Introduction

The National AIDS Control Organization (NACO) recommends Dolutegravir (DTG) as the preferred treatment for individuals living with HIV, given its effectiveness against both HIV types 1 and 2. DTG works by inhibiting integrase activity, thereby blocking HIV replication, and is suitable for both first-line and second-line treatment regimens.

Aim 

To examine the clinical profile of HIV-positive individuals receiving DTG and assess the AEs associated with DTG usage.

Patient Profile

Patients aged >18 years receiving the DTG regimen

Method

• A prospective observational study conducted at the ART center of King Edward Memorial Hospital, a tertiary care facility located in India.
• N= 319 participants
• HIV-positive patients receiving DTG-based ART regimens were studied. 
• Key parameters assessed included treatment adherence, and CD4 count. 
• Patients were monitored for six months to track the occurrence of comorbidities and adverse events (AEs).

Result

• In the study, 31.0% of subjects had a history of or current tuberculosis (TB), 24.1% were hypertensive, and 13.2% had diabetes mellitus (DM). Additionally, 1.9% had bronchial asthma, while both thyroid disorders and ischemic heart disease (IHD) were present in 1.3% of subjects each.
• There was an increase in mean CD4 count in PLHIV after receiving DTG based regimen, p=0.0392.
•  A portion of participants encountered AEs associated with prolonged ART usage.
• However, no patient required drug discontinuation due to DTG-related adverse events.

Figure 1: Clinical features of patients before receiving DTG & six months after DTG

• Neuropsychiatric symptoms (headaches and mood fluctuations)
  1. 3.1%  patients had headaches
  2. 0.84% patients had mood disturbances
  3. New-onset mood disturbances were reported in 0.94% study subjects receiving DTG
• Adverse Events Distribution 
  1. The most common drug-related ADEs among patients receiving DTG were weight gain, elevated liver function, hyperlipidemia & hyperglycemia
  2. 26.95% of study subjects had weight gain
  3. The average weight gain over six months was 4.01 kg
  4. 15 % of study subjects exhibited elevated liver enzymes 
  5. Among those with LFT abnormalities, 77.02% experienced a self-resolution to normal levels without intervention, while 22.98% continued to have deranged LFTs

Table 1 : Proportion of patients experiencing ADEs  after receiving DTG

Conclusion

• DTG is well-tolerated by HIV patients, which improves adherence to ART and boosts immune function.
• Common ADEs linked to DTG include weight gain, hyperlipidemia, hyperglycemia, and liver enzyme abnormalities, along with some neuropsychiatric symptoms. All ADEs were manageable and not life-threatening.
• It is advised that individuals with HIV undergo screening and treatment for non-communicable diseases like diabetes mellitus and hypertension, as well as communicable diseases such as TB.

Reference 

Cureus.2024.16;6: e62522