Advances In Vaccine And Treatment Research Open New Doors In The Fight Against HIV

Researchers announced encouraging developments across several critical areas of HIV research at an official press conference at the 9th IAS Conference on HIV Science (IAS 2017).

These included a promising vaccine candidate, positive results for an innovative HIV treatment option and better strategies to combat co-infections. The briefing also featured the results of a rigorous new survey in Swaziland -- which has the world's highest HIV prevalence -- showing the extraordinary national impact of expanded HIV prevention and treatment efforts.

"Each of the studies we are highlighting today takes us one step closer to the end of HIV," Linda-Gail Bekker, the International AIDS Society (IAS) President and International Scientific Chair of IAS 2017, said. "This research moves us forward on many fronts, from vaccines to new treatment approaches, to real-world evidence that our current efforts to expand testing and treatment are paying off."

The press briefing highlighted five studies, which were selected from more than 1,700 scientific abstracts being presented at IAS 2017.

Promising HIV vaccine regimen cleared for new efficacy study:
Results from APPROACH, a Phase 1/2a study evaluating seven different "prime boost" HIV vaccine regimens, identified a promising vaccine candidate that will be evaluated in a proof-of-concept efficacy study among those at risk for HIV. The APPROACH study included 393 low-risk, HIV-negative adults in the United States, Rwanda, Uganda, South Africa and Thailand.

Dan Barouch of Harvard Medical School reported the APPROACH study results, which found that the vaccine regimen encompassing two primes with Ad26.Mos.HIV and two boosts with Ad26.Mos.HIV and aluminum-adjuvanted Clade C gp140 achieved the strongest immunological response. This same regimen also provided the greatest protection in earlier non-human primate studies. The proof-of-concept study could start by the end of 2017. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: Selection of a lead HIV-1 vaccine regimen in APPROACH, a Phase 1/2a study evaluating seven heterologous prime boost regimens using mosaic Ad26 and -MVA vectors combined with soluble Env protein
Session: Translational Vaccinology Symposium (Room 251; Monday, 24 July, 11:00-12:30)

Simpler treatment identified for HIV-associated cryptococcal meningitis, which kills more than 100,000 people each year:
The current "gold standard" treatment for cryptococcal meningitis is amphotericin plus flucytosine for two weeks, but this regimen is often unavailable in low-income countries. Sile Molloy of St George's, University of London presented results from the ACTA Trial, which explored two new strategies that could be both sustainable in Africa and more effective than fluconazole, which is most commonly used in resource-limited settings: short (one week) induction with amphotericin-based treatment, and oral therapy of high-dose fluconazole plus flucytosine.

The trial enrolled 721 participants with first-episode cryptococcol meningitis in Malawi, Zambia, Cameroon, and Tanzania. In the amphotericin arms, researchers compared fluconazole and flucytosine as adjunctive treatments and found that flucytosine was superior. Study results showed that one week of amphotericin plus flucytosine and two weeks of the oral combination of fluconazole plus flucytosine both provided safe, effective and sustainable induction therapy.

Researchers concluded that flucytosine should be made widely available in resource-limited settings for the treatment of cryptococcosis. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: A randomized controlled trial for the treatment of HIV-associated cryptococcal meningitis in Africa: oral fluconazole plus flucytosine or one-week amphotericin-based therapy vs two weeks amphotericin-based therapy. The ACTA Trial
Session: Co-Chairs' Choice (Blue Amphitheatre; Monday, 24 July, 11:00-12:30)Researchers announced encouraging developments across several critical areas of HIV research at an official press conference at the 9th IAS Conference on HIV Science (IAS 2017).

These included a promising vaccine candidate, positive results for an innovative HIV treatment option and better strategies to combat co-infections. The briefing also featured the results of a rigorous new survey in Swaziland -- which has the world's highest HIV prevalence -- showing the extraordinary national impact of expanded HIV prevention and treatment efforts.

"Each of the studies we are highlighting today takes us one step closer to the end of HIV," Linda-Gail Bekker, the International AIDS Society (IAS) President and International Scientific Chair of IAS 2017, said. "This research moves us forward on many fronts, from vaccines to new treatment approaches, to real-world evidence that our current efforts to expand testing and treatment are paying off."

The press briefing highlighted five studies, which were selected from more than 1,700 scientific abstracts being presented at IAS 2017.

Promising HIV vaccine regimen cleared for new efficacy study:
Results from APPROACH, a Phase 1/2a study evaluating seven different "prime boost" HIV vaccine regimens, identified a promising vaccine candidate that will be evaluated in a proof-of-concept efficacy study among those at risk for HIV. The APPROACH study included 393 low-risk, HIV-negative adults in the United States, Rwanda, Uganda, South Africa and Thailand.

