As another HIV Vaccine Awareness Day slides by on the calendar, there is still no cure for the disease. However, many pharma and biotech companies are desperately working on developing therapeutics for the devastating disease.
As another HIV Vaccine Awareness Day slides by on the calendar, there is still no cure for the disease. However, many pharma and biotech companies are desperately working on developing therapeutics for the devastating disease.
On May 18 the world observed HIV Vaccine Awareness Day as a day to acknowledge those who are working together to find an effective vaccine to prevent HIV. To note the day, BioSpace took a look at some key events this year in the battle against HIV.
This year new hope may have been injected into the fight against AIDS. First Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, predicted the AIDs epidemic can be defeated within the next three to seven years. The other key event was preclinical research conducted by Gilead. In preclinical models, a two-drug combination appeared to eliminate the disease from an infected monkey, which means Gilead could be on its way to actually finding an effective cure for the disease – if the research holds through human trials.
Data from CDC shows there were an estimated 37,600 new HIV infections in the United States in 2014, the most recent year for which the agency provides data. The CDC noted that annual infection and diagnosis rates in the U.S. have been declining, but added the caveat that progress has been uneven and infections have risen among some groups in the population. Currently, there are numerous HIV therapeutics in clinical trials across the globes, but since the beginning of 2018, the U.S. Food and Drug Administration has approved three new therapies for HIV patients.
In February the FDA gave its approval to Gilead Sciences Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 in adults who haven’t been treated with antiretrovirals. The drug was also green lit for to replace the current antiretroviral regimen in patients who have been virologically suppressed on a stable antiretroviral regimen for at least three months. Gilead’s HIV cocktail combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone. Gilead’s Biktarvy comes with a black-box warning that use of the drug could exacerbate hepatitis B. Despite that, analysts predict the medication will hit blockbuster status due to the wide number of patients who can benefit from the combination treatment.
In March the FDA approved Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1. Developed by Theratechnologies Inc. and TaiMed Biologics, Trogarzo is designed in part to provide greater quality of life to patients because the drug is the only antiretroviral medicine that does not require daily dosing. Trogarzo is administered intravenously once every 14 days. It is being used in combination with other antiretroviral treatments. Trogarzo is a CD4-directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells. The approval of Trogarzo provides a new treatment for about 25,000 HIV patients who are classified as multi-drug resistant.
Alongside the team up of Theratechnologies and TaiMed Biologics, Mylan also snagged approval for its HIV treatment Symfi in March. Mylan’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) was approved for adult and pediatric HIV-1 patients who weigh at least 40 kilograms. That FDA nod was the third the company earned for its HIV treatments. The other two approved Mylan HIV drugs are Cimduo (lamivudine and tenofovir disoproxil fumarate) and Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate), which became available to U.S. patients in March.
In November 2017 the FDA approved Juluca, the combination treatment developed by GlaxoSmithKline’s subsidiary ViiV Healthcare and Janssen Pharmaceuticals. Juluca combines ViiV’s dolutegravir, an integrase strand transfer inhibitor and Janssen’s rilpivirine, a non-nucleoside reverse transcriptase inhibitor. The use of a two-drug regimen is something that many healthcare experts believe could reduce toxicity in patients. Juluca, which will be marketed in the United States as Edurant by Janssen, will be used to treat HIV-1, the same indication that Gilead won approval for with Biktarvy.
As mentioned before, there are still a number of HIV treatments in clinical trials as well. Merck is eying an Oct, 28 PDUFA date for its drug doravirine, a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI). Trial data at 48 weeks shows doravirine, is slightly more effective than the commonly used drug Atripla, which is a triple cocktail of efavirenz (EFV), emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) in treatment-naïve adults infected with HIV-1.
In April SignalRX Pharmaceuticals Inc. announced its dual PI3K/BRD4 inhibitor SF2523 suppresses HIV-1 replication and eliminates the latent infectious state.
