Lauren Santye, Assistant Editor

	Beth Wallace provides advice to patients with leiomyosarcoma, as well as to women with cancer in general.

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Cancer patient Beth Wallace provides advice to patients with leiomyosarcoma, as well as to women with cancer in general. 

What Advice Would You Give to Patients?

A fixed-dose combination of bictegravir and emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was non-inferior to boosted protease inhibitor (bPI)-based regimens in virologically suppressed adults with HIV, according to a recently-published phase 3 study. 

Included in the phase 3 study 1878 were 577 virologically-suppressed adults with HIV who were receiving boosted atazanavir (ATV) or darunavir (DRV) plus abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF), according to a press release.

The participants were randomized 1:1 to either continue their bPI regimen or switch to open-label co-formulated BIC/FTC/TAF once daily. At week 48, switching to BIC/FTC/TAF was found to be non-inferior to continuing bPI treatment, with 1.7% of patients in each arm having HIV-1 RNA ≥50 c/mL.

There were 92.1% of patients in the BIC/FTC/TAF arm who had HIV-1 RNA ≥50 c/mL, and 88.9% in the bPI arm, according to the release.

“These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs,” said lead author Eric Daar, MD, in the release. “The findings, along with data from 3 other phase 3 studies in both treatment-experienced and treatment-naïve patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.”

There were no reports of patients in the BIC/FTC/TAF arm developing treatment-emergent resistance. Only 1 participant on DRV/ritonavir plus ABC/3TC developed a treatment-emergent NRTI mutation associated with abacavir.

In the BIC/FTC/TAF arm, there were no reports of renal adverse events (AEs) leading to discontinuations or cases of proximal renal tubulopathy. The incidence of grade 3 or 4 AEs were 4% in the BIC/FTC/TAF arm compared with 6% in the bPI arm, according to the report. Incidence of grade 3 or 4 laboratory abnormalities were 6% for the BIC/FTC/TAF arm versus 29% for the bPI arm.

The most common AEs in both arms were headache, diarrhea, nasopharyngitis, and upper respiratory tract infection.

“The combination of unboosted integrase inhibitor with the FTC/TAF backbone has the potential to further evolve HIV triple therapy with convenient dosing in a single-tablet regimen,” Norbert W. Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead, said in the release. “We look forward to the opportunity to offer patients this next-generation therapy as part of our TAF-based portfolio of treatments for HIV.”

A New Drug Application for BIC/FTC/TAF was filed on June 12, 2017, and the treatment was granted Priority Review. The FDA set a target action date of February 12, 2018. Additionally, a marketing application for BIC/FTC/TAF is under review in the European Union and was validated by the European Medicines Agency on July 13, 2017, according to the release. 

Articles

Bictegravir Combo Treatment Non-inferior to Boosted Protease Inhibitors in HIV?

Achieving National HIV/AIDS Strategy (NHAS) target goals could prevent an estimated 200,000 deaths over 20 years, according to a study recently published in the 

The primary goals of the NHAS are for 90% of HIV-positive individuals to know their diagnosis, and for 80% of those patients to achieve virologic suppression via antiretroviral therapy (ART) by 2020.

In the study, Massachusetts General Hospital (MGH) analysts found that meeting the goals of NHAS would save more than 2 million years of life over the next 2 decades.

“If nearly everyone with HIV in the US were in care, on medication, and virally suppressed, we would stop the epidemic in its tracks,” said senior author Rochelle P. Walensky, MD, MPH, chief of the MGH Division of Infectious Diseases. “Achieving the NHAS goals would bring us one step closer to that goal.”

The NHAS was released in 2015 to better align US HIV/AIDS policies with the Joint United Nations Programme on HIV/AIDS 90-90-90 target, which states that by 2020, 90% of all individuals living with HIV will know their status, 90% of HIV-positive individuals will receive sustained ART, and 90% of all individuals receiving ART will achieve viral suppression.

If the NHAS targets are met, 72% of HIV-positive individuals would successfully achieve virologic suppression compared with current estimates of 49%.

An estimated 1.1 million individuals in the United States are living with HIV, and 1 of every 7 are unaware of their status. According to the CDC, men who have sex with men (MSM) and bisexual men are most affected, particularly African Americans.

For the study, MGH investigators sought to identify the expected return on investment for the programs required to achieve NHAS goals, and to highlight the impact that failing to achieve the goals would have on illness and death. A separate analysis was conducted on the impact of NHAS among black MSM.

The investigators used a mathematical model to assess the cost efficacy of HIV/AIDS prevention, and compared the forecasted results of continuing at the current pace of HIV diagnosis, linkage to and retention in treatment, and viral suppression to achieving NHAS goals. They projected both the clinical benefits and costs over a 20-year period.

The findings showed that if the United States remained at its current pace, then 750,000 deaths from HIV/AIDS would occur over 20 years. Contrastingly, if NHAS goals were achieved, it would reduce total deaths to 551,000, preventing approximately 200,000 deaths.

Among the black MSM patient population, achieving NHAS targets would reduce the number of deaths from 110,000 to 65,000.

“Achieving NHAS goals is entirely feasible,” said co-author Kenneth Freedberg, MD, MSc. “One of the biggest barriers is retaining patients in care, but our projections would be enough to reach these goals. This study is only the latest contribution to the large evidence base demonstrating conclusively that we have it in our clinical and economic power to bring the HIV/AIDS epidemic in the US to a halt. Now is the time to do so.”

Over the next 20 years, meeting NHAS targets would cost an estimated $645.7 billion compared with $525.3 billion under the current pace; however, the number of lives saved would result in a cost effectiveness ratio of $68,900 per quality-adjusted life year (QALY). According to the authors, this is well within the US cost effectiveness standard of 100,000/QALY.

Findings from the separate analysis of the black MSM population revealed that achieving the NHAS targets would produce a ratio of $38,300/QALY.

The authors noted that reducing the cost of ART could lead to even greater cost effectiveness because almost 75% of costs are attributable to ART.

“Achieving NHAS won’t be cheap, but it would be affordable and cost effective,” Freedberg said. “It would make good public health and economic sense to first focus NHAS implementation on black MSM, since they are at considerably higher risk than the general population. Overall, fully implementing NHAS could avert more than 200,000 deaths and prevent more than 250,000 HIV infections over the next 20 years.”

Achieving National HIV/AIDs target goal could prevent an estimated 200,000 deaths over 20 years, according to a study recently published in the Journal of Infectious Diseases. 

Meeting National HIV/AIDS Strategy Goals Could Save 200k Lives

	Beth Wallace was always one to advocate for herself in different areas of her life, but when it came to her health, she left it to the doctors. Here, she discusses the importance of education and being your own advocate. 