Dan Barouch of Harvard Medical School reported the APPROACH study results, which found that the vaccine regimen encompassing two primes with Ad26.Mos.HIV and two boosts with Ad26.Mos.HIV and aluminum-adjuvanted Clade C gp140 achieved the strongest immunological response. This same regimen also provided the greatest protection in earlier non-human primate studies. The proof-of-concept study could start by the end of 2017. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: Selection of a lead HIV-1 vaccine regimen in APPROACH, a Phase 1/2a study evaluating seven heterologous prime boost regimens using mosaic Ad26 and -MVA vectors combined with soluble Env protein
Session: Translational Vaccinology Symposium (Room 251; Monday, 24 July, 11:00-12:30)

Simpler treatment identified for HIV-associated cryptococcal meningitis, which kills more than 100,000 people each year:
The current "gold standard" treatment for cryptococcal meningitis is amphotericin plus flucytosine for two weeks, but this regimen is often unavailable in low-income countries. Sile Molloy of St George's, University of London presented results from the ACTA Trial, which explored two new strategies that could be both sustainable in Africa and more effective than fluconazole, which is most commonly used in resource-limited settings: short (one week) induction with amphotericin-based treatment, and oral therapy of high-dose fluconazole plus flucytosine.

The trial enrolled 721 participants with first-episode cryptococcol meningitis in Malawi, Zambia, Cameroon, and Tanzania. In the amphotericin arms, researchers compared fluconazole and flucytosine as adjunctive treatments and found that flucytosine was superior. Study results showed that one week of amphotericin plus flucytosine and two weeks of the oral combination of fluconazole plus flucytosine both provided safe, effective and sustainable induction therapy.

Researchers concluded that flucytosine should be made widely available in resource-limited settings for the treatment of cryptococcosis. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: A randomized controlled trial for the treatment of HIV-associated cryptococcal meningitis in Africa: oral fluconazole plus flucytosine or one-week amphotericin-based therapy vs two weeks amphotericin-based therapy. The ACTA Trial
Session: Co-Chairs' Choice (Blue Amphitheatre; Monday, 24 July, 11:00-12:30)

Progress in developing a long-acting injectable HIV treatment:
LATTE-2 is a Phase IIb open-label study of a long-acting, injectable, two-drug therapy with cabotegravir (an integrase inhibitor) and rilpivirine (a second-generation NNRTI) as a maintenance therapy for people who have already achieved viral suppression. Studies show that some people living with HIV would find long-acting injectable treatment to be more convenient or less stigmatizing than daily oral pills, which could help improve treatment adherence rates.

Joseph Eron of the University of North Carolina at Chapel Hill presented 96-week LATTE-2 results, which found that patients receiving the long-acting injectable tolerated it well and achieved high rates of virologic response, regardless of whether the injections were once every four weeks or once every eight weeks. The four-week dosing schedule is now being evaluated in Phase III studies. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: Safety and efficacy of long-acting CAB and RPV as two drug IM maintenance therapy: LATTE-2 week 96 results
Session: Co-Chairs' Choice (Blue Amphitheatre; Monday, 24 July, 11:00-12:30)

Remarkable nationwide impact of expanded HIV prevention and treatment in Swaziland:
Overall HIV incidence in Swaziland dropped by almost half (46%) from 2011 to 2016 as the country scaled up a comprehensive, national HIV prevention and treatment programme. This is according to a rigorous survey intended to directly measure the impact of the programme. It also found that the proportion of people living with HIV who have achieved viral suppression doubled (from 35% to 73%).

Known as a population-based HIV impact assessment (PHIA), this is a nationally representative survey that includes HIV and viral load testing. According to presenter Velephi Okello of the Swaziland Ministry of Health, these findings provide the first direct evidence of the national impact of expanded HIV treatment programmes on HIV incidence in a high-prevalence country. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: Substantial progress in confronting the HIV epidemic in Swaziland: first evidence of national impact
Session: Co-Chairs' Choice (Blue Amphitheatre; Monday, 24 July, 11:00-12:30)

Hepatitis C treatment is feasible, effective and safe in sub-Saharan Africa:
The advent of highly effective antiviral drugs has made hepatitis C virus (HCV) elimination possible, but these treatments remain largely out of reach in sub-Saharan Africa.

TAC ANRS 12311 is an open-label trial assessing the feasibility, efficacy and safety of treating HCV-infected patients in sub-Saharan Africa with interferon-free, direct-acting antiviral therapies. The trial included 120 participants with treatment-na�ve chronic hepatitis C in Senegal, C�te d'Ivoire and Cameroon; 32 participants were co-infected with HIV. Patients without decompensated cirrhosis received a 12-week combination of sofosbuvir plus weight-based ribavirin (if infected with genotype 2) or sofosbuvir/ledipasvir (if infected with genotypes 1 or 4).

Karine Lacombe of Saint-Antoine Hospital and Inserm in Paris reported the trial's results. Based on outcomes in the first 110 participants, HCV treatment appeared to be feasible, effective and safe in sub-Saharan Africa, including in HIV co-infected patients. Study authors conclude that, given the growing availability of drugs at generic prices, it is time to scale up HCV care and management in Africa. [Summary based on submitted abstract; updated data may be presented on site.]

Abstract: Treatment of chronic hepatitis C genotype 1, 2 and 4 in patients with or without HIV and living in Central or West Africa: the TAC ANRS 12311 trial
Session: Co-Chairs' Choice (Blue Amphitheatre; Monday, 24 July, 11:00-12:30)