🗞️ Why in News Zimbabwe became one of the first countries to launch a nationwide rollout of Lenacapavir (brand name: Yeztugo), developed by Gilead Sciences — the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention, approved after landmark PURPOSE 1 and PURPOSE 2 clinical trials showed ~99.9% effectiveness.

What Is PrEP and Why It Matters

PrEP (Pre-Exposure Prophylaxis) is a prevention strategy where HIV-negative individuals take antiretroviral medicine to significantly reduce the risk of contracting HIV. It is not a vaccine — it does not generate immunity — but it prevents the virus from establishing a permanent infection if exposure occurs.

Existing oral PrEP (Truvada/Generic): A daily pill combining tenofovir and emtricitabine. Extremely effective (>99% when taken daily) but requires:

  • Daily adherence — missing doses reduces protection
  • Regular clinic visits for HIV testing and prescription renewal
  • Stigma management — carrying/taking daily pills in high-stigma environments

The adherence problem is the central challenge in HIV prevention. Studies consistently show that people most at risk — young women in sub-Saharan Africa, sex workers, people who inject drugs — have the hardest time maintaining daily pill regimens due to stigma, irregular access to healthcare, and life circumstances.

Lenacapavir: The Science

Lenacapavir (brand: Yeztugo) is a novel capsid inhibitor developed by Gilead Sciences (USA).

Mechanism of Action

HIV uses a capsid protein to protect its genetic material and control replication inside host cells. Lenacapavir targets and disrupts the capsid protein at multiple stages of the viral replication cycle — preventing viral assembly, transport, and integration into the host cell’s DNA.

This multi-stage mechanism is why it is:

  1. Highly potent at low doses — less drug needed
  2. Long-acting — a single subcutaneous injection provides protective drug levels for 6 months
  3. Effective against drug-resistant HIV strains that have developed resistance to other antiretrovirals

Administration

  • Subcutaneous injection (just under the skin, typically in the abdomen)
  • Twice yearly (every 26 weeks)
  • Administered by a healthcare worker

Clinical Trials: PURPOSE 1 and PURPOSE 2

Two landmark Phase 3 trials demonstrated Lenacapavir’s efficacy for PrEP:

PURPOSE 1 (Africa — cisgender women and adolescent girls):

  • 5,338 participants across Uganda and South Africa
  • Zero HIV infections in the Lenacapavir arm vs. 16 in the daily oral TDF/FTC (tenofovir/emtricitabine) arm
  • 100% efficacy in the initial trial data (later revised to ~99.9%)

PURPOSE 2 (Global — cisgender men, transgender women/men):

  • Confirmed efficacy across diverse populations
  • 96% reduction in HIV infections compared to daily oral PrEP

Zimbabwe: The Context

Zimbabwe has one of the world’s highest HIV burden:

  • HIV prevalence: ~11.9% of adults aged 15–49
  • People living with HIV: ~1.3 million
  • New infections annually: ~33,000
  • Most at-risk group: Young women aged 15–24 (prevalence 3× higher than young men)

The Lenacapavir rollout specifically targets:

  • Women and girls aged 16–25 — most biologically vulnerable to HIV (cervical tissue susceptibility + power imbalances in sexual relationships)
  • Health workers in high-burden settings
  • Others at substantial risk

Zimbabwe’s national rollout makes it one of the first countries to implement the injection at scale after WHO prequalification.

India’s Role in Global HIV Medicine

India’s pharmaceutical industry is central to global HIV treatment access:

  • Generic ARVs (antiretrovirals) manufactured by Indian firms — primarily CIPLA, Sun Pharma, Aurobindo — supply approximately 80% of HIV treatment in low-income countries
  • CIPLA’s 2001 decision to offer a triple ARV combination for $1/day (vs. $10,000+/year from Western firms) transformed global HIV treatment access
  • Generic lenacapavir: Gilead has licensed generic manufacturing rights to several companies including Indian firms — generic versions are expected to bring the cost from ~$40,000/year (US price) to under $100/year for low-income countries

PEPFAR (President’s Emergency Plan for AIDS Relief) — the US programme launched in 2003 — funds HIV treatment in Africa and is a major purchaser of Indian-manufactured generics.

