ministry’s action. “The next step is to include it in the basket of medical technologies,” she said.