What was the difference between individuals with Human Immunodeficiency Virus (HIV) who took Antiretroviral Therapy (ART) versus those who did not take ART before the Nigella sativa study?

From the Guidelines

The main difference between HIV patients taking antiretroviral therapy (ART) and those not taking ART before the Nigella sativa study was their overall health status and viral load, with ART patients typically having better outcomes in terms of morbidity, mortality, and quality of life. Patients on ART typically had:

• Lower HIV viral loads
• Higher CD4 T-cell counts
• Better overall immune function
• Fewer opportunistic infections
• Improved quality of life Those not on ART generally had:
• Higher viral loads
• Lower CD4 T-cell counts
• More compromised immune systems
• Greater risk of opportunistic infections
• Poorer overall health outcomes As stated in the 2018 recommendations of the International Antiviral Society-USA panel 1, ART is recommended for virtually all HIV-infected individuals, as soon as possible after HIV diagnosis, highlighting its crucial role in managing the disease. The use of ART has been shown to suppress HIV replication, allowing the immune system to recover and maintain better function, which leads to significant improvements in health and longevity for most patients 1. Therefore, ART should be the primary treatment approach for HIV patients, and any complementary therapies, such as Nigella sativa, should be used in conjunction with, not in place of, standard ART.

From the FDA Drug Label

The difference in the proportion of subjects who achieved and maintained HIV-1 RNA <400 copies/mL through 48 weeks largely results from the higher number of discontinuations due to adverse events and other reasons in the AZT/3TC group in this open-label trial

The difference between individuals with Human Immunodeficiency Virus (HIV) who took Antiretroviral Therapy (ART) versus those who did not take ART before the study is not directly addressed in the provided text. However, the text does describe the outcomes of clinical trials comparing different ART regimens.

• Key points:
  • The clinical trials compared the efficacy and safety of emtricitabine versus other antiretroviral therapies in treatment-naïve and treatment-experienced adults.
  • The trials showed that emtricitabine-based regimens were effective in achieving and maintaining HIV-1 RNA <400 copies/mL and <50 copies/mL.
  • The mean increase from baseline in CD4+ cell count was higher in the emtricitabine groups compared to the comparator groups.
  • The trials did not directly compare individuals who took ART versus those who did not take ART before the study. 2

From the Research

Differences Between Individuals with HIV Who Took ART and Those Who Did Not

• The studies 3, 4, 5 compared the outcomes of individuals with HIV who initiated Antiretroviral Therapy (ART) with those who did not.
• Individuals who took ART had higher rates of retention in HIV care and viral suppression at 48 weeks, and lower mortality rates 3.
• Early initiation of ART was associated with a lower probability of clinical progression to more advanced CDC stages and significant immunological benefits, including higher CD4+ T cell counts and lower viral loads 4.
• ART initiation within 6 months of HIV infection was associated with lower T-cell activation and smaller HIV reservoir size 5.
• In contrast, individuals who did not take ART had lower CD4+ T cell counts, higher viral loads, and a higher probability of clinical progression to more advanced CDC stages 4.

Outcomes of Early ART Initiation

• Early ART initiation was associated with rapid virological control, with 85.2% of individuals achieving an undetectable viral load (<50 copies/mL) at 48 weeks 3.
• Individuals who initiated ART early had higher CD4+ T cell counts and lower viral loads at 12 and 24 months after diagnosis 4.
• Early ART initiation was also associated with lower T-cell activation and smaller HIV reservoir size, which may predict better long-term outcomes 5.

Challenges of ART

• The requirement for lifelong ART poses multiple challenges for individuals with HIV, including stigma, pill burden, side effects, and the threat of viral resistance in the case of non-compliance 6.
• Treatment interruption has been explored as a strategy to minimize adverse effects of ART and to test interventions aiming to achieve a degree of virological control without ART 7.