Medicines Patent Pool (MPP): A UN-backed body that negotiates voluntary licences with innovator companies (like Gilead) to allow generic manufacturers to produce affordable versions for low-income countries. Gilead has signed an MPP licence for Lenacapavir — covering 120+ countries including most of Africa.

Global HIV Statistics

Indicator Data
People living with HIV globally ~39 million
New HIV infections per year ~1.3 million
AIDS-related deaths per year ~630,000
People on antiretroviral treatment ~30 million
Progress toward 95-95-95 targets 86-89-93% globally (2023)

UNAIDS 95-95-95 targets (by 2025):

  • 95% of HIV+ people know their status
  • 95% of diagnosed people on treatment
  • 95% of treated people virally suppressed (undetectable = untransmittable)

UPSC Relevance

Prelims: Lenacapavir, Yeztugo, Gilead Sciences, capsid inhibitor, PrEP, PURPOSE 1 and 2, PEPFAR, MPP, UNAIDS, 95-95-95 targets, CIPLA, Zimbabwe. Mains GS-2: India’s role in global health; access to medicines and TRIPS flexibilities; PEPFAR and global health financing. GS-3: Pharmaceutical industry; generic drugs; IPR and public health. Interview: “Should India’s generic drug manufacturing be considered a form of soft power or health diplomacy?”

📌 Facts Corner — Knowledgepedia

Lenacapavir — Core Data:

  • Brand name: Yeztugo | Developer: Gilead Sciences (USA)
  • Drug class: Capsid inhibitor (novel mechanism; first in class)
  • Route: Subcutaneous injection, twice yearly (every 26 weeks)
  • Indication: PrEP (HIV prevention in HIV-negative people)
  • Efficacy: ~99.9% HIV prevention (PURPOSE 1 trial: 100% initially)
  • Approval: WHO prequalified; FDA approved 2024 for PrEP

PURPOSE Trials:

  • PURPOSE 1: Africa (Uganda + South Africa); cisgender women + adolescent girls; 5,338 participants
  • PURPOSE 2: Global; cisgender men, transgender women/men
  • Comparator: Daily oral TDF/FTC (tenofovir/emtricitabine)

Zimbabwe HIV Data:

  • Prevalence: ~11.9% adults (15–49)
  • PLHIV: ~1.3 million
  • New infections/year: ~33,000
  • Most at risk: Young women aged 15–24

Global HIV Data:

  • PLHIV globally: ~39 million
  • New infections/year: ~1.3 million
  • AIDS deaths/year: ~630,000
  • On ART: ~30 million
  • UNAIDS target: 95-95-95 by 2025

India’s Role:

  • CIPLA: First affordable ARV ($1/day, 2001); manufactured generics for Africa
  • Indian generic ARV share: ~80% of low-income country HIV treatment
  • MPP licence: Gilead licensed generic lenacapavir to Indian firms

Key Institutions:

  • PEPFAR (2003): US bilateral HIV programme; world’s largest; funds African treatment
  • UNAIDS: UN programme coordinating global AIDS response
  • MPP: Medicines Patent Pool; UN-backed; negotiates generic licences
  • Gilead Sciences: US biotech; makes Truvada (oral PrEP), Biktarvy, Lenacapavir

Other Relevant Facts:

  • Oral PrEP (Truvada): Tenofovir + Emtricitabine; >99% effective with daily adherence; available as generic in India
  • ART (Antiretroviral Therapy): Suppresses HIV viral load to undetectable; U=U (Undetectable = Untransmittable)
  • HIV in India: ~2.5 million PLHIV (third largest globally after South Africa and Nigeria)
  • National AIDS Control Organisation (NACO): India’s nodal body; under Ministry of Health

Sources: Gilead Sciences, UNAIDS, The Hindu